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1. Safety of the PCSK9 inhibitor alirocumab: insights from 47 296 patient-years of observation

Author: Goodman, Shaun G, Goodman, Shaun G, Steg, Philippe Gabriel, Szarek, Michael, Bhatt, Deepak L, Bittner, Vera A, Diaz, Rafael, Harrington, Robert A, Jukema, J Wouter, White, Harvey D, Zeiher, Andreas M, Manvelian, Garen, Pordy, Robert, Poulouin, Yann, Stipek, Wanda, Garon, Genevieve, Schwartz, Gregory G, Steg, Ph Gabriel, Tricoci, Pierluigi, Roe, Matthew T, Mahaffey, Kenneth W, Edelberg, Jay M, Hanotin, Corinne, Lecorps, Guillaume, Moryusef, Angèle, Sasiela, William J, Tamby, Jean-François, Aylward, Philip E, Drexel, Heinz, Sinnaeve, Peter, Dilic, Mirza, Lopes, Renato D, Gotcheva, Nina N, Prieto, Juan-Carlos, Yong, Huo, López-Jaramillo, Patricio, Pećin, Ivan, Reiner, Zeljko, Ostadal, Petr, Poulsen, Steen Hvitfeldt, Viigimaa, Margus, Nieminen, Markku S, Danchin, Nicolas, Chumburidze, Vakhtang, Marx, Nikolaus, Liberopoulos, Evangelos, Valdovinos, Pablo Carlos Montenegro, Tse, Hung-Fat, Kiss, Robert Gabor, Xavier, Denis, Zahger, Doron, Valgimigli, Marco, Kimura, Takeshi, Kim, Hyo Soo, Kim, Sang-Hyun, Erglis, Andrejs, Laucevicius, Aleksandras, Kedev, Sasko, Yusoff, Khalid, López, Gabriel Arturo Ramos, Alings, Marco, Halvorsen, Sigrun, Flores, Roger M Correa, Sy, Rody G, Budaj, Andrzej, Morais, Joao, Dorobantu, Maria, Karpov, Yuri, Ristic, Arsen D, Chua, Terrance, Murin, Jan, Fras, Zlatko, Dalby, Anthony J, Tuñón, José, de Silva, H Asita, Hagström, Emil, Landmesser, Ulf, Chiang, Chern-En, Sritara, Piyamitr, Guneri, Sema, Parkhomenko, Alexander, Ray, Kausik K, Moriarty, Patrick M, Chaitman, Bernard, Kelsey, Sheryl F, Olsson, Anders G, Rouleau, Jean-Lucien, Goodman, Shaun G, Goodman, Shaun G, Steg, Philippe Gabriel, Szarek, Michael, Bhatt, Deepak L, Bittner, Vera A, Diaz, Rafael, Harrington, Robert A, Jukema, J Wouter, White, Harvey D, Zeiher, Andreas M, Manvelian, Garen, Pordy, Robert, Poulouin, Yann, Stipek, Wanda, Garon, Genevieve, Schwartz, Gregory G, Steg, Ph Gabriel, Tricoci, Pierluigi, Roe, Matthew T, Mahaffey, Kenneth W, Edelberg, Jay M, Hanotin, Corinne, Lecorps, Guillaume, Moryusef, Angèle, Sasiela, William J, Tamby, Jean-François, Aylward, Philip E, Drexel, Heinz, Sinnaeve, Peter, Dilic, Mirza, Lopes, Renato D, Gotcheva, Nina N, Prieto, Juan-Carlos, Yong, Huo, López-Jaramillo, Patricio, Pećin, Ivan, Reiner, Zeljko, Ostadal, Petr, Poulsen, Steen Hvitfeldt, Viigimaa, Margus, Nieminen, Markku S, Danchin, Nicolas, Chumburidze, Vakhtang, Marx, Nikolaus, Liberopoulos, Evangelos, Valdovinos, Pablo Carlos Montenegro, Tse, Hung-Fat, Kiss, Robert Gabor, Xavier, Denis, Zahger, Doron, Valgimigli, Marco, Kimura, Takeshi, Kim, Hyo Soo, Kim, Sang-Hyun, Erglis, Andrejs, Laucevicius, Aleksandras, Kedev, Sasko, Yusoff, Khalid, López, Gabriel Arturo Ramos, Alings, Marco, Halvorsen, Sigrun, Flores, Roger M Correa, Sy, Rody G, Budaj, Andrzej, Morais, Joao, Dorobantu, Maria, Karpov, Yuri, Ristic, Arsen D, Chua, Terrance, Murin, Jan, Fras, Zlatko, Dalby, Anthony J, Tuñón, José, de Silva, H Asita, Hagström, Emil, Landmesser, Ulf, Chiang, Chern-En, Sritara, Piyamitr, Guneri, Sema, Parkhomenko, Alexander, Ray, Kausik K, Moriarty, Patrick M, Chaitman, Bernard, Kelsey, Sheryl F, Olsson, Anders G, and Rouleau, Jean-Lucien
Abstract: The ODYSSEY OUTCOMES trial, comprising over 47 000 patient-years of placebo-controlled observation, demonstrated important reductions in the risk of recurrent ischaemic cardiovascular events with the monoclonal antibody to proprotein convertase subtilisin/kexin type 9 alirocumab, as well as lower all-cause death. These benefits were observed in the context of substantial and persistent lowering of low-density lipoprotein cholesterol with alirocumab compared with that achieved with placebo. The safety profile of alirocumab was indistinguishable from matching placebo except for a ∼1.7% absolute increase in local injection site reactions. Further, the safety of alirocumab compared with placebo was evident in vulnerable groups identified before randomization, such as the elderly and those with diabetes mellitus, previous ischaemic stroke, or chronic kidney disease. The frequency of adverse events and laboratory-based abnormalities was generally similar to that in placebo-treated patients. Thus, alirocumab appears to be a safe and effective lipid-modifying treatment over a duration of at least 5 years.
Published: 2024

2. Apolipoprotein B, Residual Cardiovascular Risk After Acute Coronary Syndrome, and Effects of Alirocumab.

Author: Hagström, Emil, Hagström, Emil, Steg, P Gabriel, Szarek, Michael, Bhatt, Deepak L, Bittner, Vera A, Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G, Harrington, Robert A, Jukema, J Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D, Zeiher, Andreas M, Yang, Eric, Schwartz, Gregory G, Hagström, Emil, Hagström, Emil, Steg, P Gabriel, Szarek, Michael, Bhatt, Deepak L, Bittner, Vera A, Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G, Harrington, Robert A, Jukema, J Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D, Zeiher, Andreas M, Yang, Eric, and Schwartz, Gregory G
Abstract: Apolipoprotein B (apoB) provides an integrated measure of atherogenic risk. Whether apoB levels and apoB lowering hold incremental predictive information on residual risk after acute coronary syndrome beyond that provided by low-density lipoprotein cholesterol is uncertain.The ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) compared the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin therapy. Primary outcome was major adverse cardiovascular events (MACE; coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, hospitalization for unstable angina). Associations between baseline apoB or apoB at 4 months and MACE were assessed in adjusted Cox proportional hazards and propensity score-matched models.Median follow-up was 2.8 years. In proportional hazards analysis in the placebo group, MACE incidence increased across increasing baseline apoB strata (3.2 [95% CI, 2.9-3.6], 4.0 [95% CI, 3.6-4.5], and 5.5 [95% CI, 5.0-6.1] events per 100 patient-years in strata <75, 75-<90, ≥90 mg/dL, respectively; Ptrend<0.0001) and after adjustment for low-density lipoprotein cholesterol (Ptrend=0.035). Higher baseline apoB stratum was associated with greater relative (Ptrend<0.0001) and absolute reduction in MACE with alirocumab versus placebo. In the alirocumab group, the incidence of MACE after month 4 decreased monotonically across decreasing achieved apoB strata (4.26 [95% CI, 3.78-4.79], 3.09 [95% CI, 2.69-3.54], and 2.41 [95% CI, 2.11-2.76] events per 100 patient-years in strata ≥50, >35-<50, and ≤35 mg/dL, respectively). Compared with propensity score-matched patients from the placebo group, treatment hazard ratios for alirocumab also decreased monotonically across achieved apoB strata. Achieved apoB
Published: 2022

3. Apolipoprotein B, Residual Cardiovascular Risk After Acute Coronary Syndrome, and Effects of Alirocumab

Author: Hagström, Emil, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L., Bittner, Vera A., Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D., Zeiher, Andreas M., Schwartz, Gregory G., Hagström, Emil, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L., Bittner, Vera A., Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D., Zeiher, Andreas M., and Schwartz, Gregory G.
Abstract: BACKGROUND: Apolipoprotein B (apoB) provides an integrated measure of atherogenic risk. Whether apoB levels and apoB lowering hold incremental predictive information on residual risk after acute coronary syndrome beyond that provided by low-density lipoprotein cholesterol is uncertain. METHODS: The ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) compared the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin therapy. Primary outcome was major adverse cardiovascular events (MACE; coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, hospitalization for unstable angina). Associations between baseline apoB or apoB at 4 months and MACE were assessed in adjusted Cox proportional hazards and propensity score-matched models. RESULTS: Median follow-up was 2.8 years. In proportional hazards analysis in the placebo group, MACE incidence increased across increasing baseline apoB strata (3.2 [95% CI, 2.9-3.6], 4.0 [95% CI, 3.6-4.5], and 5.5 [95% CI, 5.0-6.1] events per 100 patient-years in strata <75, 75-<90, >= 90 mg/dL, respectively; P-trend<0.0001) and after adjustment for low-density lipoprotein cholesterol (P-trend=0.035). Higher baseline apoB stratum was associated with greater relative (P-trend<0.0001) and absolute reduction in MACE with alirocumab versus placebo. In the alirocumab group, the incidence of MACE after month 4 decreased monotonically across decreasing achieved apoB strata (4.26 [95% CI, 3.78-4.79], 3.09 [95% CI, 2.69-3.54], and 2.41 [95% CI, 2.11-2.76] events per 100 patient-years in strata >= 50, >35-<50, and <= 35 mg/dL, respectively). Compared with propensity score-matched patients from the placebo group, treatment hazard ratios for alirocumab also decreased monoto
Published: 2022
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4. Apolipoprotein B, Residual Cardiovascular Risk After Acute Coronary Syndrome, and Effects of Alirocumab

Author: Hagström, Emil, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L., Bittner, Vera A., Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D., Zeiher, Andreas M., Schwartz, Gregory G., Hagström, Emil, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L., Bittner, Vera A., Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D., Zeiher, Andreas M., and Schwartz, Gregory G.
Abstract: BACKGROUND: Apolipoprotein B (apoB) provides an integrated measure of atherogenic risk. Whether apoB levels and apoB lowering hold incremental predictive information on residual risk after acute coronary syndrome beyond that provided by low-density lipoprotein cholesterol is uncertain. METHODS: The ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) compared the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin therapy. Primary outcome was major adverse cardiovascular events (MACE; coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, hospitalization for unstable angina). Associations between baseline apoB or apoB at 4 months and MACE were assessed in adjusted Cox proportional hazards and propensity score-matched models. RESULTS: Median follow-up was 2.8 years. In proportional hazards analysis in the placebo group, MACE incidence increased across increasing baseline apoB strata (3.2 [95% CI, 2.9-3.6], 4.0 [95% CI, 3.6-4.5], and 5.5 [95% CI, 5.0-6.1] events per 100 patient-years in strata <75, 75-<90, >= 90 mg/dL, respectively; P-trend<0.0001) and after adjustment for low-density lipoprotein cholesterol (P-trend=0.035). Higher baseline apoB stratum was associated with greater relative (P-trend<0.0001) and absolute reduction in MACE with alirocumab versus placebo. In the alirocumab group, the incidence of MACE after month 4 decreased monotonically across decreasing achieved apoB strata (4.26 [95% CI, 3.78-4.79], 3.09 [95% CI, 2.69-3.54], and 2.41 [95% CI, 2.11-2.76] events per 100 patient-years in strata >= 50, >35-<50, and <= 35 mg/dL, respectively). Compared with propensity score-matched patients from the placebo group, treatment hazard ratios for alirocumab also decreased monoto
Published: 2022
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5. Apolipoprotein B, Residual Cardiovascular Risk After Acute Coronary Syndrome, and Effects of Alirocumab

Author: Hagström, Emil, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L., Bittner, Vera A., Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D., Zeiher, Andreas M., Schwartz, Gregory G., Hagström, Emil, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L., Bittner, Vera A., Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D., Zeiher, Andreas M., and Schwartz, Gregory G.
Abstract: BACKGROUND: Apolipoprotein B (apoB) provides an integrated measure of atherogenic risk. Whether apoB levels and apoB lowering hold incremental predictive information on residual risk after acute coronary syndrome beyond that provided by low-density lipoprotein cholesterol is uncertain. METHODS: The ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) compared the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin therapy. Primary outcome was major adverse cardiovascular events (MACE; coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, hospitalization for unstable angina). Associations between baseline apoB or apoB at 4 months and MACE were assessed in adjusted Cox proportional hazards and propensity score-matched models. RESULTS: Median follow-up was 2.8 years. In proportional hazards analysis in the placebo group, MACE incidence increased across increasing baseline apoB strata (3.2 [95% CI, 2.9-3.6], 4.0 [95% CI, 3.6-4.5], and 5.5 [95% CI, 5.0-6.1] events per 100 patient-years in strata <75, 75-<90, >= 90 mg/dL, respectively; P-trend<0.0001) and after adjustment for low-density lipoprotein cholesterol (P-trend=0.035). Higher baseline apoB stratum was associated with greater relative (P-trend<0.0001) and absolute reduction in MACE with alirocumab versus placebo. In the alirocumab group, the incidence of MACE after month 4 decreased monotonically across decreasing achieved apoB strata (4.26 [95% CI, 3.78-4.79], 3.09 [95% CI, 2.69-3.54], and 2.41 [95% CI, 2.11-2.76] events per 100 patient-years in strata >= 50, >35-<50, and <= 35 mg/dL, respectively). Compared with propensity score-matched patients from the placebo group, treatment hazard ratios for alirocumab also decreased monoto
Published: 2022
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6. Apolipoprotein B, Residual Cardiovascular Risk After Acute Coronary Syndrome, and Effects of Alirocumab.

Author: Hagström, Emil, Hagström, Emil, Steg, P Gabriel, Szarek, Michael, Bhatt, Deepak L, Bittner, Vera A, Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G, Harrington, Robert A, Jukema, J Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D, Zeiher, Andreas M, Yang, Eric, Schwartz, Gregory G, Hagström, Emil, Hagström, Emil, Steg, P Gabriel, Szarek, Michael, Bhatt, Deepak L, Bittner, Vera A, Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G, Harrington, Robert A, Jukema, J Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D, Zeiher, Andreas M, Yang, Eric, and Schwartz, Gregory G
Abstract: Apolipoprotein B (apoB) provides an integrated measure of atherogenic risk. Whether apoB levels and apoB lowering hold incremental predictive information on residual risk after acute coronary syndrome beyond that provided by low-density lipoprotein cholesterol is uncertain.The ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) compared the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin therapy. Primary outcome was major adverse cardiovascular events (MACE; coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, hospitalization for unstable angina). Associations between baseline apoB or apoB at 4 months and MACE were assessed in adjusted Cox proportional hazards and propensity score-matched models.Median follow-up was 2.8 years. In proportional hazards analysis in the placebo group, MACE incidence increased across increasing baseline apoB strata (3.2 [95% CI, 2.9-3.6], 4.0 [95% CI, 3.6-4.5], and 5.5 [95% CI, 5.0-6.1] events per 100 patient-years in strata <75, 75-<90, ≥90 mg/dL, respectively; Ptrend<0.0001) and after adjustment for low-density lipoprotein cholesterol (Ptrend=0.035). Higher baseline apoB stratum was associated with greater relative (Ptrend<0.0001) and absolute reduction in MACE with alirocumab versus placebo. In the alirocumab group, the incidence of MACE after month 4 decreased monotonically across decreasing achieved apoB strata (4.26 [95% CI, 3.78-4.79], 3.09 [95% CI, 2.69-3.54], and 2.41 [95% CI, 2.11-2.76] events per 100 patient-years in strata ≥50, >35-<50, and ≤35 mg/dL, respectively). Compared with propensity score-matched patients from the placebo group, treatment hazard ratios for alirocumab also decreased monotonically across achieved apoB strata. Achieved apoB
Published: 2022

7. Apolipoprotein B, Residual Cardiovascular Risk After Acute Coronary Syndrome, and Effects of Alirocumab

Author: Hagström, Emil, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L., Bittner, Vera A., Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D., Zeiher, Andreas M., Schwartz, Gregory G., Hagström, Emil, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L., Bittner, Vera A., Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D., Zeiher, Andreas M., and Schwartz, Gregory G.
Abstract: BACKGROUND: Apolipoprotein B (apoB) provides an integrated measure of atherogenic risk. Whether apoB levels and apoB lowering hold incremental predictive information on residual risk after acute coronary syndrome beyond that provided by low-density lipoprotein cholesterol is uncertain. METHODS: The ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) compared the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin therapy. Primary outcome was major adverse cardiovascular events (MACE; coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, hospitalization for unstable angina). Associations between baseline apoB or apoB at 4 months and MACE were assessed in adjusted Cox proportional hazards and propensity score-matched models. RESULTS: Median follow-up was 2.8 years. In proportional hazards analysis in the placebo group, MACE incidence increased across increasing baseline apoB strata (3.2 [95% CI, 2.9-3.6], 4.0 [95% CI, 3.6-4.5], and 5.5 [95% CI, 5.0-6.1] events per 100 patient-years in strata <75, 75-<90, >= 90 mg/dL, respectively; P-trend<0.0001) and after adjustment for low-density lipoprotein cholesterol (P-trend=0.035). Higher baseline apoB stratum was associated with greater relative (P-trend<0.0001) and absolute reduction in MACE with alirocumab versus placebo. In the alirocumab group, the incidence of MACE after month 4 decreased monotonically across decreasing achieved apoB strata (4.26 [95% CI, 3.78-4.79], 3.09 [95% CI, 2.69-3.54], and 2.41 [95% CI, 2.11-2.76] events per 100 patient-years in strata >= 50, >35-<50, and <= 35 mg/dL, respectively). Compared with propensity score-matched patients from the placebo group, treatment hazard ratios for alirocumab also decreased monoto
Published: 2022
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8. Ultrasensitive Troponin I and Incident Cardiovascular Disease

Author: Empana, Jean-Philippe, Lerner, Ivan, Perier, Marie-Cécile, Guibout, Catherine, Jabre, Patricia, Bailly, Karine, Andrieu, Muriel, Climie, Rachel, van Sloten, Thomas, Vedie, Benoit, Geromin, Daniela, Marijon, Eloi, Thomas, Frederique, Danchin, Nicolas, Boutouyrie, Pierre, Jouven, Xavier, Empana, Jean-Philippe, Lerner, Ivan, Perier, Marie-Cécile, Guibout, Catherine, Jabre, Patricia, Bailly, Karine, Andrieu, Muriel, Climie, Rachel, van Sloten, Thomas, Vedie, Benoit, Geromin, Daniela, Marijon, Eloi, Thomas, Frederique, Danchin, Nicolas, Boutouyrie, Pierre, and Jouven, Xavier
Abstract: BACKGROUND: To examine the association of ultrasensitive cTnI (cardiac troponin I) with incident cardiovascular disease events (CVDs) in the primary prevention setting.METHODS: cTnI was analyzed in the baseline plasma (2008-2012) of CVD-free volunteers from the Paris Prospective Study III using a novel ultrasensitive immunoassay (Simoa Troponin-I 2.0 Kit, Quanterix, Lexington) with a limit of detection of 0.013 pg/mL. Incident CVD hospitalizations (coronary heart disease, stroke, cardiac arrhythmias, deep venous thrombosis or pulmonary embolism, heart failure, or arterial aneurysm) were validated by critical review of the hospital records. Hazard ratios were estimated per log-transformed SD increase of cTnI in Cox models using age as the time scale.RESULTS: The study population includes 9503 participants (40% women) aged 59.6 (6.3) years. cTnI was detected in 99.6% of the participants (median value=0.63 pg/mL, interquartile range, 0.39-1.09). After a median follow-up of 8.34 years (interquartile range, 8.0-10.07), 516 participants suffered 612 events. In fully adjusted analysis, higher cTnI (per 1 SD increase of log cTnI) was significantly associated with CVD events combined (hazard ratio, 1.18 [1.08-1.30]). Among all single risk factors, cTnI had the highest discrimination capacity for incident CVD events (C index=0.6349). Adding log cTnI to the SCORE 2 (Systematic Coronary Risk Evaluation) risk improved moderately discriminatory capacity (C index 0.698 versus 0.685; bootstrapped C index difference: 0.0135 [95% CI, 0.0131-0.0138]), and reclassification of the participants (categorical net reclassification index, 0.0628 [95% CI, 0.023-0.102]). Findings were consistent using the US pooled cohort risk equation.CONCLUSIONS: Ultrasensitive cTnI is an independent marker of CVD events in the primary prevention setting.
Published: 2022

9. Apolipoprotein B, Residual Cardiovascular Risk After Acute Coronary Syndrome, and Effects of Alirocumab

Author: Hagström, Emil, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L., Bittner, Vera A., Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D., Zeiher, Andreas M., Schwartz, Gregory G., Hagström, Emil, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L., Bittner, Vera A., Danchin, Nicolas, Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Liberopoulos, Evangelos, Marx, Nikolaus, McGinniss, Jennifer, Manvelian, Garen, Pordy, Robert, Scemama, Michel, White, Harvey D., Zeiher, Andreas M., and Schwartz, Gregory G.
Abstract: BACKGROUND: Apolipoprotein B (apoB) provides an integrated measure of atherogenic risk. Whether apoB levels and apoB lowering hold incremental predictive information on residual risk after acute coronary syndrome beyond that provided by low-density lipoprotein cholesterol is uncertain. METHODS: The ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) compared the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin therapy. Primary outcome was major adverse cardiovascular events (MACE; coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, hospitalization for unstable angina). Associations between baseline apoB or apoB at 4 months and MACE were assessed in adjusted Cox proportional hazards and propensity score-matched models. RESULTS: Median follow-up was 2.8 years. In proportional hazards analysis in the placebo group, MACE incidence increased across increasing baseline apoB strata (3.2 [95% CI, 2.9-3.6], 4.0 [95% CI, 3.6-4.5], and 5.5 [95% CI, 5.0-6.1] events per 100 patient-years in strata <75, 75-<90, >= 90 mg/dL, respectively; P-trend<0.0001) and after adjustment for low-density lipoprotein cholesterol (P-trend=0.035). Higher baseline apoB stratum was associated with greater relative (P-trend<0.0001) and absolute reduction in MACE with alirocumab versus placebo. In the alirocumab group, the incidence of MACE after month 4 decreased monotonically across decreasing achieved apoB strata (4.26 [95% CI, 3.78-4.79], 3.09 [95% CI, 2.69-3.54], and 2.41 [95% CI, 2.11-2.76] events per 100 patient-years in strata >= 50, >35-<50, and <= 35 mg/dL, respectively). Compared with propensity score-matched patients from the placebo group, treatment hazard ratios for alirocumab also decreased monoto
Published: 2022
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10. APRIL limits atherosclerosis by binding to heparan sulfate proteoglycans

Author: Centraal Diagnostisch Laboratorium, Circulatory Health, Tsiantoulas, Dimitrios, Eslami, Mahya, Obermayer, Georg, Clement, Marc, Smeets, Diede, Mayer, Florian J, Kiss, Máté G, Enders, Lennart, Weißer, Juliane, Göderle, Laura, Lambert, Jordi, Frommlet, Florian, Mueller, André, Hendrikx, Tim, Ozsvar-Kozma, Maria, Porsch, Florentina, Willen, Laure, Afonyushkin, Taras, Murphy, Jane E, Fogelstrand, Per, Donzé, Olivier, Pasterkamp, Gerard, Hoke, Matthias, Kubicek, Stefan, Jørgensen, Helle F, Danchin, Nicolas, Simon, Tabassome, Scharnagl, Hubert, März, Winfried, Borén, Jan, Hess, Henry, Mallat, Ziad, Schneider, Pascal, Binder, Christoph J, Centraal Diagnostisch Laboratorium, Circulatory Health, Tsiantoulas, Dimitrios, Eslami, Mahya, Obermayer, Georg, Clement, Marc, Smeets, Diede, Mayer, Florian J, Kiss, Máté G, Enders, Lennart, Weißer, Juliane, Göderle, Laura, Lambert, Jordi, Frommlet, Florian, Mueller, André, Hendrikx, Tim, Ozsvar-Kozma, Maria, Porsch, Florentina, Willen, Laure, Afonyushkin, Taras, Murphy, Jane E, Fogelstrand, Per, Donzé, Olivier, Pasterkamp, Gerard, Hoke, Matthias, Kubicek, Stefan, Jørgensen, Helle F, Danchin, Nicolas, Simon, Tabassome, Scharnagl, Hubert, März, Winfried, Borén, Jan, Hess, Henry, Mallat, Ziad, Schneider, Pascal, and Binder, Christoph J
Published: 2021

11. The effect of intravenous ferric carboxymaltose on health-related quality of life in iron-deficient patients with acute heart failure: the results of the AFFIRM-AHF study

Author: Jankowska, Ewa A; https://orcid.org/0000-0002-9202-432X, Kirwan, Bridget-Anne, Kosiborod, Mikhail; https://orcid.org/0000-0002-3750-9789, Butler, Javed, Anker, Stefan D, McDonagh, Theresa, Dorobantu, Maria; https://orcid.org/0000-0003-1940-5262, Drozdz, Jarosław; https://orcid.org/0000-0002-0732-2104, Filippatos, Gerasimos; https://orcid.org/0000-0002-5640-0332, Keren, Andre; https://orcid.org/0000-0001-6575-4901, Khintibidze, Irakli, Kragten, Hans, Martinez, Felipe A, Metra, Marco, Milicic, Davor, Nicolau, José C; https://orcid.org/0000-0002-9680-3689, Ohlsson, Marcus; https://orcid.org/0000-0003-0043-1727, Parkhomenko, Alexander, Pascual-Figal, Domingo A; https://orcid.org/0000-0002-4993-9540, Ruschitzka, Frank; https://orcid.org/0000-0001-5972-0596, Sim, David, Skouri, Hadi; https://orcid.org/0000-0003-0541-4926, van der Meer, Peter, Lewis, Basil S; https://orcid.org/0000-0001-5604-6399, Comin-Colet, Josep; https://orcid.org/0000-0001-8780-720X, von Haehling, Stephan, Cohen-Solal, Alain, Danchin, Nicolas; https://orcid.org/0000-0001-9263-5051, Doehner, Wolfram; https://orcid.org/0000-0001-7598-708X, Dargie, Henry J, et al, Jankowska, Ewa A; https://orcid.org/0000-0002-9202-432X, Kirwan, Bridget-Anne, Kosiborod, Mikhail; https://orcid.org/0000-0002-3750-9789, Butler, Javed, Anker, Stefan D, McDonagh, Theresa, Dorobantu, Maria; https://orcid.org/0000-0003-1940-5262, Drozdz, Jarosław; https://orcid.org/0000-0002-0732-2104, Filippatos, Gerasimos; https://orcid.org/0000-0002-5640-0332, Keren, Andre; https://orcid.org/0000-0001-6575-4901, Khintibidze, Irakli, Kragten, Hans, Martinez, Felipe A, Metra, Marco, Milicic, Davor, Nicolau, José C; https://orcid.org/0000-0002-9680-3689, Ohlsson, Marcus; https://orcid.org/0000-0003-0043-1727, Parkhomenko, Alexander, Pascual-Figal, Domingo A; https://orcid.org/0000-0002-4993-9540, Ruschitzka, Frank; https://orcid.org/0000-0001-5972-0596, Sim, David, Skouri, Hadi; https://orcid.org/0000-0003-0541-4926, van der Meer, Peter, Lewis, Basil S; https://orcid.org/0000-0001-5604-6399, Comin-Colet, Josep; https://orcid.org/0000-0001-8780-720X, von Haehling, Stephan, Cohen-Solal, Alain, Danchin, Nicolas; https://orcid.org/0000-0001-9263-5051, Doehner, Wolfram; https://orcid.org/0000-0001-7598-708X, Dargie, Henry J, and et al
Abstract: AIMS Patients with heart failure (HF) and iron deficiency experience poor health-related quality of life (HRQoL). We evaluated the impact of intravenous (IV) ferric carboxymaltose (FCM) vs. placebo on HRQoL for the AFFIRM-AHF population. METHODS AND RESULTS The baseline 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), which was completed for 1058 (535 and 523) patients in the FCM and placebo groups, respectively, was administered prior to randomization and at Weeks 2, 4, 6, 12, 24, 36, and 52. The baseline KCCQ-12 overall summary score (OSS) mean ± standard error was 38.7 ± 0.9 (FCM group) and 37.1 ± 0.8 (placebo group); corresponding values for the clinical summary score (CSS) were 40.9 ± 0.9 and 40.1 ± 0.9. At Week 2, changes in OSS and CSS were similar for FCM and placebo. From Week 4 to Week 24, patients assigned to FCM had significantly greater improvements in OSS and CSS scores vs. placebo [adjusted mean difference (95% confidence interval, CI) at Week 4: 2.9 (0.5-5.3, P = 0.018) for OSS and 2.8 (0.3-5.3, P = 0.029) for CSS; adjusted mean difference (95% CI) at Week 24: 3.0 (0.3-5.6, P = 0.028) for OSS and 2.9 (0.2-5.6, P = 0.035) for CSS]. At Week 52, the treatment effect had attenuated but remained in favour of FCM. CONCLUSION In iron-deficient patients with HF and left ventricular ejection fraction ≤50% who had stabilized after an episode of acute HF, treatment with IV FCM, compared with placebo, results in clinically meaningful beneficial effects on HRQoL as early as 4 weeks after treatment initiation, lasting up to Week 24.
Published: 2021

12. Association of factor v leiden with subsequent atherothrombotic events: A GENIUS-CHD study of individual participant data

Author: Mahmoodi, Bakhtawar K., Tragante, Vinicius, Kleber, Marcus E., Holmes, Michael V., Schmidt, Amand F., McCubrey, Raymond O., Howe, Laurence J., Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V., Braund, Peter S., Delgado, Graciela E., Eriksson, Niclas, Gijsberts, Crystel M., Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjärvi, Pekka, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Muehlschlegel, Jochen D., Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Wilson Tang, W. H., Van Der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R., Teren, Andrej, Bergmeijer, Thomas O., Body, Simon C., Bots, Michiel, Burkhardt, Ralph, Cooper-Dehoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N., Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hoefer, Imo E., Hovingh, G. Kees, Johnson, Julie A., Kaczor, Marcin P., Kähönen, Mika, Klungel, Olaf H., Laurikka, Jari O., Lehtimäki, Terho, Maitland-Van Der Zee, Anke H., McPherson, Ruth, Palmer, Colin N., Kraaijeveld, Adriaan O., Pepine, Carl J., Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A., Stewart, Alexandre F.R., Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L.J., Waltenberger, Johannes, Richards, A. Mark, Lang, Chim C., Cameron, Vicky A., Åkerblom, Axel, Pare, Guillaume, März, Winfried, Samani, Nilesh J., Hingorani, Aroon D., Ten Berg, Jurriën M., Wallentin, Lars, Asselbergs, Folkert W., Patel, Riyaz S., Mahmoodi, Bakhtawar K., Tragante, Vinicius, Kleber, Marcus E., Holmes, Michael V., Schmidt, Amand F., McCubrey, Raymond O., Howe, Laurence J., Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V., Braund, Peter S., Delgado, Graciela E., Eriksson, Niclas, Gijsberts, Crystel M., Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjärvi, Pekka, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Muehlschlegel, Jochen D., Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Wilson Tang, W. H., Van Der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R., Teren, Andrej, Bergmeijer, Thomas O., Body, Simon C., Bots, Michiel, Burkhardt, Ralph, Cooper-Dehoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N., Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hoefer, Imo E., Hovingh, G. Kees, Johnson, Julie A., Kaczor, Marcin P., Kähönen, Mika, Klungel, Olaf H., Laurikka, Jari O., Lehtimäki, Terho, Maitland-Van Der Zee, Anke H., McPherson, Ruth, Palmer, Colin N., Kraaijeveld, Adriaan O., Pepine, Carl J., Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A., Stewart, Alexandre F.R., Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L.J., Waltenberger, Johannes, Richards, A. Mark, Lang, Chim C., Cameron, Vicky A., Åkerblom, Axel, Pare, Guillaume, März, Winfried, Samani, Nilesh J., Hingorani, Aroon D., Ten Berg, Jurriën M., Wallentin, Lars, Asselbergs, Folkert W., and Patel, Riyaz S.
Abstract: Background: Studies examining the role of factor V Leiden among patients at higher risk of atherothrombotic events, such as those with established coronary heart disease (CHD), are lacking. Given that coagulation is involved in the thrombus formation stage on atherosclerotic plaque rupture, we hypothesized that factor V Leiden may be a stronger risk factor for atherothrombotic events in patients with established CHD. Methods: We performed an individual-level meta-analysis including 25 prospective studies (18 cohorts, 3 case-cohorts, 4 randomized trials) from the GENIUS-CHD (Genetics of Subsequent Coronary Heart Disease) consortium involving patients with established CHD at baseline. Participating studies genotyped factor V Leiden status and shared risk estimates for the outcomes of interest using a centrally developed statistical code with harmonized definitions across studies. Cox proportional hazards regression models were used to obtain age- and sex-adjusted estimates. The obtained estimates were pooled using fixed-effect meta-analysis. The primary outcome was composite of myocardial infarction and CHD death. Secondary outcomes included any stroke, ischemic stroke, coronary revascularization, cardiovascular mortality, and all-cause mortality. Results: The studies included 69 681 individuals of whom 3190 (4.6%) were either heterozygous or homozygous (n=47) carriers of factor V Leiden. Median follow-up per study ranged from 1.0 to 10.6 years. A total of 20 studies with 61 147 participants and 6849 events contributed to analyses of the primary outcome. Factor V Leiden was not associated with the combined outcome of myocardial infarction and CHD death (hazard ratio, 1.03 [95% CI, 0.92-1.16]; I2=28%; P-heterogeneity=0.12). Subgroup analysis according to baseline characteristics or strata of traditional cardiovascular risk factors did not show relevant differences. Similarly, risk estimates for the secondary outcomes including stroke, coronary revasculari
Published: 2020

13. Association of Factor V Leiden With Subsequent Atherothrombotic Events A GENIUS-CHD Study of Individual Participant Data

Author: Mahmoodi, Bakhtawar K., Tragante, Vinicius, Kleber, Marcus E., Holmes, Michael V., Schmidt, Amand F., McCubrey, Raymond O., Howe, Laurence J., Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V., Braund, Peter S., Delgado, Graciela E., Eriksson, Niclas, Gijsberts, Crystel M., Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjarvi, Pekka, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Muehlschlegel, Jochen D., Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Wilson Tang, W. H., van der Laan, Sander W., van Setten, Jessica, Vilmundarson, Ragnar O., Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R., Teren, Andrej, Bergmeijer, Thomas O., Body, Simon C., Bots, Michiel, Burkhardt, Ralph, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N., Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hoefer, Imo E., Hovingh, G. Kees, Johnson, Julie A., Kaczor, Marcin P., Kahonen, Mika, Klungel, Olaf H., Laurikka, Jari O., Lehtimaki, Terho, van der Zee, Anke H., McPherson, Ruth, Palmer, Colin N., Kraaijeveld, Adriaan O., Pepine, Carl J., Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A., Stewart, Alexandre F. R., Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L. J., Waltenberger, Johannes, Richards, A. Mark, Lang, Chim C., Cameron, Vicky A., Åkerblom, Axel, Pare, Guillaume, Maerz, Winfried, Samani, Nilesh J., Hingorani, Aroon D., ten Berg, Jurrien M., Wallentin, Lars, Asselbergs, Folkert W., Patel, Riyaz S., Mahmoodi, Bakhtawar K., Tragante, Vinicius, Kleber, Marcus E., Holmes, Michael V., Schmidt, Amand F., McCubrey, Raymond O., Howe, Laurence J., Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V., Braund, Peter S., Delgado, Graciela E., Eriksson, Niclas, Gijsberts, Crystel M., Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjarvi, Pekka, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Muehlschlegel, Jochen D., Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Wilson Tang, W. H., van der Laan, Sander W., van Setten, Jessica, Vilmundarson, Ragnar O., Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R., Teren, Andrej, Bergmeijer, Thomas O., Body, Simon C., Bots, Michiel, Burkhardt, Ralph, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N., Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hoefer, Imo E., Hovingh, G. Kees, Johnson, Julie A., Kaczor, Marcin P., Kahonen, Mika, Klungel, Olaf H., Laurikka, Jari O., Lehtimaki, Terho, van der Zee, Anke H., McPherson, Ruth, Palmer, Colin N., Kraaijeveld, Adriaan O., Pepine, Carl J., Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A., Stewart, Alexandre F. R., Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L. J., Waltenberger, Johannes, Richards, A. Mark, Lang, Chim C., Cameron, Vicky A., Åkerblom, Axel, Pare, Guillaume, Maerz, Winfried, Samani, Nilesh J., Hingorani, Aroon D., ten Berg, Jurrien M., Wallentin, Lars, Asselbergs, Folkert W., and Patel, Riyaz S.
Abstract: Background: Studies examining the role of factor V Leiden among patients at higher risk of atherothrombotic events, such as those with established coronary heart disease (CHD), are lacking. Given that coagulation is involved in the thrombus formation stage on atherosclerotic plaque rupture, we hypothesized that factor V Leiden may be a stronger risk factor for atherothrombotic events in patients with established CHD. Methods: We performed an individual-level meta-analysis including 25 prospective studies (18 cohorts, 3 case-cohorts, 4 randomized trials) from the GENIUS-CHD (Genetics of Subsequent Coronary Heart Disease) consortium involving patients with established CHD at baseline. Participating studies genotyped factor V Leiden status and shared risk estimates for the outcomes of interest using a centrally developed statistical code with harmonized definitions across studies. Cox proportional hazards regression models were used to obtain age- and sex-adjusted estimates. The obtained estimates were pooled using fixed-effect meta-analysis. The primary outcome was composite of myocardial infarction and CHD death. Secondary outcomes included any stroke, ischemic stroke, coronary revascularization, cardiovascular mortality, and all-cause mortality. Results: The studies included 69 681 individuals of whom 3190 (4.6%) were either heterozygous or homozygous (n=47) carriers of factor V Leiden. Median follow-up per study ranged from 1.0 to 10.6 years. A total of 20 studies with 61 147 participants and 6849 events contributed to analyses of the primary outcome. Factor V Leiden was not associated with the combined outcome of myocardial infarction and CHD death (hazard ratio, 1.03 [95% CI, 0.92-1.16];I-2=28%;P-heterogeneity=0.12). Subgroup analysis according to baseline characteristics or strata of traditional cardiovascular risk factors did not show relevant differences. Similarly, risk estimates for the secondary outcomes including stroke, coronary revascularization, cardiov
Published: 2020
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14. Association of factor v leiden with subsequent atherothrombotic events: A GENIUS-CHD study of individual participant data

Author: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Mahmoodi, Bakhtawar K., Tragante, Vinicius, Kleber, Marcus E., Holmes, Michael V., Schmidt, Amand F., McCubrey, Raymond O., Howe, Laurence J., Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V., Braund, Peter S., Delgado, Graciela E., Eriksson, Niclas, Gijsberts, Crystel M., Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjärvi, Pekka, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Muehlschlegel, Jochen D., Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Wilson Tang, W. H., Van Der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R., Teren, Andrej, Bergmeijer, Thomas O., Body, Simon C., Bots, Michiel, Burkhardt, Ralph, Cooper-Dehoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N., Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hoefer, Imo E., Hovingh, G. Kees, Johnson, Julie A., Kaczor, Marcin P., Kähönen, Mika, Klungel, Olaf H., Laurikka, Jari O., Lehtimäki, Terho, Maitland-Van Der Zee, Anke H., McPherson, Ruth, Palmer, Colin N., Kraaijeveld, Adriaan O., Pepine, Carl J., Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A., Stewart, Alexandre F.R., Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L.J., Waltenberger, Johannes, Richards, A. Mark, Lang, Chim C., Cameron, Vicky A., Åkerblom, Axel, Pare, Guillaume, März, Winfried, Samani, Nilesh J., Hingorani, Aroon D., Ten Berg, Jurriën M., Wallentin, Lars, Asselbergs, Folkert W., Patel, Riyaz S., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Mahmoodi, Bakhtawar K., Tragante, Vinicius, Kleber, Marcus E., Holmes, Michael V., Schmidt, Amand F., McCubrey, Raymond O., Howe, Laurence J., Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V., Braund, Peter S., Delgado, Graciela E., Eriksson, Niclas, Gijsberts, Crystel M., Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjärvi, Pekka, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Muehlschlegel, Jochen D., Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Wilson Tang, W. H., Van Der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R., Teren, Andrej, Bergmeijer, Thomas O., Body, Simon C., Bots, Michiel, Burkhardt, Ralph, Cooper-Dehoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N., Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hoefer, Imo E., Hovingh, G. Kees, Johnson, Julie A., Kaczor, Marcin P., Kähönen, Mika, Klungel, Olaf H., Laurikka, Jari O., Lehtimäki, Terho, Maitland-Van Der Zee, Anke H., McPherson, Ruth, Palmer, Colin N., Kraaijeveld, Adriaan O., Pepine, Carl J., Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A., Stewart, Alexandre F.R., Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L.J., Waltenberger, Johannes, Richards, A. Mark, Lang, Chim C., Cameron, Vicky A., Åkerblom, Axel, Pare, Guillaume, März, Winfried, Samani, Nilesh J., Hingorani, Aroon D., Ten Berg, Jurriën M., Wallentin, Lars, Asselbergs, Folkert W., and Patel, Riyaz S.
Published: 2020

15. Sleep apnoea is associated with hearing impairment: The Paris prospective study 3

Author: Lisan, Quentin, Lisan, Quentin, van Sloten, Thomas, Climie, Rachel E., Boutouyrie, Pierre, Guibout, Catherine, Thomas, Frederique, Danchin, Nicolas, Jouven, Xavier, Empana, Jean-Philippe, Lisan, Quentin, Lisan, Quentin, van Sloten, Thomas, Climie, Rachel E., Boutouyrie, Pierre, Guibout, Catherine, Thomas, Frederique, Danchin, Nicolas, Jouven, Xavier, and Empana, Jean-Philippe
Abstract: Objectives Hearing impairment (HI) is a leading impairment worldwide, and identifying modifiable risk factors of HI may have major public health implications. The aim of this study was to investigate the association between obstructive sleep apnoea (OSA) and HI.Design Observational longitudinal study (the Paris Prospective Study 3).Setting Population-based.Participants Volunteers aged 50-75 years and consulting at a preventive medical centre were included between 2008 and 2012. 6797 participants were included in the present analysis.Main outcome measures Audiometry testing was performed in both ears in all participants, and HI was defined by a pure-tone average (PTA) >25 decibels (dB) hearing level in the better ear.Results Obstructive sleep apnoea (estimated by the Berlin questionnaire) was present in 18.6% (n = 1267) and HI in 13.9% (n = 947) of the participants. Mean age was 59.5 years (SD 6.2) and 63.5% were male (n = 4317). In multiple logistic regression modelling, OSA was significantly associated with a 1.21-increased odds of HI (95% confidence interval 1.01-1.44). Several sensitivity analyses supported this finding.Conclusion Obstructive sleep apnoea is associated with a 21% increased odds of HI. These results support active screening of HI in subjects with OSA, and future studies should evaluate whether the treatment of OSA can delay the onset of HI.
Published: 2020

16. Depression, antidepressants and low hemoglobin level in the Paris Prospective Study III: A cross-sectional analysis

Author: Vulser, Helene, Vulser, Helene, Lemogne, Cedric, Boutouyrie, Pierre, Cote, Francine, Perier, Marie-Cecile, Van Sloten, Thomas, Hoertel, Nicolas, Danchin, Nicolas, Limosin, Frederic, Jouven, Xavier, Empana, Jean-Philippe, Vulser, Helene, Vulser, Helene, Lemogne, Cedric, Boutouyrie, Pierre, Cote, Francine, Perier, Marie-Cecile, Van Sloten, Thomas, Hoertel, Nicolas, Danchin, Nicolas, Limosin, Frederic, Jouven, Xavier, and Empana, Jean-Philippe
Abstract: Anemia is known to be associated with depression both in community and clinical populations. However, it is still unknown if this association depends or not on antidepressant intake. We investigated the respective association of depression and antidepressant intake with low hemoglobin level in a large community-based cohort. In 8640 volunteers aged 50 to 75 recruited between June 2008 and June 2012 in Paris (France), we assessed hemoglobin levels (g/dl), depressive symptoms and antidepressant intake. We examined the association of both depression and antidepressant intake with hemoglobin level, adjusting for numerous socio-demographic and health variables. We also assessed the association with specific antidepressant classes. Depression and anti-depressant intake were independently associated with lower hemoglobin level (beta = -0.074; p = .05 and beta = -0.100; p = .02 respectively in the fully-adjusted model). Regarding antidepressant classes, selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) intake were associated with lower hemoglobin level (beta = -0.11; p = .01). To conclude, both depression and antidepressant intake were associated with lower hemoglobin level. In particular, as SSRI or SNRIs intake was also related to lower hemoglobin level, these classes should be used with caution in depressed individuals at risk for anemia.
Published: 2020

17. Association of factor v leiden with subsequent atherothrombotic events: A GENIUS-CHD study of individual participant data

Author: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Mahmoodi, Bakhtawar K., Tragante, Vinicius, Kleber, Marcus E., Holmes, Michael V., Schmidt, Amand F., McCubrey, Raymond O., Howe, Laurence J., Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V., Braund, Peter S., Delgado, Graciela E., Eriksson, Niclas, Gijsberts, Crystel M., Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjärvi, Pekka, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Muehlschlegel, Jochen D., Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Wilson Tang, W. H., Van Der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R., Teren, Andrej, Bergmeijer, Thomas O., Body, Simon C., Bots, Michiel, Burkhardt, Ralph, Cooper-Dehoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N., Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hoefer, Imo E., Hovingh, G. Kees, Johnson, Julie A., Kaczor, Marcin P., Kähönen, Mika, Klungel, Olaf H., Laurikka, Jari O., Lehtimäki, Terho, Maitland-Van Der Zee, Anke H., McPherson, Ruth, Palmer, Colin N., Kraaijeveld, Adriaan O., Pepine, Carl J., Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A., Stewart, Alexandre F.R., Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L.J., Waltenberger, Johannes, Richards, A. Mark, Lang, Chim C., Cameron, Vicky A., Åkerblom, Axel, Pare, Guillaume, März, Winfried, Samani, Nilesh J., Hingorani, Aroon D., Ten Berg, Jurriën M., Wallentin, Lars, Asselbergs, Folkert W., Patel, Riyaz S., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Mahmoodi, Bakhtawar K., Tragante, Vinicius, Kleber, Marcus E., Holmes, Michael V., Schmidt, Amand F., McCubrey, Raymond O., Howe, Laurence J., Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V., Braund, Peter S., Delgado, Graciela E., Eriksson, Niclas, Gijsberts, Crystel M., Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjärvi, Pekka, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Muehlschlegel, Jochen D., Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Wilson Tang, W. H., Van Der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R., Teren, Andrej, Bergmeijer, Thomas O., Body, Simon C., Bots, Michiel, Burkhardt, Ralph, Cooper-Dehoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N., Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hoefer, Imo E., Hovingh, G. Kees, Johnson, Julie A., Kaczor, Marcin P., Kähönen, Mika, Klungel, Olaf H., Laurikka, Jari O., Lehtimäki, Terho, Maitland-Van Der Zee, Anke H., McPherson, Ruth, Palmer, Colin N., Kraaijeveld, Adriaan O., Pepine, Carl J., Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A., Stewart, Alexandre F.R., Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L.J., Waltenberger, Johannes, Richards, A. Mark, Lang, Chim C., Cameron, Vicky A., Åkerblom, Axel, Pare, Guillaume, März, Winfried, Samani, Nilesh J., Hingorani, Aroon D., Ten Berg, Jurriën M., Wallentin, Lars, Asselbergs, Folkert W., and Patel, Riyaz S.
Published: 2020

18. Association of factor v leiden with subsequent atherothrombotic events: A GENIUS-CHD study of individual participant data

Author: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Mahmoodi, Bakhtawar K., Tragante, Vinicius, Kleber, Marcus E., Holmes, Michael V., Schmidt, Amand F., McCubrey, Raymond O., Howe, Laurence J., Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V., Braund, Peter S., Delgado, Graciela E., Eriksson, Niclas, Gijsberts, Crystel M., Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjärvi, Pekka, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Muehlschlegel, Jochen D., Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Wilson Tang, W. H., Van Der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R., Teren, Andrej, Bergmeijer, Thomas O., Body, Simon C., Bots, Michiel, Burkhardt, Ralph, Cooper-Dehoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N., Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hoefer, Imo E., Hovingh, G. Kees, Johnson, Julie A., Kaczor, Marcin P., Kähönen, Mika, Klungel, Olaf H., Laurikka, Jari O., Lehtimäki, Terho, Maitland-Van Der Zee, Anke H., McPherson, Ruth, Palmer, Colin N., Kraaijeveld, Adriaan O., Pepine, Carl J., Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A., Stewart, Alexandre F.R., Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L.J., Waltenberger, Johannes, Richards, A. Mark, Lang, Chim C., Cameron, Vicky A., Åkerblom, Axel, Pare, Guillaume, März, Winfried, Samani, Nilesh J., Hingorani, Aroon D., Ten Berg, Jurriën M., Wallentin, Lars, Asselbergs, Folkert W., Patel, Riyaz S., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Mahmoodi, Bakhtawar K., Tragante, Vinicius, Kleber, Marcus E., Holmes, Michael V., Schmidt, Amand F., McCubrey, Raymond O., Howe, Laurence J., Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V., Braund, Peter S., Delgado, Graciela E., Eriksson, Niclas, Gijsberts, Crystel M., Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjärvi, Pekka, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Muehlschlegel, Jochen D., Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Wilson Tang, W. H., Van Der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R., Teren, Andrej, Bergmeijer, Thomas O., Body, Simon C., Bots, Michiel, Burkhardt, Ralph, Cooper-Dehoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N., Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hoefer, Imo E., Hovingh, G. Kees, Johnson, Julie A., Kaczor, Marcin P., Kähönen, Mika, Klungel, Olaf H., Laurikka, Jari O., Lehtimäki, Terho, Maitland-Van Der Zee, Anke H., McPherson, Ruth, Palmer, Colin N., Kraaijeveld, Adriaan O., Pepine, Carl J., Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A., Stewart, Alexandre F.R., Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L.J., Waltenberger, Johannes, Richards, A. Mark, Lang, Chim C., Cameron, Vicky A., Åkerblom, Axel, Pare, Guillaume, März, Winfried, Samani, Nilesh J., Hingorani, Aroon D., Ten Berg, Jurriën M., Wallentin, Lars, Asselbergs, Folkert W., and Patel, Riyaz S.
Published: 2020

19. Depression, antidepressants and low hemoglobin level in the Paris Prospective Study III: A cross-sectional analysis

Author: Vulser, Helene, Lemogne, Cedric, Boutouyrie, Pierre, Cote, Francine, Perier, Marie-Cecile, Van Sloten, Thomas, Hoertel, Nicolas, Danchin, Nicolas, Limosin, Frederic, Jouven, Xavier, Empana, Jean-Philippe, Vulser, Helene, Lemogne, Cedric, Boutouyrie, Pierre, Cote, Francine, Perier, Marie-Cecile, Van Sloten, Thomas, Hoertel, Nicolas, Danchin, Nicolas, Limosin, Frederic, Jouven, Xavier, and Empana, Jean-Philippe
Abstract: Anemia is known to be associated with depression both in community and clinical populations. However, it is still unknown if this association depends or not on antidepressant intake. We investigated the respective association of depression and antidepressant intake with low hemoglobin level in a large community-based cohort. In 8640 volunteers aged 50 to 75 recruited between June 2008 and June 2012 in Paris (France), we assessed hemoglobin levels (g/dl), depressive symptoms and antidepressant intake. We examined the association of both depression and antidepressant intake with hemoglobin level, adjusting for numerous socio-demographic and health variables. We also assessed the association with specific antidepressant classes. Depression and anti-depressant intake were independently associated with lower hemoglobin level (beta = -0.074; p = .05 and beta = -0.100; p = .02 respectively in the fully-adjusted model). Regarding antidepressant classes, selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) intake were associated with lower hemoglobin level (beta = -0.11; p = .01). To conclude, both depression and antidepressant intake were associated with lower hemoglobin level. In particular, as SSRI or SNRIs intake was also related to lower hemoglobin level, these classes should be used with caution in depressed individuals at risk for anemia.
Published: 2020

20. Sleep apnoea is associated with hearing impairment: The Paris prospective study 3

Author: Lisan, Quentin, van Sloten, Thomas, Climie, Rachel E., Boutouyrie, Pierre, Guibout, Catherine, Thomas, Frederique, Danchin, Nicolas, Jouven, Xavier, Empana, Jean-Philippe, Lisan, Quentin, van Sloten, Thomas, Climie, Rachel E., Boutouyrie, Pierre, Guibout, Catherine, Thomas, Frederique, Danchin, Nicolas, Jouven, Xavier, and Empana, Jean-Philippe
Abstract: Objectives Hearing impairment (HI) is a leading impairment worldwide, and identifying modifiable risk factors of HI may have major public health implications. The aim of this study was to investigate the association between obstructive sleep apnoea (OSA) and HI.Design Observational longitudinal study (the Paris Prospective Study 3).Setting Population-based.Participants Volunteers aged 50-75 years and consulting at a preventive medical centre were included between 2008 and 2012. 6797 participants were included in the present analysis.Main outcome measures Audiometry testing was performed in both ears in all participants, and HI was defined by a pure-tone average (PTA) >25 decibels (dB) hearing level in the better ear.Results Obstructive sleep apnoea (estimated by the Berlin questionnaire) was present in 18.6% (n = 1267) and HI in 13.9% (n = 947) of the participants. Mean age was 59.5 years (SD 6.2) and 63.5% were male (n = 4317). In multiple logistic regression modelling, OSA was significantly associated with a 1.21-increased odds of HI (95% confidence interval 1.01-1.44). Several sensitivity analyses supported this finding.Conclusion Obstructive sleep apnoea is associated with a 21% increased odds of HI. These results support active screening of HI in subjects with OSA, and future studies should evaluate whether the treatment of OSA can delay the onset of HI.
Published: 2020

21. Association of Factor V Leiden With Subsequent Atherothrombotic Events: A GENIUS-CHD Study of Individual Participant Data

Author: Onderzoek Precision medicine, Circulatory Health, CDL Onderzoek Pasterkamp, Cardiovasculaire Epidemiologie, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Global Health, CDL Arcadia, JC onderzoeksprogramma Methodologie, Team Medisch, Interne Geneeskunde Vasculaire, Mahmoodi, Bakhtawar K, Tragante, Vinicius, Kleber, Marcus E, Holmes, Michael V, Schmidt, Amand F, McCubrey, Raymond O, Howe, Laurence J, Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V, Braund, Peter S, Delgado, Graciela E, Eriksson, Niclas, Gijsberts, Crystel M, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjärvi, Pekka, Lenzini, Petra A, Levin, Daniel, Lyytikäinen, Leo-Pekka, Muehlschlegel, Jochen D, Nelson, Christopher P, Nikus, Kjell, Pilbrow, Anna P, Wilson Tang, W H, van der Laan, Sander W, van Setten, Jessica, Vilmundarson, Ragnar O, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R, Teren, Andrej, Bergmeijer, Thomas O, Body, Simon C, Bots, Michiel, Burkhardt, Ralph, Cooper-DeHoff, Rhonda M, Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N, Grobbee, Diederick E, Hagström, Emil, Hazen, Stanley L, Held, Claes, Hoefer, Imo E, Hovingh, G Kees, Johnson, Julie A, Kaczor, Marcin P, Kähönen, Mika, Klungel, Olaf H, Laurikka, Jari O, Lehtimäki, Terho, Maitland-van der Zee, Anke H, McPherson, Ruth, Palmer, Colin N, Kraaijeveld, Adriaan O, Pepine, Carl J, Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A, Stewart, Alexandre F R, Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L J, Waltenberger, Johannes, Richards, A Mark, Lang, Chim C, Cameron, Vicky A, Åkerblom, Axel, Pare, Guillaume, März, Winfried, Samani, Nilesh J, Hingorani, Aroon D, Ten Berg, Jurriën M, Wallentin, Lars, Asselbergs, Folkert W, Patel, Riyaz S, Onderzoek Precision medicine, Circulatory Health, CDL Onderzoek Pasterkamp, Cardiovasculaire Epidemiologie, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Global Health, CDL Arcadia, JC onderzoeksprogramma Methodologie, Team Medisch, Interne Geneeskunde Vasculaire, Mahmoodi, Bakhtawar K, Tragante, Vinicius, Kleber, Marcus E, Holmes, Michael V, Schmidt, Amand F, McCubrey, Raymond O, Howe, Laurence J, Direk, Kenan, Allayee, Hooman, Baranova, Ekaterina V, Braund, Peter S, Delgado, Graciela E, Eriksson, Niclas, Gijsberts, Crystel M, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Pasterkamp, Gerard, Kotti, Salma, Kuukasjärvi, Pekka, Lenzini, Petra A, Levin, Daniel, Lyytikäinen, Leo-Pekka, Muehlschlegel, Jochen D, Nelson, Christopher P, Nikus, Kjell, Pilbrow, Anna P, Wilson Tang, W H, van der Laan, Sander W, van Setten, Jessica, Vilmundarson, Ragnar O, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, James, Stefan, Mordi, Ify R, Teren, Andrej, Bergmeijer, Thomas O, Body, Simon C, Bots, Michiel, Burkhardt, Ralph, Cooper-DeHoff, Rhonda M, Cresci, Sharon, Danchin, Nicolas, Doughty, Robert N, Grobbee, Diederick E, Hagström, Emil, Hazen, Stanley L, Held, Claes, Hoefer, Imo E, Hovingh, G Kees, Johnson, Julie A, Kaczor, Marcin P, Kähönen, Mika, Klungel, Olaf H, Laurikka, Jari O, Lehtimäki, Terho, Maitland-van der Zee, Anke H, McPherson, Ruth, Palmer, Colin N, Kraaijeveld, Adriaan O, Pepine, Carl J, Sanak, Marek, Sattar, Naveed, Scholz, Markus, Simon, Tabassome, Spertus, John A, Stewart, Alexandre F R, Szczeklik, Wojciech, Thiery, Joachim, Visseren, Frank L J, Waltenberger, Johannes, Richards, A Mark, Lang, Chim C, Cameron, Vicky A, Åkerblom, Axel, Pare, Guillaume, März, Winfried, Samani, Nilesh J, Hingorani, Aroon D, Ten Berg, Jurriën M, Wallentin, Lars, Asselbergs, Folkert W, and Patel, Riyaz S
Published: 2020

22. Subsequent Event Risk in Individuals With Established Coronary Heart Disease : Design and Rationale of the GENIUS-CHD Consortium

Author: Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., Asselbergs, Folkert W., Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., and Asselbergs, Folkert W.
Abstract: BACKGROUND: The Genetics of Subsequent Coronary Heart Disease (GENIUS-CHD) consortium was established to facilitate discovery and validation of genetic variants and biomarkers for risk of subsequent CHD events, in individuals with established CHD. METHODS: The consortium currently includes 57 studies from 18 countries, recruiting 185 614 participants with either acute coronary syndrome, stable CHD, or a mixture of both at baseline. All studies collected biological samples and followed-up study participants prospectively for subsequent events. RESULTS: Enrollment into the individual studies took place between 1985 to present day with a duration of follow-up ranging from 9 months to 15 years. Within each study, participants with CHD are predominantly of self-reported European descent (38%-100%), mostly male (44%-91%) with mean ages at recruitment ranging from 40 to 75 years. Initial feasibility analyses, using a federated analysis approach, yielded expected associations between age (hazard ratio, 1.15; 95% CI, 1.14-1.16) per 5-year increase, male sex (hazard ratio, 1.17; 95% CI, 1.13-1.21) and smoking (hazard ratio, 1.43; 95% CI, 1.35-1.51) with risk of subsequent CHD death or myocardial infarction and differing associations with other individual and composite cardiovascular endpoints. CONCLUSIONS: GENIUS-CHD is a global collaboration seeking to elucidate genetic and nongenetic determinants of subsequent event risk in individuals with established CHD, to improve residual risk prediction and identify novel drug targets for secondary prevention. Initial analyses demonstrate the feasibility and reliability of a federated analysis approach. The consortium now plans to initiate and test novel hypotheses as well as supporting replication and validation analyses for other investigators.
Published: 2019
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23. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study

Author: Bhatt, Deepak L., Fox, Kim, Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Ridderstrale, Wilhelm, Held, Claes, Steg, Philippe Gabriel, Steg, Gabriel, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter, Nicolau, Jose Carlos, Kerr Saraiva, Jose Francisco, Petrov, Ivo, Corbalan, Ramon, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimsky, Petr, Kristensen, Steen Dalby, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Fat, Tse Hung, Kiss, Robert Gabor, Pais, Prem, Lev, Eli, De Luca, Leonardo, Goto, Shinya, Ramos Lopez, Gabriel Arturo, Cornel, Jan Hein, Kontny, Frederic, Medina, Felix, Babilonia, Noe, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry, Ruda, Mikhail, Elamin, Omer, Kovar, Frantisek, Dalby, Anthony John, Jeong, Myung Ho, Bueno, Hector, James, Stefan, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik, Parkhomenko, Alexander, McGuire, Darren, Kosiborod, Mikhail, Nguyen, Tuan Quang, Wallentin, Lars, Fox, Keith A. A., Eikelboom, John W., Tuomilehto, Jaakko, Lee, Kerry L., Al-Khalidi, Hussein R., Ellis, Stephen J., Hagström, Emil, Holmgren, Pernilla, Heldestad, Ulrika, Hallberg, Theresa, Renlund Grausne, Karin, Alm, Cristina, Michelgård Palmquist, Åsa, Svanberg, Camilla, Capell, Warren H., Nehler, Mark R., Hiatt, William R., Bonaca, Marc P., Houser, Stacey, Bachler, Susie, Jaeger, Nicole, Aunes, Maria, Brusehed, Asa, Chen, Jersey, Dahlof, Bjorn, Dolezalova, Jitka, Domzol, Maciej, Findley, Magdalena, Holmberg, Niclas, Jahreskog, Marianne, Knutsson, Mikael, Kruszewski, Jakub, Leonsson-Zachrisson, Maria, Stark, Maj, Winder, Elin, Bhatt, Deepak L., Fox, Kim, Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Ridderstrale, Wilhelm, Held, Claes, Steg, Philippe Gabriel, Steg, Gabriel, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter, Nicolau, Jose Carlos, Kerr Saraiva, Jose Francisco, Petrov, Ivo, Corbalan, Ramon, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimsky, Petr, Kristensen, Steen Dalby, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Fat, Tse Hung, Kiss, Robert Gabor, Pais, Prem, Lev, Eli, De Luca, Leonardo, Goto, Shinya, Ramos Lopez, Gabriel Arturo, Cornel, Jan Hein, Kontny, Frederic, Medina, Felix, Babilonia, Noe, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry, Ruda, Mikhail, Elamin, Omer, Kovar, Frantisek, Dalby, Anthony John, Jeong, Myung Ho, Bueno, Hector, James, Stefan, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik, Parkhomenko, Alexander, McGuire, Darren, Kosiborod, Mikhail, Nguyen, Tuan Quang, Wallentin, Lars, Fox, Keith A. A., Eikelboom, John W., Tuomilehto, Jaakko, Lee, Kerry L., Al-Khalidi, Hussein R., Ellis, Stephen J., Hagström, Emil, Holmgren, Pernilla, Heldestad, Ulrika, Hallberg, Theresa, Renlund Grausne, Karin, Alm, Cristina, Michelgård Palmquist, Åsa, Svanberg, Camilla, Capell, Warren H., Nehler, Mark R., Hiatt, William R., Bonaca, Marc P., Houser, Stacey, Bachler, Susie, Jaeger, Nicole, Aunes, Maria, Brusehed, Asa, Chen, Jersey, Dahlof, Bjorn, Dolezalova, Jitka, Domzol, Maciej, Findley, Magdalena, Holmberg, Niclas, Jahreskog, Marianne, Knutsson, Mikael, Kruszewski, Jakub, Leonsson-Zachrisson, Maria, Stark, Maj, and Winder, Elin
Abstract: In the setting of prior myocardial infarction, the oral antiplatelet ticagrelor added to aspirin reduced the risk of recurrent ischemic events, especially, in those with diabetes mellitus. Patients with stable coronary disease and diabetes are also at elevated risk and might benefit from dual antiplatelet therapy. The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS, NCT01991795) is a Phase 3b randomized, double-blinded, placebo-controlled trial of ticagrelor vs placebo, on top of low dose aspirin. Patients >= 50 years with type 2 diabetes receiving anti-diabetic medications for at least 6 months with stable coronary artery disease as determined by a history of previous percutaneous coronary intervention, bypass grafting, or angiographic stenosis of >= 50% of at least one coronary artery were enrolled. Patients with known prior myocardial infarction (MI) or stroke were excluded. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety endpoint is Thrombolysis in Myocardial Infarction major bleeding. A total of 19 220 patients worldwide have been randomized and at least 1385 adjudicated primary efficacy endpoint events are expected to be available for analysis, with an expected average follow-up of 40 months (maximum 58 months). Most of the exposure is on a 60 mg twice daily dose, as the dose was lowered from 90 mg twice daily partway into the study. The results may revise the boundaries of efficacy for dual antiplatelet therapy and whether it has a role outside acute coronary syndromes, prior myocardial infarction, or percutaneous coronary intervention.
Published: 2019
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24. Subsequent Event Risk in Individuals With Established Coronary Heart Disease : Design and Rationale of the GENIUS-CHD Consortium

Author: Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., Asselbergs, Folkert W., Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., and Asselbergs, Folkert W.
Abstract: BACKGROUND: The Genetics of Subsequent Coronary Heart Disease (GENIUS-CHD) consortium was established to facilitate discovery and validation of genetic variants and biomarkers for risk of subsequent CHD events, in individuals with established CHD. METHODS: The consortium currently includes 57 studies from 18 countries, recruiting 185 614 participants with either acute coronary syndrome, stable CHD, or a mixture of both at baseline. All studies collected biological samples and followed-up study participants prospectively for subsequent events. RESULTS: Enrollment into the individual studies took place between 1985 to present day with a duration of follow-up ranging from 9 months to 15 years. Within each study, participants with CHD are predominantly of self-reported European descent (38%-100%), mostly male (44%-91%) with mean ages at recruitment ranging from 40 to 75 years. Initial feasibility analyses, using a federated analysis approach, yielded expected associations between age (hazard ratio, 1.15; 95% CI, 1.14-1.16) per 5-year increase, male sex (hazard ratio, 1.17; 95% CI, 1.13-1.21) and smoking (hazard ratio, 1.43; 95% CI, 1.35-1.51) with risk of subsequent CHD death or myocardial infarction and differing associations with other individual and composite cardiovascular endpoints. CONCLUSIONS: GENIUS-CHD is a global collaboration seeking to elucidate genetic and nongenetic determinants of subsequent event risk in individuals with established CHD, to improve residual risk prediction and identify novel drug targets for secondary prevention. Initial analyses demonstrate the feasibility and reliability of a federated analysis approach. The consortium now plans to initiate and test novel hypotheses as well as supporting replication and validation analyses for other investigators.
Published: 2019
Full Text: View/download PDF

25. Subsequent Event Risk in Individuals With Established Coronary Heart Disease : Design and Rationale of the GENIUS-CHD Consortium

Author: Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., Asselbergs, Folkert W., Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., and Asselbergs, Folkert W.
Abstract: BACKGROUND: The Genetics of Subsequent Coronary Heart Disease (GENIUS-CHD) consortium was established to facilitate discovery and validation of genetic variants and biomarkers for risk of subsequent CHD events, in individuals with established CHD. METHODS: The consortium currently includes 57 studies from 18 countries, recruiting 185 614 participants with either acute coronary syndrome, stable CHD, or a mixture of both at baseline. All studies collected biological samples and followed-up study participants prospectively for subsequent events. RESULTS: Enrollment into the individual studies took place between 1985 to present day with a duration of follow-up ranging from 9 months to 15 years. Within each study, participants with CHD are predominantly of self-reported European descent (38%-100%), mostly male (44%-91%) with mean ages at recruitment ranging from 40 to 75 years. Initial feasibility analyses, using a federated analysis approach, yielded expected associations between age (hazard ratio, 1.15; 95% CI, 1.14-1.16) per 5-year increase, male sex (hazard ratio, 1.17; 95% CI, 1.13-1.21) and smoking (hazard ratio, 1.43; 95% CI, 1.35-1.51) with risk of subsequent CHD death or myocardial infarction and differing associations with other individual and composite cardiovascular endpoints. CONCLUSIONS: GENIUS-CHD is a global collaboration seeking to elucidate genetic and nongenetic determinants of subsequent event risk in individuals with established CHD, to improve residual risk prediction and identify novel drug targets for secondary prevention. Initial analyses demonstrate the feasibility and reliability of a federated analysis approach. The consortium now plans to initiate and test novel hypotheses as well as supporting replication and validation analyses for other investigators.
Published: 2019
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26. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study

Author: Bhatt, Deepak L., Fox, Kim, Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Ridderstrale, Wilhelm, Held, Claes, Steg, Philippe Gabriel, Steg, Gabriel, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter, Nicolau, Jose Carlos, Kerr Saraiva, Jose Francisco, Petrov, Ivo, Corbalan, Ramon, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimsky, Petr, Kristensen, Steen Dalby, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Fat, Tse Hung, Kiss, Robert Gabor, Pais, Prem, Lev, Eli, De Luca, Leonardo, Goto, Shinya, Ramos Lopez, Gabriel Arturo, Cornel, Jan Hein, Kontny, Frederic, Medina, Felix, Babilonia, Noe, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry, Ruda, Mikhail, Elamin, Omer, Kovar, Frantisek, Dalby, Anthony John, Jeong, Myung Ho, Bueno, Hector, James, Stefan, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik, Parkhomenko, Alexander, McGuire, Darren, Kosiborod, Mikhail, Nguyen, Tuan Quang, Wallentin, Lars, Fox, Keith A. A., Eikelboom, John W., Tuomilehto, Jaakko, Lee, Kerry L., Al-Khalidi, Hussein R., Ellis, Stephen J., Hagström, Emil, Holmgren, Pernilla, Heldestad, Ulrika, Hallberg, Theresa, Renlund Grausne, Karin, Alm, Cristina, Michelgård Palmquist, Åsa, Svanberg, Camilla, Capell, Warren H., Nehler, Mark R., Hiatt, William R., Bonaca, Marc P., Houser, Stacey, Bachler, Susie, Jaeger, Nicole, Aunes, Maria, Brusehed, Asa, Chen, Jersey, Dahlof, Bjorn, Dolezalova, Jitka, Domzol, Maciej, Findley, Magdalena, Holmberg, Niclas, Jahreskog, Marianne, Knutsson, Mikael, Kruszewski, Jakub, Leonsson-Zachrisson, Maria, Stark, Maj, Winder, Elin, Bhatt, Deepak L., Fox, Kim, Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Ridderstrale, Wilhelm, Held, Claes, Steg, Philippe Gabriel, Steg, Gabriel, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter, Nicolau, Jose Carlos, Kerr Saraiva, Jose Francisco, Petrov, Ivo, Corbalan, Ramon, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimsky, Petr, Kristensen, Steen Dalby, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Fat, Tse Hung, Kiss, Robert Gabor, Pais, Prem, Lev, Eli, De Luca, Leonardo, Goto, Shinya, Ramos Lopez, Gabriel Arturo, Cornel, Jan Hein, Kontny, Frederic, Medina, Felix, Babilonia, Noe, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry, Ruda, Mikhail, Elamin, Omer, Kovar, Frantisek, Dalby, Anthony John, Jeong, Myung Ho, Bueno, Hector, James, Stefan, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik, Parkhomenko, Alexander, McGuire, Darren, Kosiborod, Mikhail, Nguyen, Tuan Quang, Wallentin, Lars, Fox, Keith A. A., Eikelboom, John W., Tuomilehto, Jaakko, Lee, Kerry L., Al-Khalidi, Hussein R., Ellis, Stephen J., Hagström, Emil, Holmgren, Pernilla, Heldestad, Ulrika, Hallberg, Theresa, Renlund Grausne, Karin, Alm, Cristina, Michelgård Palmquist, Åsa, Svanberg, Camilla, Capell, Warren H., Nehler, Mark R., Hiatt, William R., Bonaca, Marc P., Houser, Stacey, Bachler, Susie, Jaeger, Nicole, Aunes, Maria, Brusehed, Asa, Chen, Jersey, Dahlof, Bjorn, Dolezalova, Jitka, Domzol, Maciej, Findley, Magdalena, Holmberg, Niclas, Jahreskog, Marianne, Knutsson, Mikael, Kruszewski, Jakub, Leonsson-Zachrisson, Maria, Stark, Maj, and Winder, Elin
Abstract: In the setting of prior myocardial infarction, the oral antiplatelet ticagrelor added to aspirin reduced the risk of recurrent ischemic events, especially, in those with diabetes mellitus. Patients with stable coronary disease and diabetes are also at elevated risk and might benefit from dual antiplatelet therapy. The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS, NCT01991795) is a Phase 3b randomized, double-blinded, placebo-controlled trial of ticagrelor vs placebo, on top of low dose aspirin. Patients >= 50 years with type 2 diabetes receiving anti-diabetic medications for at least 6 months with stable coronary artery disease as determined by a history of previous percutaneous coronary intervention, bypass grafting, or angiographic stenosis of >= 50% of at least one coronary artery were enrolled. Patients with known prior myocardial infarction (MI) or stroke were excluded. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety endpoint is Thrombolysis in Myocardial Infarction major bleeding. A total of 19 220 patients worldwide have been randomized and at least 1385 adjudicated primary efficacy endpoint events are expected to be available for analysis, with an expected average follow-up of 40 months (maximum 58 months). Most of the exposure is on a 60 mg twice daily dose, as the dose was lowered from 90 mg twice daily partway into the study. The results may revise the boundaries of efficacy for dual antiplatelet therapy and whether it has a role outside acute coronary syndromes, prior myocardial infarction, or percutaneous coronary intervention.
Published: 2019
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27. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study

Author: Bhatt, Deepak L., Fox, Kim, Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Ridderstrale, Wilhelm, Held, Claes, Steg, Philippe Gabriel, Steg, Gabriel, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter, Nicolau, Jose Carlos, Kerr Saraiva, Jose Francisco, Petrov, Ivo, Corbalan, Ramon, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimsky, Petr, Kristensen, Steen Dalby, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Fat, Tse Hung, Kiss, Robert Gabor, Pais, Prem, Lev, Eli, De Luca, Leonardo, Goto, Shinya, Ramos Lopez, Gabriel Arturo, Cornel, Jan Hein, Kontny, Frederic, Medina, Felix, Babilonia, Noe, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry, Ruda, Mikhail, Elamin, Omer, Kovar, Frantisek, Dalby, Anthony John, Jeong, Myung Ho, Bueno, Hector, James, Stefan, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik, Parkhomenko, Alexander, McGuire, Darren, Kosiborod, Mikhail, Nguyen, Tuan Quang, Wallentin, Lars, Fox, Keith A. A., Eikelboom, John W., Tuomilehto, Jaakko, Lee, Kerry L., Al-Khalidi, Hussein R., Ellis, Stephen J., Hagström, Emil, Holmgren, Pernilla, Heldestad, Ulrika, Hallberg, Theresa, Renlund Grausne, Karin, Alm, Cristina, Michelgård Palmquist, Åsa, Svanberg, Camilla, Capell, Warren H., Nehler, Mark R., Hiatt, William R., Bonaca, Marc P., Houser, Stacey, Bachler, Susie, Jaeger, Nicole, Aunes, Maria, Brusehed, Asa, Chen, Jersey, Dahlof, Bjorn, Dolezalova, Jitka, Domzol, Maciej, Findley, Magdalena, Holmberg, Niclas, Jahreskog, Marianne, Knutsson, Mikael, Kruszewski, Jakub, Leonsson-Zachrisson, Maria, Stark, Maj, Winder, Elin, Bhatt, Deepak L., Fox, Kim, Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Ridderstrale, Wilhelm, Held, Claes, Steg, Philippe Gabriel, Steg, Gabriel, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter, Nicolau, Jose Carlos, Kerr Saraiva, Jose Francisco, Petrov, Ivo, Corbalan, Ramon, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimsky, Petr, Kristensen, Steen Dalby, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Fat, Tse Hung, Kiss, Robert Gabor, Pais, Prem, Lev, Eli, De Luca, Leonardo, Goto, Shinya, Ramos Lopez, Gabriel Arturo, Cornel, Jan Hein, Kontny, Frederic, Medina, Felix, Babilonia, Noe, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry, Ruda, Mikhail, Elamin, Omer, Kovar, Frantisek, Dalby, Anthony John, Jeong, Myung Ho, Bueno, Hector, James, Stefan, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik, Parkhomenko, Alexander, McGuire, Darren, Kosiborod, Mikhail, Nguyen, Tuan Quang, Wallentin, Lars, Fox, Keith A. A., Eikelboom, John W., Tuomilehto, Jaakko, Lee, Kerry L., Al-Khalidi, Hussein R., Ellis, Stephen J., Hagström, Emil, Holmgren, Pernilla, Heldestad, Ulrika, Hallberg, Theresa, Renlund Grausne, Karin, Alm, Cristina, Michelgård Palmquist, Åsa, Svanberg, Camilla, Capell, Warren H., Nehler, Mark R., Hiatt, William R., Bonaca, Marc P., Houser, Stacey, Bachler, Susie, Jaeger, Nicole, Aunes, Maria, Brusehed, Asa, Chen, Jersey, Dahlof, Bjorn, Dolezalova, Jitka, Domzol, Maciej, Findley, Magdalena, Holmberg, Niclas, Jahreskog, Marianne, Knutsson, Mikael, Kruszewski, Jakub, Leonsson-Zachrisson, Maria, Stark, Maj, and Winder, Elin
Abstract: In the setting of prior myocardial infarction, the oral antiplatelet ticagrelor added to aspirin reduced the risk of recurrent ischemic events, especially, in those with diabetes mellitus. Patients with stable coronary disease and diabetes are also at elevated risk and might benefit from dual antiplatelet therapy. The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS, NCT01991795) is a Phase 3b randomized, double-blinded, placebo-controlled trial of ticagrelor vs placebo, on top of low dose aspirin. Patients >= 50 years with type 2 diabetes receiving anti-diabetic medications for at least 6 months with stable coronary artery disease as determined by a history of previous percutaneous coronary intervention, bypass grafting, or angiographic stenosis of >= 50% of at least one coronary artery were enrolled. Patients with known prior myocardial infarction (MI) or stroke were excluded. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety endpoint is Thrombolysis in Myocardial Infarction major bleeding. A total of 19 220 patients worldwide have been randomized and at least 1385 adjudicated primary efficacy endpoint events are expected to be available for analysis, with an expected average follow-up of 40 months (maximum 58 months). Most of the exposure is on a 60 mg twice daily dose, as the dose was lowered from 90 mg twice daily partway into the study. The results may revise the boundaries of efficacy for dual antiplatelet therapy and whether it has a role outside acute coronary syndromes, prior myocardial infarction, or percutaneous coronary intervention.
Published: 2019
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28. Subsequent Event Risk in Individuals with Established Coronary Heart Disease : Design and Rationale of the GENIUS-CHD Consortium

Author: Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael V., Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V., Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Graciela, Duarte, Nubia E., Dubé, Marie Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan V., Tanck, Michael W.T., Tang, W. H.Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrøm, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A.M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A.A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F.R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean Claude, Ten Berg, Jurriën M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L.J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., März, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., Asselbergs, Folkert W., Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael V., Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V., Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Graciela, Duarte, Nubia E., Dubé, Marie Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan V., Tanck, Michael W.T., Tang, W. H.Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrøm, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A.M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A.A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F.R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean Claude, Ten Berg, Jurriën M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L.J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., März, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., and Asselbergs, Folkert W.
Published: 2019

29. Association of Hearing Impairment with Incident Depressive Symptoms: A Community-Based Prospective Study

Author: Lisan, Quentin, Lisan, Quentin, van Sloten, Thomas T., Lemogne, Cedric, Offredo, Lucille, Climie, Rachel E., Boutouyrie, Pierre, Guibout, Catherine, Thomas, Frederique, Danchin, Nicolas, Jouven, Xavier, Empana, Jen-Philippe, Lisan, Quentin, Lisan, Quentin, van Sloten, Thomas T., Lemogne, Cedric, Offredo, Lucille, Climie, Rachel E., Boutouyrie, Pierre, Guibout, Catherine, Thomas, Frederique, Danchin, Nicolas, Jouven, Xavier, and Empana, Jen-Philippe
Abstract: OBJECTIVE: The aim was to investigate the potential association between hearing impairment and incident depressive symptoms.METHODS: Using a prospective community-based cohort study in France (the Paris Prospective Study III), participants aged 50-75 years were recruited between 2008 and 2012 and thereafter followed up every 2 years up to 2018. Hearing impairment, measured at study recruitment by audiometry testing, was defined as a pure tone average >25 decibels in the better ear. Incident depressive symptoms, measured using the validated 13-item Questionnaire of Depression 2nd version, was assessed during follow-up. Multivariate generalized estimating equations were used to compute odds ratio (OR) and 95% confidence intervals (CI).RESULTS: Among 7591 participants free of depressive symptoms at baseline (mean age 59.8 years, 63% of men), 14.3% had hearing impairment. Over 6 years of follow-up, 479 subjects (6.3%) had incident depressive symptoms. The OR for incident depressive symptoms was 1.36 for subjects with baseline hearing impairment (95% CI, 1.06-1.73). A pooled analysis of 4 published prospective studies yielded a multivariable relative risk of baseline hearing impairment for incident depressive symptoms of 1.29 (95% CI, 1.09-1.53).CONCLUSIONS: In this community-based prospective cohort study of participants aged 50 to 75 years, baseline hearing impairment was associated with a 36% increased odds of incident depressive symptoms. (C) 2019 Elsevier Inc. All rights reserved.
Published: 2019

30. Cardiovascular health and sleep disturbances in two population-based cohort studies

Author: Hausler, Nadine, Hausler, Nadine, Lisan, Quentin, Van Sloten, Thomas, Haba-Rubio, Jose, Perier, Marie-Cecile, Thomas, Frederique, Danchin, Nicolas, Guibout, Catherine, Boutouyrie, Pierre, Heinzer, Raphael, Jouven, Xavier, Marques-Vidal, Pedro, Empana, Jean-Philippe, Hausler, Nadine, Hausler, Nadine, Lisan, Quentin, Van Sloten, Thomas, Haba-Rubio, Jose, Perier, Marie-Cecile, Thomas, Frederique, Danchin, Nicolas, Guibout, Catherine, Boutouyrie, Pierre, Heinzer, Raphael, Jouven, Xavier, Marques-Vidal, Pedro, and Empana, Jean-Philippe
Abstract: Objective We aimed to investigate the association between cardiovascular health (CVH), as defined by the American Heart Association, and several sleep disturbances. Methods Two community-based cohorts, the Paris Prospective Study 3 (PPS3, France, n=6441) and the CoLaus study (Switzerland, n=2989) were analysed. CVH includes 7 metrics which all can be classified as poor, intermediate and ideal. Global CVH score was categorised into poor (0-2 ideal metrics), intermediate (3-4 ideal metrics) and ideal (>= 5 ideal metrics). Associations between global CVH and self-reported sleep disturbances (proxy of sleep-disordered breathing [SDB], excessive daytime sleepiness, insomnia symptoms and short/long sleep duration) and SDB severity measured by polysomnography (PSG) were investigated. Adjusted OR/relative risk ratio (RRR) and 95% CIs were estimated. Subjects with previous cardiovascular disease were excluded. Results Compared with poor CVH, subjects with intermediate and ideal global CVH had lower odds of self-reported SDB in both cohorts (ORs 0.55; 95% CI 0.44 to 0.68 and 0.35; 95% CI 0.22 to 0.53, respectively) and had lower SDB severity measured by PSG (RRR 0.07; 95% CI 0.02 to 0.20) in CoLaus. Subjects with intermediate and ideal global CVH had lower odds of excessive daytime sleepiness in PPS3 (ORs 0.82; 0.72 to 0.95 and 0.80; 0.82 to 1.02, respectively). No consistent associations were found between CVH and sleep duration or insomnia symptoms. Conclusions Higher levels of CVH are associated with lower odds of SDB and excessive daytime sleepiness. However, causal interpretation cannot be made and associations might be bidirectional.
Published: 2019

31. Individual and Neighborhood Deprivation and Carotid Stiffness: The Paris Prospective Study III

Author: Climie, Rachel E., Climie, Rachel E., Boutouyrie, Pierre, Perier, Marie-Cecile, Guibout, Catherine, van Sloten, Thomas T., Thomas, Frederique, Danchin, Nicolas, Sharman, James E., Laurent, Stephane, Jouven, Xavier, Empana, Jean-Philippe, Climie, Rachel E., Climie, Rachel E., Boutouyrie, Pierre, Perier, Marie-Cecile, Guibout, Catherine, van Sloten, Thomas T., Thomas, Frederique, Danchin, Nicolas, Sharman, James E., Laurent, Stephane, Jouven, Xavier, and Empana, Jean-Philippe
Abstract: Large artery stiffness is an index of vascular aging associated with cardiovascular mortality. Whereas traditional risk factors for arterial stiffness are known, the contribution of socioeconomic factors is less reported. We sought to determine the relationship between arterial stiffness and socioeconomic deprivation (at the individual and neighborhood levels) in healthy males and females. In 7803 adults, carotid stiffness was determined by high-precision carotid echo-tracking. Individual deprivation data included education, living alone, occupation, and Evaluation of the Deprivation and Inequalities of Health in Healthcare Centers score. Neighborhood deprivation was determined from commune level data (smallest administrative subdivision) available from French National Institute of Statistics and Economic Studies (2011) using principal component analysis. The separate and combined associations between individual and neighborhood deprivation (main exposures) and carotid stiffness (outcome) were quantified using linear and multilevel model adjusted for traditional risk factors. Analyses were conducted separately in males and females. Individual deprivation (lower education and occupation in males and living alone and higher Evaluation of the Deprivation and Inequalities of Health in Healthcare Centers in both populations) was adversely related to carotid stiffness, independently of potential confounders (P
Published: 2019

32. Subsequent Event Risk in Individuals with Established Coronary Heart Disease : Design and Rationale of the GENIUS-CHD Consortium

Author: Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael V., Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V., Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Graciela, Duarte, Nubia E., Dubé, Marie Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan V., Tanck, Michael W.T., Tang, W. H.Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrøm, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A.M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A.A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F.R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean Claude, Ten Berg, Jurriën M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L.J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., März, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., Asselbergs, Folkert W., Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael V., Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V., Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Graciela, Duarte, Nubia E., Dubé, Marie Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan V., Tanck, Michael W.T., Tang, W. H.Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrøm, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A.M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A.A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F.R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean Claude, Ten Berg, Jurriën M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L.J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., März, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., and Asselbergs, Folkert W.
Published: 2019

33. Subsequent Event Risk in Individuals With Established Coronary Heart Disease : Design and Rationale of the GENIUS-CHD Consortium

Author: Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., Asselbergs, Folkert W., Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., and Asselbergs, Folkert W.
Abstract: BACKGROUND: The Genetics of Subsequent Coronary Heart Disease (GENIUS-CHD) consortium was established to facilitate discovery and validation of genetic variants and biomarkers for risk of subsequent CHD events, in individuals with established CHD. METHODS: The consortium currently includes 57 studies from 18 countries, recruiting 185 614 participants with either acute coronary syndrome, stable CHD, or a mixture of both at baseline. All studies collected biological samples and followed-up study participants prospectively for subsequent events. RESULTS: Enrollment into the individual studies took place between 1985 to present day with a duration of follow-up ranging from 9 months to 15 years. Within each study, participants with CHD are predominantly of self-reported European descent (38%-100%), mostly male (44%-91%) with mean ages at recruitment ranging from 40 to 75 years. Initial feasibility analyses, using a federated analysis approach, yielded expected associations between age (hazard ratio, 1.15; 95% CI, 1.14-1.16) per 5-year increase, male sex (hazard ratio, 1.17; 95% CI, 1.13-1.21) and smoking (hazard ratio, 1.43; 95% CI, 1.35-1.51) with risk of subsequent CHD death or myocardial infarction and differing associations with other individual and composite cardiovascular endpoints. CONCLUSIONS: GENIUS-CHD is a global collaboration seeking to elucidate genetic and nongenetic determinants of subsequent event risk in individuals with established CHD, to improve residual risk prediction and identify novel drug targets for secondary prevention. Initial analyses demonstrate the feasibility and reliability of a federated analysis approach. The consortium now plans to initiate and test novel hypotheses as well as supporting replication and validation analyses for other investigators.
Published: 2019
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34. Subsequent Event Risk in Individuals with Established Coronary Heart Disease : Design and Rationale of the GENIUS-CHD Consortium

Author: Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael V., Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V., Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Graciela, Duarte, Nubia E., Dubé, Marie Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan V., Tanck, Michael W.T., Tang, W. H.Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrøm, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A.M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A.A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F.R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean Claude, Ten Berg, Jurriën M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L.J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., März, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., Asselbergs, Folkert W., Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael V., Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V., Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Graciela, Duarte, Nubia E., Dubé, Marie Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan V., Tanck, Michael W.T., Tang, W. H.Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrøm, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A.M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A.A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F.R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean Claude, Ten Berg, Jurriën M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L.J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., März, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., and Asselbergs, Folkert W.
Published: 2019

35. Subsequent Event Risk in Individuals With Established Coronary Heart Disease : Design and Rationale of the GENIUS-CHD Consortium

Author: Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., Asselbergs, Folkert W., Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., and Asselbergs, Folkert W.
Abstract: BACKGROUND: The Genetics of Subsequent Coronary Heart Disease (GENIUS-CHD) consortium was established to facilitate discovery and validation of genetic variants and biomarkers for risk of subsequent CHD events, in individuals with established CHD. METHODS: The consortium currently includes 57 studies from 18 countries, recruiting 185 614 participants with either acute coronary syndrome, stable CHD, or a mixture of both at baseline. All studies collected biological samples and followed-up study participants prospectively for subsequent events. RESULTS: Enrollment into the individual studies took place between 1985 to present day with a duration of follow-up ranging from 9 months to 15 years. Within each study, participants with CHD are predominantly of self-reported European descent (38%-100%), mostly male (44%-91%) with mean ages at recruitment ranging from 40 to 75 years. Initial feasibility analyses, using a federated analysis approach, yielded expected associations between age (hazard ratio, 1.15; 95% CI, 1.14-1.16) per 5-year increase, male sex (hazard ratio, 1.17; 95% CI, 1.13-1.21) and smoking (hazard ratio, 1.43; 95% CI, 1.35-1.51) with risk of subsequent CHD death or myocardial infarction and differing associations with other individual and composite cardiovascular endpoints. CONCLUSIONS: GENIUS-CHD is a global collaboration seeking to elucidate genetic and nongenetic determinants of subsequent event risk in individuals with established CHD, to improve residual risk prediction and identify novel drug targets for secondary prevention. Initial analyses demonstrate the feasibility and reliability of a federated analysis approach. The consortium now plans to initiate and test novel hypotheses as well as supporting replication and validation analyses for other investigators.
Published: 2019
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36. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study

Author: Bhatt, Deepak L., Fox, Kim, Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Ridderstrale, Wilhelm, Held, Claes, Steg, Philippe Gabriel, Steg, Gabriel, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter, Nicolau, Jose Carlos, Kerr Saraiva, Jose Francisco, Petrov, Ivo, Corbalan, Ramon, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimsky, Petr, Kristensen, Steen Dalby, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Fat, Tse Hung, Kiss, Robert Gabor, Pais, Prem, Lev, Eli, De Luca, Leonardo, Goto, Shinya, Ramos Lopez, Gabriel Arturo, Cornel, Jan Hein, Kontny, Frederic, Medina, Felix, Babilonia, Noe, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry, Ruda, Mikhail, Elamin, Omer, Kovar, Frantisek, Dalby, Anthony John, Jeong, Myung Ho, Bueno, Hector, James, Stefan, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik, Parkhomenko, Alexander, McGuire, Darren, Kosiborod, Mikhail, Nguyen, Tuan Quang, Wallentin, Lars, Fox, Keith A. A., Eikelboom, John W., Tuomilehto, Jaakko, Lee, Kerry L., Al-Khalidi, Hussein R., Ellis, Stephen J., Hagström, Emil, Holmgren, Pernilla, Heldestad, Ulrika, Hallberg, Theresa, Renlund Grausne, Karin, Alm, Cristina, Michelgård Palmquist, Åsa, Svanberg, Camilla, Capell, Warren H., Nehler, Mark R., Hiatt, William R., Bonaca, Marc P., Houser, Stacey, Bachler, Susie, Jaeger, Nicole, Aunes, Maria, Brusehed, Asa, Chen, Jersey, Dahlof, Bjorn, Dolezalova, Jitka, Domzol, Maciej, Findley, Magdalena, Holmberg, Niclas, Jahreskog, Marianne, Knutsson, Mikael, Kruszewski, Jakub, Leonsson-Zachrisson, Maria, Stark, Maj, Winder, Elin, Bhatt, Deepak L., Fox, Kim, Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Ridderstrale, Wilhelm, Held, Claes, Steg, Philippe Gabriel, Steg, Gabriel, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter, Nicolau, Jose Carlos, Kerr Saraiva, Jose Francisco, Petrov, Ivo, Corbalan, Ramon, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimsky, Petr, Kristensen, Steen Dalby, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Fat, Tse Hung, Kiss, Robert Gabor, Pais, Prem, Lev, Eli, De Luca, Leonardo, Goto, Shinya, Ramos Lopez, Gabriel Arturo, Cornel, Jan Hein, Kontny, Frederic, Medina, Felix, Babilonia, Noe, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry, Ruda, Mikhail, Elamin, Omer, Kovar, Frantisek, Dalby, Anthony John, Jeong, Myung Ho, Bueno, Hector, James, Stefan, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik, Parkhomenko, Alexander, McGuire, Darren, Kosiborod, Mikhail, Nguyen, Tuan Quang, Wallentin, Lars, Fox, Keith A. A., Eikelboom, John W., Tuomilehto, Jaakko, Lee, Kerry L., Al-Khalidi, Hussein R., Ellis, Stephen J., Hagström, Emil, Holmgren, Pernilla, Heldestad, Ulrika, Hallberg, Theresa, Renlund Grausne, Karin, Alm, Cristina, Michelgård Palmquist, Åsa, Svanberg, Camilla, Capell, Warren H., Nehler, Mark R., Hiatt, William R., Bonaca, Marc P., Houser, Stacey, Bachler, Susie, Jaeger, Nicole, Aunes, Maria, Brusehed, Asa, Chen, Jersey, Dahlof, Bjorn, Dolezalova, Jitka, Domzol, Maciej, Findley, Magdalena, Holmberg, Niclas, Jahreskog, Marianne, Knutsson, Mikael, Kruszewski, Jakub, Leonsson-Zachrisson, Maria, Stark, Maj, and Winder, Elin
Abstract: In the setting of prior myocardial infarction, the oral antiplatelet ticagrelor added to aspirin reduced the risk of recurrent ischemic events, especially, in those with diabetes mellitus. Patients with stable coronary disease and diabetes are also at elevated risk and might benefit from dual antiplatelet therapy. The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS, NCT01991795) is a Phase 3b randomized, double-blinded, placebo-controlled trial of ticagrelor vs placebo, on top of low dose aspirin. Patients >= 50 years with type 2 diabetes receiving anti-diabetic medications for at least 6 months with stable coronary artery disease as determined by a history of previous percutaneous coronary intervention, bypass grafting, or angiographic stenosis of >= 50% of at least one coronary artery were enrolled. Patients with known prior myocardial infarction (MI) or stroke were excluded. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety endpoint is Thrombolysis in Myocardial Infarction major bleeding. A total of 19 220 patients worldwide have been randomized and at least 1385 adjudicated primary efficacy endpoint events are expected to be available for analysis, with an expected average follow-up of 40 months (maximum 58 months). Most of the exposure is on a 60 mg twice daily dose, as the dose was lowered from 90 mg twice daily partway into the study. The results may revise the boundaries of efficacy for dual antiplatelet therapy and whether it has a role outside acute coronary syndromes, prior myocardial infarction, or percutaneous coronary intervention.
Published: 2019
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37. Subsequent Event Risk in Individuals with Established Coronary Heart Disease: Design and Rationale of the GENIUS-CHD Consortium

Author: Onderzoek Precision medicine, Circulatory Health, UMC Utrecht, Aios en Stafsecr. Cardiologie, Experimentele Afd. Cardiologie 1, Apotheek Klinische Farmacie Kinderen, CDL Onderzoek Pasterkamp, Cardiovasculaire Epi Team 6, ZL Cerebrovasculaire Ziekten Medisch, Brain, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Cardiovasculaire Epi Team 5, Cardiovasculaire Epi Team 9, CDL Arcadia, Global Health, JC onderzoeksprogramma Methodologie, dLAB Afdelingen, Device, Interne Geneeskunde Vasculaire, Team Medisch, Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael V., Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V., Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Graciela, Duarte, Nubia E., Dubé, Marie Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan V., Tanck, Michael W.T., Tang, W. H.Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrøm, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A.M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A.A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F.R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean Claude, Ten Berg, Jurriën M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L.J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., März, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., Asselbergs, Folkert W., Onderzoek Precision medicine, Circulatory Health, UMC Utrecht, Aios en Stafsecr. Cardiologie, Experimentele Afd. Cardiologie 1, Apotheek Klinische Farmacie Kinderen, CDL Onderzoek Pasterkamp, Cardiovasculaire Epi Team 6, ZL Cerebrovasculaire Ziekten Medisch, Brain, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Cardiovasculaire Epi Team 5, Cardiovasculaire Epi Team 9, CDL Arcadia, Global Health, JC onderzoeksprogramma Methodologie, dLAB Afdelingen, Device, Interne Geneeskunde Vasculaire, Team Medisch, Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael V., Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V., Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Graciela, Duarte, Nubia E., Dubé, Marie Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikäinen, Leo Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan V., Tanck, Michael W.T., Tang, W. H.Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrøm, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A.M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A.A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F.R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean Claude, Ten Berg, Jurriën M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L.J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., März, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., and Asselbergs, Folkert W.
Published: 2019

38. Association of Hearing Impairment with Incident Depressive Symptoms: A Community-Based Prospective Study

Author: Lisan, Quentin, van Sloten, Thomas T., Lemogne, Cedric, Offredo, Lucille, Climie, Rachel E., Boutouyrie, Pierre, Guibout, Catherine, Thomas, Frederique, Danchin, Nicolas, Jouven, Xavier, Empana, Jen-Philippe, Lisan, Quentin, van Sloten, Thomas T., Lemogne, Cedric, Offredo, Lucille, Climie, Rachel E., Boutouyrie, Pierre, Guibout, Catherine, Thomas, Frederique, Danchin, Nicolas, Jouven, Xavier, and Empana, Jen-Philippe
Abstract: OBJECTIVE: The aim was to investigate the potential association between hearing impairment and incident depressive symptoms.METHODS: Using a prospective community-based cohort study in France (the Paris Prospective Study III), participants aged 50-75 years were recruited between 2008 and 2012 and thereafter followed up every 2 years up to 2018. Hearing impairment, measured at study recruitment by audiometry testing, was defined as a pure tone average >25 decibels in the better ear. Incident depressive symptoms, measured using the validated 13-item Questionnaire of Depression 2nd version, was assessed during follow-up. Multivariate generalized estimating equations were used to compute odds ratio (OR) and 95% confidence intervals (CI).RESULTS: Among 7591 participants free of depressive symptoms at baseline (mean age 59.8 years, 63% of men), 14.3% had hearing impairment. Over 6 years of follow-up, 479 subjects (6.3%) had incident depressive symptoms. The OR for incident depressive symptoms was 1.36 for subjects with baseline hearing impairment (95% CI, 1.06-1.73). A pooled analysis of 4 published prospective studies yielded a multivariable relative risk of baseline hearing impairment for incident depressive symptoms of 1.29 (95% CI, 1.09-1.53).CONCLUSIONS: In this community-based prospective cohort study of participants aged 50 to 75 years, baseline hearing impairment was associated with a 36% increased odds of incident depressive symptoms. (C) 2019 Elsevier Inc. All rights reserved.
Published: 2019

39. Individual and Neighborhood Deprivation and Carotid Stiffness: The Paris Prospective Study III

Author: Climie, Rachel E., Boutouyrie, Pierre, Perier, Marie-Cecile, Guibout, Catherine, van Sloten, Thomas T., Thomas, Frederique, Danchin, Nicolas, Sharman, James E., Laurent, Stephane, Jouven, Xavier, Empana, Jean-Philippe, Climie, Rachel E., Boutouyrie, Pierre, Perier, Marie-Cecile, Guibout, Catherine, van Sloten, Thomas T., Thomas, Frederique, Danchin, Nicolas, Sharman, James E., Laurent, Stephane, Jouven, Xavier, and Empana, Jean-Philippe
Abstract: Large artery stiffness is an index of vascular aging associated with cardiovascular mortality. Whereas traditional risk factors for arterial stiffness are known, the contribution of socioeconomic factors is less reported. We sought to determine the relationship between arterial stiffness and socioeconomic deprivation (at the individual and neighborhood levels) in healthy males and females. In 7803 adults, carotid stiffness was determined by high-precision carotid echo-tracking. Individual deprivation data included education, living alone, occupation, and Evaluation of the Deprivation and Inequalities of Health in Healthcare Centers score. Neighborhood deprivation was determined from commune level data (smallest administrative subdivision) available from French National Institute of Statistics and Economic Studies (2011) using principal component analysis. The separate and combined associations between individual and neighborhood deprivation (main exposures) and carotid stiffness (outcome) were quantified using linear and multilevel model adjusted for traditional risk factors. Analyses were conducted separately in males and females. Individual deprivation (lower education and occupation in males and living alone and higher Evaluation of the Deprivation and Inequalities of Health in Healthcare Centers in both populations) was adversely related to carotid stiffness, independently of potential confounders (P
Published: 2019

40. Cardiovascular health and sleep disturbances in two population-based cohort studies

Author: Hausler, Nadine, Lisan, Quentin, Van Sloten, Thomas, Haba-Rubio, Jose, Perier, Marie-Cecile, Thomas, Frederique, Danchin, Nicolas, Guibout, Catherine, Boutouyrie, Pierre, Heinzer, Raphael, Jouven, Xavier, Marques-Vidal, Pedro, Empana, Jean-Philippe, Hausler, Nadine, Lisan, Quentin, Van Sloten, Thomas, Haba-Rubio, Jose, Perier, Marie-Cecile, Thomas, Frederique, Danchin, Nicolas, Guibout, Catherine, Boutouyrie, Pierre, Heinzer, Raphael, Jouven, Xavier, Marques-Vidal, Pedro, and Empana, Jean-Philippe
Abstract: Objective We aimed to investigate the association between cardiovascular health (CVH), as defined by the American Heart Association, and several sleep disturbances. Methods Two community-based cohorts, the Paris Prospective Study 3 (PPS3, France, n=6441) and the CoLaus study (Switzerland, n=2989) were analysed. CVH includes 7 metrics which all can be classified as poor, intermediate and ideal. Global CVH score was categorised into poor (0-2 ideal metrics), intermediate (3-4 ideal metrics) and ideal (>= 5 ideal metrics). Associations between global CVH and self-reported sleep disturbances (proxy of sleep-disordered breathing [SDB], excessive daytime sleepiness, insomnia symptoms and short/long sleep duration) and SDB severity measured by polysomnography (PSG) were investigated. Adjusted OR/relative risk ratio (RRR) and 95% CIs were estimated. Subjects with previous cardiovascular disease were excluded. Results Compared with poor CVH, subjects with intermediate and ideal global CVH had lower odds of self-reported SDB in both cohorts (ORs 0.55; 95% CI 0.44 to 0.68 and 0.35; 95% CI 0.22 to 0.53, respectively) and had lower SDB severity measured by PSG (RRR 0.07; 95% CI 0.02 to 0.20) in CoLaus. Subjects with intermediate and ideal global CVH had lower odds of excessive daytime sleepiness in PPS3 (ORs 0.82; 0.72 to 0.95 and 0.80; 0.82 to 1.02, respectively). No consistent associations were found between CVH and sleep duration or insomnia symptoms. Conclusions Higher levels of CVH are associated with lower odds of SDB and excessive daytime sleepiness. However, causal interpretation cannot be made and associations might be bidirectional.
Published: 2019

41. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study

Author: Bhatt, Deepak L., Fox, Kim, Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Ridderstrale, Wilhelm, Held, Claes, Steg, Philippe Gabriel, Steg, Gabriel, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter, Nicolau, Jose Carlos, Kerr Saraiva, Jose Francisco, Petrov, Ivo, Corbalan, Ramon, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimsky, Petr, Kristensen, Steen Dalby, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Fat, Tse Hung, Kiss, Robert Gabor, Pais, Prem, Lev, Eli, De Luca, Leonardo, Goto, Shinya, Ramos Lopez, Gabriel Arturo, Cornel, Jan Hein, Kontny, Frederic, Medina, Felix, Babilonia, Noe, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry, Ruda, Mikhail, Elamin, Omer, Kovar, Frantisek, Dalby, Anthony John, Jeong, Myung Ho, Bueno, Hector, James, Stefan, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik, Parkhomenko, Alexander, McGuire, Darren, Kosiborod, Mikhail, Nguyen, Tuan Quang, Wallentin, Lars, Fox, Keith A. A., Eikelboom, John W., Tuomilehto, Jaakko, Lee, Kerry L., Al-Khalidi, Hussein R., Ellis, Stephen J., Hagström, Emil, Holmgren, Pernilla, Heldestad, Ulrika, Hallberg, Theresa, Renlund Grausne, Karin, Alm, Cristina, Michelgård Palmquist, Åsa, Svanberg, Camilla, Capell, Warren H., Nehler, Mark R., Hiatt, William R., Bonaca, Marc P., Houser, Stacey, Bachler, Susie, Jaeger, Nicole, Aunes, Maria, Brusehed, Asa, Chen, Jersey, Dahlof, Bjorn, Dolezalova, Jitka, Domzol, Maciej, Findley, Magdalena, Holmberg, Niclas, Jahreskog, Marianne, Knutsson, Mikael, Kruszewski, Jakub, Leonsson-Zachrisson, Maria, Stark, Maj, Winder, Elin, Bhatt, Deepak L., Fox, Kim, Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Ridderstrale, Wilhelm, Held, Claes, Steg, Philippe Gabriel, Steg, Gabriel, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter, Nicolau, Jose Carlos, Kerr Saraiva, Jose Francisco, Petrov, Ivo, Corbalan, Ramon, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimsky, Petr, Kristensen, Steen Dalby, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Fat, Tse Hung, Kiss, Robert Gabor, Pais, Prem, Lev, Eli, De Luca, Leonardo, Goto, Shinya, Ramos Lopez, Gabriel Arturo, Cornel, Jan Hein, Kontny, Frederic, Medina, Felix, Babilonia, Noe, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry, Ruda, Mikhail, Elamin, Omer, Kovar, Frantisek, Dalby, Anthony John, Jeong, Myung Ho, Bueno, Hector, James, Stefan, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik, Parkhomenko, Alexander, McGuire, Darren, Kosiborod, Mikhail, Nguyen, Tuan Quang, Wallentin, Lars, Fox, Keith A. A., Eikelboom, John W., Tuomilehto, Jaakko, Lee, Kerry L., Al-Khalidi, Hussein R., Ellis, Stephen J., Hagström, Emil, Holmgren, Pernilla, Heldestad, Ulrika, Hallberg, Theresa, Renlund Grausne, Karin, Alm, Cristina, Michelgård Palmquist, Åsa, Svanberg, Camilla, Capell, Warren H., Nehler, Mark R., Hiatt, William R., Bonaca, Marc P., Houser, Stacey, Bachler, Susie, Jaeger, Nicole, Aunes, Maria, Brusehed, Asa, Chen, Jersey, Dahlof, Bjorn, Dolezalova, Jitka, Domzol, Maciej, Findley, Magdalena, Holmberg, Niclas, Jahreskog, Marianne, Knutsson, Mikael, Kruszewski, Jakub, Leonsson-Zachrisson, Maria, Stark, Maj, and Winder, Elin
Abstract: In the setting of prior myocardial infarction, the oral antiplatelet ticagrelor added to aspirin reduced the risk of recurrent ischemic events, especially, in those with diabetes mellitus. Patients with stable coronary disease and diabetes are also at elevated risk and might benefit from dual antiplatelet therapy. The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS, NCT01991795) is a Phase 3b randomized, double-blinded, placebo-controlled trial of ticagrelor vs placebo, on top of low dose aspirin. Patients >= 50 years with type 2 diabetes receiving anti-diabetic medications for at least 6 months with stable coronary artery disease as determined by a history of previous percutaneous coronary intervention, bypass grafting, or angiographic stenosis of >= 50% of at least one coronary artery were enrolled. Patients with known prior myocardial infarction (MI) or stroke were excluded. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety endpoint is Thrombolysis in Myocardial Infarction major bleeding. A total of 19 220 patients worldwide have been randomized and at least 1385 adjudicated primary efficacy endpoint events are expected to be available for analysis, with an expected average follow-up of 40 months (maximum 58 months). Most of the exposure is on a 60 mg twice daily dose, as the dose was lowered from 90 mg twice daily partway into the study. The results may revise the boundaries of efficacy for dual antiplatelet therapy and whether it has a role outside acute coronary syndromes, prior myocardial infarction, or percutaneous coronary intervention.
Published: 2019
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42. Subsequent Event Risk in Individuals with Established Coronary Heart Disease:Design and Rationale of the GENIUS-CHD Consortium

Author: Patel, Riyaz, Tragante, Vinicius, Schmidt, Amand F, McCubrey, Raymond O, Holmes, Michael V, Howe, Laurence J, Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S, Kaminski, Karol A, Muehlschlegel, Jochen D, Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V, Behlouli, Hassan, Boeckx, Bram, Braund, Peter S, Breitling, Lutz P, Delgado, Graciela, Duarte, Nubia E, Dubé, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M, Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A, Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A, Levin, Daniel, Lyytikäinen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P, Nikus, Kjell, Pilbrow, Anna P, Ploski, Rafal, Sun, Yan V, Tanck, Michael W T, Tang, W H Wilson, Trompet, Stella, van der Laan, Sander W, Van Setten, Jessica, Vilmundarson, Ragnar O, Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F, Carruthers, Kathryn F, Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engström, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A, Marziliano, Nicola, Mordi, Ify R, Muhlestein, Joseph B, Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H, Samman-Tahhan, Ayman, Sandesara, Pratik B, Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A M, Ford, Ian, Stott, David J, Algra, Ale, Andreassi, Maria G, Ardissino, Diego, Arsenault, Benoit J, Ballantyne, Christie M, Bergmeijer, Thomas O, Bezzina, Connie R, Body, Simon C, Boersma, Eric H, Bogaty, Peter, Bots, Michiel, Brenner, Hermann, Brugts, Jasper J, Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M, Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N, Drexel, Heinz, Engert, James C, Fox, Keith A A, Girelli, Domenico, Grobbee, Diederick E, Hagström, Emil, Hazen, Stanley L, Held, Claes, Hemingway, Harry, Hoefer, Imo E, Hovingh, G Kees, Jabbari, Reza, Johnson, Julie A, Jukema, J Wouter, Kaczor, Marcin P, Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H, Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O, Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B K, Maitland-van der Zee, Anke H, McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N, Pasterkamp, Gerard, Pepine, Carl J, Pereira, Alexandre C, Pilote, Louise, Quyyumi, Arshed A, Richards, A Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J Gustav, Spertus, John A, Stender, Steen, Stewart, Alexandre F R, Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, Ten Berg, Jurriën M, Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L J, Waltenberger, Johannes, Weeke, Peter E, Van der Harst, Pim, Lang, Chim C, Sattar, Naveed, Cameron, Vicky A, Anderson, Jeffrey L, Brophy, James M, Paré, Guillaume, Horne, Benjamin D, März, Winfried, Wallentin, Lars, Samani, Nilesh J, Hingorani, Aroon D, Asselbergs, Folkert W, Patel, Riyaz, Tragante, Vinicius, Schmidt, Amand F, McCubrey, Raymond O, Holmes, Michael V, Howe, Laurence J, Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S, Kaminski, Karol A, Muehlschlegel, Jochen D, Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V, Behlouli, Hassan, Boeckx, Bram, Braund, Peter S, Breitling, Lutz P, Delgado, Graciela, Duarte, Nubia E, Dubé, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M, Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A, Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A, Levin, Daniel, Lyytikäinen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P, Nikus, Kjell, Pilbrow, Anna P, Ploski, Rafal, Sun, Yan V, Tanck, Michael W T, Tang, W H Wilson, Trompet, Stella, van der Laan, Sander W, Van Setten, Jessica, Vilmundarson, Ragnar O, Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F, Carruthers, Kathryn F, Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engström, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A, Marziliano, Nicola, Mordi, Ify R, Muhlestein, Joseph B, Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H, Samman-Tahhan, Ayman, Sandesara, Pratik B, Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A M, Ford, Ian, Stott, David J, Algra, Ale, Andreassi, Maria G, Ardissino, Diego, Arsenault, Benoit J, Ballantyne, Christie M, Bergmeijer, Thomas O, Bezzina, Connie R, Body, Simon C, Boersma, Eric H, Bogaty, Peter, Bots, Michiel, Brenner, Hermann, Brugts, Jasper J, Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M, Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N, Drexel, Heinz, Engert, James C, Fox, Keith A A, Girelli, Domenico, Grobbee, Diederick E, Hagström, Emil, Hazen, Stanley L, Held, Claes, Hemingway, Harry, Hoefer, Imo E, Hovingh, G Kees, Jabbari, Reza, Johnson, Julie A, Jukema, J Wouter, Kaczor, Marcin P, Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H, Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O, Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B K, Maitland-van der Zee, Anke H, McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N, Pasterkamp, Gerard, Pepine, Carl J, Pereira, Alexandre C, Pilote, Louise, Quyyumi, Arshed A, Richards, A Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J Gustav, Spertus, John A, Stender, Steen, Stewart, Alexandre F R, Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, Ten Berg, Jurriën M, Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L J, Waltenberger, Johannes, Weeke, Peter E, Van der Harst, Pim, Lang, Chim C, Sattar, Naveed, Cameron, Vicky A, Anderson, Jeffrey L, Brophy, James M, Paré, Guillaume, Horne, Benjamin D, März, Winfried, Wallentin, Lars, Samani, Nilesh J, Hingorani, Aroon D, and Asselbergs, Folkert W
Abstract: BACKGROUND: The "GENetIcs of sUbSequent Coronary Heart Disease" (GENIUS-CHD) consortium was established to facilitate discovery and validation of genetic variants and biomarkers for risk of subsequent CHD events, in individuals with established CHD.METHODS: The consortium currently includes 57 studies from 18 countries, recruiting 185,614 participants with either acute coronary syndrome, stable CHD or a mixture of both at baseline. All studies collected biological samples and followed-up study participants prospectively for subsequent events.RESULTS: Enrollment into the individual studies took place between 1985 to present day with duration of follow up ranging from 9 months to 15 years. Within each study, participants with CHD are predominantly of self-reported European descent (38%-100%), mostly male (44%-91%) with mean ages at recruitment ranging from 40 to 75 years. Initial feasibility analyses, using a federated analysis approach, yielded expected associations between age (HR 1.15 95% CI 1.14-1.16) per 5-year increase, male sex (HR 1.17, 95% CI 1.13-1.21) and smoking (HR 1.43, 95% CI 1.35-1.51) with risk of subsequent CHD death or myocardial infarction, and differing associations with other individual and composite cardiovascular endpoints.CONCLUSIONS: GENIUS-CHD is a global collaboration seeking to elucidate genetic and non-genetic determinants of subsequent event risk in individuals with established CHD, in order to improve residual risk prediction and identify novel drug targets for secondary prevention. Initial analyses demonstrate the feasibility and reliability of a federated analysis approach. The consortium now plans to initiate and test novel hypotheses as well as supporting replication and validation analyses for other investigators.
Published: 2019

43. Subsequent Event Risk in Individuals With Established Coronary Heart Disease : Design and Rationale of the GENIUS-CHD Consortium

Author: Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., Asselbergs, Folkert W., Patel, Riyaz S., Tragante, Vinicius, Schmidt, Amand F., McCubrey, Raymond O., Holmes, Michael, V, Howe, Laurence J., Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S., Kaminski, Karol A., Muehlschlegel, Jochen D., Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina, V, Behloui, Hassan, Boeckx, Bram, Braund, Peter S., Breitling, Lutz P., Delgado, Gradela, Duarte, Nubia E., Dube, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M., Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A., Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjarvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lyytikainen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P., Nikus, Kjell, Pilbrow, Anna P., Ploski, Rafal, Sun, Yan, V, Tanck, Michael W. T., Tang, W. H. Wilson, Trompet, Stella, van der Laan, Sander W., Van Setten, Jessica, Vilmundarson, Ragnar O., Anselmi, Chiara Viviani, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F., Carruthers, Kathryn F., Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engstrom, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A., Marziliano, Nicola, Mordi, Ify R., Muhlestein, Joseph B., Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H., Samman-Tahhan, Ayman, Sandesara, Pratik B., Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A. M., Ford, Ian, Stott, David J., Algra, Ale, Andreassi, Maria G., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Bergmeijer, Thomas O., Bezzina, Connie R., Body, Simon C., Boersma, Eric H., Bogaty, Peter, Bots, Michiel L., Brenner, Hermann, Brugts, Jasper J., Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M., Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N., Drexel, Heinz, Engert, James C., Fox, Keith A. A., Girelli, Domenico, Grobbee, Diederick E., Hagström, Emil, Hazen, Stanley L., Held, Claes, Hemingway, Harry, Hoefer, Imo E., Hovingh, G. Kees, Jabbari, Reza, Johnson, Julie A., Jukema, J. Wouter, Kaczor, Marcin P., Kahonen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H., Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O., Lehtimaki, Terho, Lindholm, Daniel, Mahmoodi, B. K., Maitland-van der Zee, Anke H., McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pasterkamp, Gerard, Pepine, Carl J., Pereira, Alexandre C., Pilote, Louise, Quyyumi, Arshed A., Richards, A. Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J. Gustav, Spertus, John A., Stender, Steen, Stewart, Alexandre F. R., Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, ten Berg, Jurrien M., Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L. J., Waltenberger, Johannes, Weeke, Peter E., Van der Harst, Pim, Lang, Chim C., Sattar, Naveed, Cameron, Vicky A., Anderson, Jeffrey L., Brophy, James M., Pare, Guillaume, Horne, Benjamin D., Marz, Winfried, Wallentin, Lars, Samani, Nilesh J., Hingorani, Aroon D., and Asselbergs, Folkert W.
Abstract: BACKGROUND: The Genetics of Subsequent Coronary Heart Disease (GENIUS-CHD) consortium was established to facilitate discovery and validation of genetic variants and biomarkers for risk of subsequent CHD events, in individuals with established CHD. METHODS: The consortium currently includes 57 studies from 18 countries, recruiting 185 614 participants with either acute coronary syndrome, stable CHD, or a mixture of both at baseline. All studies collected biological samples and followed-up study participants prospectively for subsequent events. RESULTS: Enrollment into the individual studies took place between 1985 to present day with a duration of follow-up ranging from 9 months to 15 years. Within each study, participants with CHD are predominantly of self-reported European descent (38%-100%), mostly male (44%-91%) with mean ages at recruitment ranging from 40 to 75 years. Initial feasibility analyses, using a federated analysis approach, yielded expected associations between age (hazard ratio, 1.15; 95% CI, 1.14-1.16) per 5-year increase, male sex (hazard ratio, 1.17; 95% CI, 1.13-1.21) and smoking (hazard ratio, 1.43; 95% CI, 1.35-1.51) with risk of subsequent CHD death or myocardial infarction and differing associations with other individual and composite cardiovascular endpoints. CONCLUSIONS: GENIUS-CHD is a global collaboration seeking to elucidate genetic and nongenetic determinants of subsequent event risk in individuals with established CHD, to improve residual risk prediction and identify novel drug targets for secondary prevention. Initial analyses demonstrate the feasibility and reliability of a federated analysis approach. The consortium now plans to initiate and test novel hypotheses as well as supporting replication and validation analyses for other investigators.
Published: 2019
Full Text: View/download PDF

44. Subsequent Event Risk in Individuals with Established Coronary Heart Disease:Design and Rationale of the GENIUS-CHD Consortium

Author: Patel, Riyaz, Tragante, Vinicius, Schmidt, Amand F, McCubrey, Raymond O, Holmes, Michael V, Howe, Laurence J, Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S, Kaminski, Karol A, Muehlschlegel, Jochen D, Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V, Behlouli, Hassan, Boeckx, Bram, Braund, Peter S, Breitling, Lutz P, Delgado, Graciela, Duarte, Nubia E, Dubé, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M, Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A, Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A, Levin, Daniel, Lyytikäinen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P, Nikus, Kjell, Pilbrow, Anna P, Ploski, Rafal, Sun, Yan V, Tanck, Michael W T, Tang, W H Wilson, Trompet, Stella, van der Laan, Sander W, Van Setten, Jessica, Vilmundarson, Ragnar O, Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F, Carruthers, Kathryn F, Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engström, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A, Marziliano, Nicola, Mordi, Ify R, Muhlestein, Joseph B, Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H, Samman-Tahhan, Ayman, Sandesara, Pratik B, Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A M, Ford, Ian, Stott, David J, Algra, Ale, Andreassi, Maria G, Ardissino, Diego, Arsenault, Benoit J, Ballantyne, Christie M, Bergmeijer, Thomas O, Bezzina, Connie R, Body, Simon C, Boersma, Eric H, Bogaty, Peter, Bots, Michiel, Brenner, Hermann, Brugts, Jasper J, Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M, Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N, Drexel, Heinz, Engert, James C, Fox, Keith A A, Girelli, Domenico, Grobbee, Diederick E, Hagström, Emil, Hazen, Stanley L, Held, Claes, Hemingway, Harry, Hoefer, Imo E, Hovingh, G Kees, Jabbari, Reza, Johnson, Julie A, Jukema, J Wouter, Kaczor, Marcin P, Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H, Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O, Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B K, Maitland-van der Zee, Anke H, McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N, Pasterkamp, Gerard, Pepine, Carl J, Pereira, Alexandre C, Pilote, Louise, Quyyumi, Arshed A, Richards, A Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J Gustav, Spertus, John A, Stender, Steen, Stewart, Alexandre F R, Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, Ten Berg, Jurriën M, Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L J, Waltenberger, Johannes, Weeke, Peter E, Van der Harst, Pim, Lang, Chim C, Sattar, Naveed, Cameron, Vicky A, Anderson, Jeffrey L, Brophy, James M, Paré, Guillaume, Horne, Benjamin D, März, Winfried, Wallentin, Lars, Samani, Nilesh J, Hingorani, Aroon D, Asselbergs, Folkert W, Patel, Riyaz, Tragante, Vinicius, Schmidt, Amand F, McCubrey, Raymond O, Holmes, Michael V, Howe, Laurence J, Direk, Kenan, Åkerblom, Axel, Leander, Karin, Virani, Salim S, Kaminski, Karol A, Muehlschlegel, Jochen D, Allayee, Hooman, Almgren, Peter, Alver, Maris, Baranova, Ekaterina V, Behlouli, Hassan, Boeckx, Bram, Braund, Peter S, Breitling, Lutz P, Delgado, Graciela, Duarte, Nubia E, Dubé, Marie-Pierre, Dufresne, Line, Eriksson, Niclas, Foco, Luisa, Scholz, Markus, Gijsberts, Crystel M, Glinge, Charlotte, Gong, Yan, Hartiala, Jaana, Heydarpour, Mahyar, Hubacek, Jaroslav A, Kleber, Marcus, Kofink, Daniel, Kotti, Salma, Kuukasjärvi, Pekka, Lee, Vei-Vei, Leiherer, Andreas, Lenzini, Petra A, Levin, Daniel, Lyytikäinen, Leo-Pekka, Martinelli, Nicola, Mons, Ute, Nelson, Christopher P, Nikus, Kjell, Pilbrow, Anna P, Ploski, Rafal, Sun, Yan V, Tanck, Michael W T, Tang, W H Wilson, Trompet, Stella, van der Laan, Sander W, Van Setten, Jessica, Vilmundarson, Ragnar O, Viviani Anselmi, Chiara, Vlachopoulou, Efthymia, Al Ali, Lawien, Boerwinkle, Eric, Briguori, Carlo, Carlquist, John F, Carruthers, Kathryn F, Casu, Gavino, Deanfield, John, Deloukas, Panos, Dudbridge, Frank, Engström, Thomas, Fitzpatrick, Natalie, Fox, Kim, Gigante, Bruna, James, Stefan, Lokki, Marja-Liisa, Lotufo, Paulo A, Marziliano, Nicola, Mordi, Ify R, Muhlestein, Joseph B, Newton-Cheh, Christopher, Pitha, Jan, Saely, Christoph H, Samman-Tahhan, Ayman, Sandesara, Pratik B, Teren, Andrej, Timmis, Adam, Van de Werf, Frans, Wauters, Els, Wilde, Arthur A M, Ford, Ian, Stott, David J, Algra, Ale, Andreassi, Maria G, Ardissino, Diego, Arsenault, Benoit J, Ballantyne, Christie M, Bergmeijer, Thomas O, Bezzina, Connie R, Body, Simon C, Boersma, Eric H, Bogaty, Peter, Bots, Michiel, Brenner, Hermann, Brugts, Jasper J, Burkhardt, Ralph, Carpeggiani, Clara, Condorelli, Gianluigi, Cooper-DeHoff, Rhonda M, Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Doughty, Robert N, Drexel, Heinz, Engert, James C, Fox, Keith A A, Girelli, Domenico, Grobbee, Diederick E, Hagström, Emil, Hazen, Stanley L, Held, Claes, Hemingway, Harry, Hoefer, Imo E, Hovingh, G Kees, Jabbari, Reza, Johnson, Julie A, Jukema, J Wouter, Kaczor, Marcin P, Kähönen, Mika, Kettner, Jiri, Kiliszek, Marek, Klungel, Olaf H, Lagerqvist, Bo, Lambrechts, Diether, Laurikka, Jari O, Lehtimäki, Terho, Lindholm, Daniel, Mahmoodi, B K, Maitland-van der Zee, Anke H, McPherson, Ruth, Melander, Olle, Metspalu, Andres, Niemcunowicz-Janica, Anna, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N, Pasterkamp, Gerard, Pepine, Carl J, Pereira, Alexandre C, Pilote, Louise, Quyyumi, Arshed A, Richards, A Mark, Sanak, Marek, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Smith, J Gustav, Spertus, John A, Stender, Steen, Stewart, Alexandre F R, Szczeklik, Wojciech, Szpakowicz, Anna, Tardif, Jean-Claude, Ten Berg, Jurriën M, Tfelt-Hansen, Jacob, Thanassoulis, George, Thiery, Joachim, Torp-Pedersen, Christian, van der Graaf, Yolanda, Visseren, Frank L J, Waltenberger, Johannes, Weeke, Peter E, Van der Harst, Pim, Lang, Chim C, Sattar, Naveed, Cameron, Vicky A, Anderson, Jeffrey L, Brophy, James M, Paré, Guillaume, Horne, Benjamin D, März, Winfried, Wallentin, Lars, Samani, Nilesh J, Hingorani, Aroon D, and Asselbergs, Folkert W
Abstract: BACKGROUND: The "GENetIcs of sUbSequent Coronary Heart Disease" (GENIUS-CHD) consortium was established to facilitate discovery and validation of genetic variants and biomarkers for risk of subsequent CHD events, in individuals with established CHD.METHODS: The consortium currently includes 57 studies from 18 countries, recruiting 185,614 participants with either acute coronary syndrome, stable CHD or a mixture of both at baseline. All studies collected biological samples and followed-up study participants prospectively for subsequent events.RESULTS: Enrollment into the individual studies took place between 1985 to present day with duration of follow up ranging from 9 months to 15 years. Within each study, participants with CHD are predominantly of self-reported European descent (38%-100%), mostly male (44%-91%) with mean ages at recruitment ranging from 40 to 75 years. Initial feasibility analyses, using a federated analysis approach, yielded expected associations between age (HR 1.15 95% CI 1.14-1.16) per 5-year increase, male sex (HR 1.17, 95% CI 1.13-1.21) and smoking (HR 1.43, 95% CI 1.35-1.51) with risk of subsequent CHD death or myocardial infarction, and differing associations with other individual and composite cardiovascular endpoints.CONCLUSIONS: GENIUS-CHD is a global collaboration seeking to elucidate genetic and non-genetic determinants of subsequent event risk in individuals with established CHD, in order to improve residual risk prediction and identify novel drug targets for secondary prevention. Initial analyses demonstrate the feasibility and reliability of a federated analysis approach. The consortium now plans to initiate and test novel hypotheses as well as supporting replication and validation analyses for other investigators.
Published: 2019

45. Sex Differences in Clinical Characteristics, Psychosocial Factors, and Outcomes Among Patients With Stable Coronary Heart Disease : Insights from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial

Author: Guimaraes, Patricia Oliveira, Granger, Christopher B., Stebbins, Amanda, Chiswell, Karen, Held, Claes, Hochman, Judith S., Krug-Gourley, Susan, Lonn, Eva, Lopes, Renato D., Stewart, Ralph A. H., Vinereanu, Dragos, Wallentin, Lars, White, Harvey D., Hagström, Emil, Danchin, Nicolas, Guimaraes, Patricia Oliveira, Granger, Christopher B., Stebbins, Amanda, Chiswell, Karen, Held, Claes, Hochman, Judith S., Krug-Gourley, Susan, Lonn, Eva, Lopes, Renato D., Stewart, Ralph A. H., Vinereanu, Dragos, Wallentin, Lars, White, Harvey D., Hagström, Emil, and Danchin, Nicolas
Abstract: Background-Greater understanding of differences between men and women with coronary heart disease is needed. Methods and Results-In this post hoc analysis of the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) trial, we described psychosocial factors, treatments, and outcomes of men versus women with stable coronary heart disease and explored the association of sex with psychosocial characteristics and cardiovascular risk. Cox proportional hazards models were used to assess the relationship between sex and outcomes. Interactions among sex, psychosocial factors, and the composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke were tested. Of 15 828 patients, 2967 (19%) were women. Among women, 21.2% felt often or always stressed at home (versus 9.8% of men), and 19.2% felt often or always sad or depressed (versus 10.1% of men; all P<0.0001). The median duration of follow-up was 3.7 years (25th-75th percentiles: 3.5-3.8 years). Use of evidence-based medications for coronary heart disease at baseline and 24 months was similar between sexes, as were event rates for all outcomes analyzed. In the multivariable model including psychosocial measures, female sex was associated with lower cardiovascular risk. There was a statistically significant interaction (P=0.03) such that the lower risk in women varied by depressive symptom frequency, whereby women who were more depressed had a risk similar to men. Conclusions-Female sex was independently associated with better long-term clinical outcomes, although this was modified by frequency of depressive symptoms. This suggests that emotional state may be an important target for improving outcomes in patients with coronary heart disease, specifically in women.
Published: 2017
Full Text: View/download PDF

46. Sex Differences in Clinical Characteristics, Psychosocial Factors, and Outcomes Among Patients With Stable Coronary Heart Disease : Insights from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial

Author: Guimaraes, Patricia Oliveira, Granger, Christopher B., Stebbins, Amanda, Chiswell, Karen, Held, Claes, Hochman, Judith S., Krug-Gourley, Susan, Lonn, Eva, Lopes, Renato D., Stewart, Ralph A. H., Vinereanu, Dragos, Wallentin, Lars, White, Harvey D., Hagström, Emil, Danchin, Nicolas, Guimaraes, Patricia Oliveira, Granger, Christopher B., Stebbins, Amanda, Chiswell, Karen, Held, Claes, Hochman, Judith S., Krug-Gourley, Susan, Lonn, Eva, Lopes, Renato D., Stewart, Ralph A. H., Vinereanu, Dragos, Wallentin, Lars, White, Harvey D., Hagström, Emil, and Danchin, Nicolas
Abstract: Background-Greater understanding of differences between men and women with coronary heart disease is needed. Methods and Results-In this post hoc analysis of the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) trial, we described psychosocial factors, treatments, and outcomes of men versus women with stable coronary heart disease and explored the association of sex with psychosocial characteristics and cardiovascular risk. Cox proportional hazards models were used to assess the relationship between sex and outcomes. Interactions among sex, psychosocial factors, and the composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke were tested. Of 15 828 patients, 2967 (19%) were women. Among women, 21.2% felt often or always stressed at home (versus 9.8% of men), and 19.2% felt often or always sad or depressed (versus 10.1% of men; all P<0.0001). The median duration of follow-up was 3.7 years (25th-75th percentiles: 3.5-3.8 years). Use of evidence-based medications for coronary heart disease at baseline and 24 months was similar between sexes, as were event rates for all outcomes analyzed. In the multivariable model including psychosocial measures, female sex was associated with lower cardiovascular risk. There was a statistically significant interaction (P=0.03) such that the lower risk in women varied by depressive symptom frequency, whereby women who were more depressed had a risk similar to men. Conclusions-Female sex was independently associated with better long-term clinical outcomes, although this was modified by frequency of depressive symptoms. This suggests that emotional state may be an important target for improving outcomes in patients with coronary heart disease, specifically in women.
Published: 2017
Full Text: View/download PDF

47. Sex Differences in Clinical Characteristics, Psychosocial Factors, and Outcomes Among Patients With Stable Coronary Heart Disease : Insights from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial

Author: Guimaraes, Patricia Oliveira, Granger, Christopher B., Stebbins, Amanda, Chiswell, Karen, Held, Claes, Hochman, Judith S., Krug-Gourley, Susan, Lonn, Eva, Lopes, Renato D., Stewart, Ralph A. H., Vinereanu, Dragos, Wallentin, Lars, White, Harvey D., Hagström, Emil, Danchin, Nicolas, Guimaraes, Patricia Oliveira, Granger, Christopher B., Stebbins, Amanda, Chiswell, Karen, Held, Claes, Hochman, Judith S., Krug-Gourley, Susan, Lonn, Eva, Lopes, Renato D., Stewart, Ralph A. H., Vinereanu, Dragos, Wallentin, Lars, White, Harvey D., Hagström, Emil, and Danchin, Nicolas
Abstract: Background-Greater understanding of differences between men and women with coronary heart disease is needed. Methods and Results-In this post hoc analysis of the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) trial, we described psychosocial factors, treatments, and outcomes of men versus women with stable coronary heart disease and explored the association of sex with psychosocial characteristics and cardiovascular risk. Cox proportional hazards models were used to assess the relationship between sex and outcomes. Interactions among sex, psychosocial factors, and the composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke were tested. Of 15 828 patients, 2967 (19%) were women. Among women, 21.2% felt often or always stressed at home (versus 9.8% of men), and 19.2% felt often or always sad or depressed (versus 10.1% of men; all P<0.0001). The median duration of follow-up was 3.7 years (25th-75th percentiles: 3.5-3.8 years). Use of evidence-based medications for coronary heart disease at baseline and 24 months was similar between sexes, as were event rates for all outcomes analyzed. In the multivariable model including psychosocial measures, female sex was associated with lower cardiovascular risk. There was a statistically significant interaction (P=0.03) such that the lower risk in women varied by depressive symptom frequency, whereby women who were more depressed had a risk similar to men. Conclusions-Female sex was independently associated with better long-term clinical outcomes, although this was modified by frequency of depressive symptoms. This suggests that emotional state may be an important target for improving outcomes in patients with coronary heart disease, specifically in women.
Published: 2017
Full Text: View/download PDF

48. beta-Blockers and Mortality After Acute Myocardial Infarction in Patients Without Heart Failure or Ventricular Dysfunction

Author: Dondo, Tatendashe B., Hall, Marlous, West, Robert M., Jernberg, Tomas, Lindahl, Bertil, Bueno, Hector, Danchin, Nicolas, Deanfield, John E., Hemingway, Harry, Fox, Keith A. A., Timmis, Adam D., Gale, Chris P., Dondo, Tatendashe B., Hall, Marlous, West, Robert M., Jernberg, Tomas, Lindahl, Bertil, Bueno, Hector, Danchin, Nicolas, Deanfield, John E., Hemingway, Harry, Fox, Keith A. A., Timmis, Adam D., and Gale, Chris P.
Abstract: BACKGROUND: For acute myocardial infarction (AMI) without heart failure (HF), it is unclear if beta-blockers are associated with reduced mortality. OBJECTIVES: The goal of this study was to determine the association between beta-blocker use and mortality in patients with AMI without HF or left ventricular systolic dysfunction (LVSD). METHODS: This cohort study used national English and Welsh registry data from the Myocardial Ischaemia National Audit Project. A total of 179,810 survivors of hospitalization with AMI without HF or LVSD, between January 1, 2007, and June 30, 2013 (final follow-up: December 31, 2013), were assessed. Survival-time inverse probability weighting propensity scores and instrumental variable analyses were used to investigate the association between the use of beta-blockers and 1-year mortality. RESULTS: Of 91,895 patients with ST-segment elevation myocardial infarction and 87,915 patients with non-ST-segment elevation myocardial infarction, 88,542 (96.4%) and 81,933 (93.2%) received beta-blockers, respectively. For the entire cohort, with> 163,772 person-years of observation, there were 9,373 deaths (5.2%). Unadjusted 1-year mortality was lower for patients who received beta-blockers compared with those who did not (4.9% vs. 11.2%; p < 0.001). However, after weighting and adjustment, there was no significant difference in mortality between those with and without beta-blocker use (average treatment effect [ATE] coefficient: 0.07; 95% confidence interval [CI]: -0.60 to 0.75; p = 0.827). Findings were similar for ST-segment elevation myocardial infarction (ATE coefficient: 0.30; 95% CI: -0.98 to 1.58; p = 0.637) and non-ST-segment elevation myocardial infarction (ATE coefficient: -0.07; 95% CI: -0.68 to 0.54; p = 0.819). CONCLUSIONS: Among survivors of hospitalization with AMI who did not have HF or LVSD as recorded in the hospital, the use of beta-blockers was not associated with a lower risk of death at any time point up to 1 year.
Published: 2017
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49. beta-Blockers and Mortality After Acute Myocardial Infarction in Patients Without Heart Failure or Ventricular Dysfunction

Author: Dondo, Tatendashe B., Hall, Marlous, West, Robert M., Jernberg, Tomas, Lindahl, Bertil, Bueno, Hector, Danchin, Nicolas, Deanfield, John E., Hemingway, Harry, Fox, Keith A. A., Timmis, Adam D., Gale, Chris P., Dondo, Tatendashe B., Hall, Marlous, West, Robert M., Jernberg, Tomas, Lindahl, Bertil, Bueno, Hector, Danchin, Nicolas, Deanfield, John E., Hemingway, Harry, Fox, Keith A. A., Timmis, Adam D., and Gale, Chris P.
Abstract: BACKGROUND: For acute myocardial infarction (AMI) without heart failure (HF), it is unclear if beta-blockers are associated with reduced mortality. OBJECTIVES: The goal of this study was to determine the association between beta-blocker use and mortality in patients with AMI without HF or left ventricular systolic dysfunction (LVSD). METHODS: This cohort study used national English and Welsh registry data from the Myocardial Ischaemia National Audit Project. A total of 179,810 survivors of hospitalization with AMI without HF or LVSD, between January 1, 2007, and June 30, 2013 (final follow-up: December 31, 2013), were assessed. Survival-time inverse probability weighting propensity scores and instrumental variable analyses were used to investigate the association between the use of beta-blockers and 1-year mortality. RESULTS: Of 91,895 patients with ST-segment elevation myocardial infarction and 87,915 patients with non-ST-segment elevation myocardial infarction, 88,542 (96.4%) and 81,933 (93.2%) received beta-blockers, respectively. For the entire cohort, with> 163,772 person-years of observation, there were 9,373 deaths (5.2%). Unadjusted 1-year mortality was lower for patients who received beta-blockers compared with those who did not (4.9% vs. 11.2%; p < 0.001). However, after weighting and adjustment, there was no significant difference in mortality between those with and without beta-blocker use (average treatment effect [ATE] coefficient: 0.07; 95% confidence interval [CI]: -0.60 to 0.75; p = 0.827). Findings were similar for ST-segment elevation myocardial infarction (ATE coefficient: 0.30; 95% CI: -0.98 to 1.58; p = 0.637) and non-ST-segment elevation myocardial infarction (ATE coefficient: -0.07; 95% CI: -0.68 to 0.54; p = 0.819). CONCLUSIONS: Among survivors of hospitalization with AMI who did not have HF or LVSD as recorded in the hospital, the use of beta-blockers was not associated with a lower risk of death at any time point up to 1 year.
Published: 2017
Full Text: View/download PDF

50. beta-Blockers and Mortality After Acute Myocardial Infarction in Patients Without Heart Failure or Ventricular Dysfunction

Author: Dondo, Tatendashe B., Hall, Marlous, West, Robert M., Jernberg, Tomas, Lindahl, Bertil, Bueno, Hector, Danchin, Nicolas, Deanfield, John E., Hemingway, Harry, Fox, Keith A. A., Timmis, Adam D., Gale, Chris P., Dondo, Tatendashe B., Hall, Marlous, West, Robert M., Jernberg, Tomas, Lindahl, Bertil, Bueno, Hector, Danchin, Nicolas, Deanfield, John E., Hemingway, Harry, Fox, Keith A. A., Timmis, Adam D., and Gale, Chris P.
Abstract: BACKGROUND: For acute myocardial infarction (AMI) without heart failure (HF), it is unclear if beta-blockers are associated with reduced mortality. OBJECTIVES: The goal of this study was to determine the association between beta-blocker use and mortality in patients with AMI without HF or left ventricular systolic dysfunction (LVSD). METHODS: This cohort study used national English and Welsh registry data from the Myocardial Ischaemia National Audit Project. A total of 179,810 survivors of hospitalization with AMI without HF or LVSD, between January 1, 2007, and June 30, 2013 (final follow-up: December 31, 2013), were assessed. Survival-time inverse probability weighting propensity scores and instrumental variable analyses were used to investigate the association between the use of beta-blockers and 1-year mortality. RESULTS: Of 91,895 patients with ST-segment elevation myocardial infarction and 87,915 patients with non-ST-segment elevation myocardial infarction, 88,542 (96.4%) and 81,933 (93.2%) received beta-blockers, respectively. For the entire cohort, with> 163,772 person-years of observation, there were 9,373 deaths (5.2%). Unadjusted 1-year mortality was lower for patients who received beta-blockers compared with those who did not (4.9% vs. 11.2%; p < 0.001). However, after weighting and adjustment, there was no significant difference in mortality between those with and without beta-blocker use (average treatment effect [ATE] coefficient: 0.07; 95% confidence interval [CI]: -0.60 to 0.75; p = 0.827). Findings were similar for ST-segment elevation myocardial infarction (ATE coefficient: 0.30; 95% CI: -0.98 to 1.58; p = 0.637) and non-ST-segment elevation myocardial infarction (ATE coefficient: -0.07; 95% CI: -0.68 to 0.54; p = 0.819). CONCLUSIONS: Among survivors of hospitalization with AMI who did not have HF or LVSD as recorded in the hospital, the use of beta-blockers was not associated with a lower risk of death at any time point up to 1 year.
Published: 2017
Full Text: View/download PDF

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