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

Author: 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
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Patient Safety, Clinical Research, 6.1 Pharmaceuticals, Good Health and Well Being, Humans, Antibodies, Monoclonal, Humanized, Anticholesteremic Agents, Biomarkers, Cardiovascular Diseases, Cholesterol, LDL, Dyslipidemias, PCSK9 Inhibitors, Proprotein Convertase 9, Randomized Controlled Trials as Topic, Serine Proteinase Inhibitors, Time Factors, Treatment Outcome, ODYSSEY OUTCOMES Investigators, Alirocumab, Cholesterol, PCSK9, Safety, Cardiorespiratory Medicine and Haematology, Pharmacology and Pharmaceutical Sciences, Cardiovascular medicine and haematology, Pharmacology and pharmaceutical sciences
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. Measuring Ambulatory Racial and Ethnic Neurologic Disparities With the Axon Registry.

Author: Marulanda-Londono, Erika, Hope, Omotola, Pham, Tammy, Roe, Matthew, Torres, Aracelis, Lien, Amanda, Kauwe, Steven, Lundgren, Karen, Mante, Aristotle, Schierman, Becky, Jones, Lyell, Benson, Richard, Benish, Sarah, Esper, Gregory, Kissela, Brett, and Rosendale, Nicole
Abstract: BACKGROUND AND OBJECTIVES: The primary objective is to examine potential racial and ethnic (R/E) disparities in ambulatory neurology quality measures within the American Academy of Neurology Axon Registry. R/E disparities in neurologic US morbidity and mortality have been clearly documented. Despite these findings, there have been no nationwide examinations of how ambulatory neurologic care affects these negative health outcomes. METHODS: This was a retrospective nonrandomized cohort study of patients in the AAN Axon Registry. The Axon Registry is a neurology-specific outpatient quality registry that collects, reports, and analyzes real-world deidentified electronic health record (EHR) data. Patients were included in the study if they contributed toward one of the selected quality measures for multiple sclerosis, epilepsy, Parkinson disease, or headache during the study period of January 1, 2019-December 31, 2019. Descriptive analyses of patient demographics were performed and then stratified by race and ethnicity. RESULTS: There were a total of 633,672 patients included in these analyses. Separate analyses were performed for race (64% White, 8% Black, 1% Asian, and 27% unknown) and ethnicity (52% not Hispanic, 5% Hispanic, and 43% unknown). The mean age ranged from 18 to 55 years, with 61% female and 39% male. Quality measures were chosen based on completeness of R/E data and were either process or outcomes focused. Statistically significant differences were noted after controlling for multiple comparisons. DISCUSSION: The large proportion of missing or unknown R/E data and low overall rate of performance on these quality measures made the relevance of small differences difficult to determine. This analysis demonstrates the feasibility of using the Axon Registry to assess neurologic disparities in outpatient care. More education and training are required on the accurate capture of R/E data in the EHR.
Published: 2023

3. Impact of the COVID-19 Pandemic on Urological Care Delivery in the United States

Author: Lee, Daniel J, Shelton, Jeremy B, Brendel, Paul, Doraiswami, Rahul, Makarov, Danil, Meeks, William, Fang, Raymond, Roe, Matthew T, and Cooperberg, Matthew R
Subjects: Health Services, Clinical Research, Good Health and Well Being, Adolescent, Adult, Aged, Ambulatory Care, COVID-19, Communicable Disease Control, Female, Humans, Male, Middle Aged, Pandemics, Patient Acceptance of Health Care, Practice Patterns, Physicians', Telemedicine, United States, Urologic Diseases, Urologic Surgical Procedures, Urology, Young Adult, health services research, socioeconomic factors, healthcare disparities, urology
Abstract: PurposeWe examined changes in urological care delivery due to COVID-19 in the U.S. based on patient, practice, and local/regional demographic and pandemic response features.Materials and methodsWe analyzed real-world data from the American Urological Association Quality (AQUA) Registry collected from electronic health record systems. Data represented 157 outpatient urological practices and 3,165 providers across 48 U.S. states and territories, including 3,297,721 unique patients, 12,488,831 total outpatient visits and 2,194,456 procedures. The primary outcome measure was the number of outpatient visits and procedures performed (inpatient or outpatient) per practice per week, measured from January 2019 to February 2021.ResultsWe found large (>50%) declines in outpatient visits from March 2020 to April 2020 across patient demographic groups and states, regardless of timing of state stay-at-home orders. Nonurgent outpatient visits decreased more across various nonurgent procedures (49%-59%) than for procedures performed for potentially urgent diagnoses (38%-52%); surgical procedures for nonurgent conditions also decreased more (43%-79%) than those for potentially urgent conditions (43%-53%). African American patients had similar decreases in outpatient visits compared with Asians and Caucasians, but also slower recoveries back to baseline. Medicare-insured patients had the steepest declines (55%), while those on Medicaid and government insurance had the lowest percentage of recovery to baseline (73% and 69%, respectively).ConclusionsThis study provides real-world evidence on the decline in urological care across demographic groups and practice settings, and demonstrates a differential impact on the utilization of urological health services by demographics and procedure type.
Published: 2021

4. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial

Author: Lopes, Renato D, Higano, Celestia S, Slovin, Susan F, Nelson, Adam J, Bigelow, Robert, Sørensen, Per S, Melloni, Chiara, Goodman, Shaun G, Evans, Christopher P, Nilsson, Jan, Bhatt, Deepak L, Clarke, Noel W, Olesen, Tine K, Doyle-Olsen, Belinda T, Kristensen, Henriette, Arney, Lauren, Roe, Matthew T, Alexander, John H, Mol-Arts, Mirjam, Mansor-Lefebvre, Samreen, Zubovskiy, Konstantin, Blemings, Allan, Dugi, Klaus, Bloomfield, Gerald, Kontos, Chris, DeVore, Adam, Jordan, Dedrick, Kolls, Bradley, Matthews, Robin, Mehta, Rajendra, Povsic, Thomas J, Morse, Michael, Mahaffey, Kenneth W, Halabi, Susan, Leong, Darryl, Klotz, Laurence, Fleshner, Neil, Jansz, Godfrey, Giddens, Jonathan, Egerdie, Russell, Chin, Joseph, Zadra, Joseph, Casey, Richard, Simard, Jean, Niazi, Tamim, Martin, André-Guy, Babjuk, Marek, Hajek, Jaroslav, Klecka, Jiri, Kubes, Jiri, Schraml, Jan, Jakesova, Jitka, Vanasek, Jaroslav, Melichar, Bohuslav, Seikkula, Heikki, Abdiche, Manouar Samir, Colombel, Marc, Debourdeau, Philippe, Robert, Gregoire, Villers, Arnauld, Ploussard, Guillaume, Pradere, Benjamin, Bruyere, Franck, Descotes, Jean-Luc, Ouzaid, Idir, Winter, Alexander, Hanitzsch, Herbert, Sperling, Herbert, Eckert, Ralf, Hammerer, Peter, Stagge, Elke, Seseke, Florian, Szymula, Silvio, Bamias, Aristotelis, Thanos, Anastasios, Hatzimouratidis, Konstantinos, Mamoulakis, Charalambos, Kalofonos, Haralabos, Oszukowska, Elzbieta, Madziarska, Katarzyna, Fijuth, Jacek, Obarzanowski, Mateusz, Alekseev, Boris, Atduev, Vagif, Pushkar, Dmitri, Veliev, Evgeniy, Zyryanov, Alexander, Petrov, Sergey, Kopyltsov, Evgeny, Kozlov, Vadim, Macko, Ladislav, Dubravicky, Jozef, Polak, Richard, Mir, Obaidullah, Vargovcak, Marek, Mincik, Ivan, Kliment, Jan, Goncalves, Frederico, Mikulas, Juraj, and Sokol, Roman
Subjects: Cancer, Clinical Trials and Supportive Activities, Patient Safety, Aging, Prostate Cancer, Urologic Diseases, Cardiovascular, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Aged, Humans, Leuprolide, Male, Oligopeptides, Prospective Studies, Prostatic Neoplasms, agonists, atherosclerosis, cardiotoxicity, drug therapy, gonadotropin-releasing hormone, prostatic neoplasms, PRONOUNCE Study Investigators, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract: BackgroundThe relative cardiovascular safety of gonadotropin-releasing hormone (GnRH) antagonists compared with GnRH agonists in men with prostate cancer and known atherosclerotic cardiovascular disease remains controversial.MethodsIn this international, multicenter, prospective, randomized, open-label trial, men with prostate cancer and concomitant atherosclerotic cardiovascular disease were randomly assigned 1:1 to receive the GnRH antagonist degarelix or the GnRH agonist leuprolide for 12 months. The primary outcome was the time to first adjudicated major adverse cardiovascular event (composite of death, myocardial infarction, or stroke) through 12 months.ResultsBecause of slower-than-projected enrollment and fewer-than-projected primary outcome events, enrollment was stopped before the 900 planned participants were accrued. From May 3, 2016, to April 16, 2020, a total of 545 patients from 113 sites across 12 countries were randomly selected. Baseline characteristics were balanced between study groups. The median age was 73 years, 49.8% had localized prostate cancer; 26.3% had locally advanced disease, and 20.4% had metastatic disease. A major adverse cardiovascular event occurred in 15 (5.5%) patients assigned to degarelix and 11 (4.1%) patients assigned to leuprolide (hazard ratio, 1.28 [95% CI, 0.59-2.79]; P=0.53).ConclusionsPRONOUNCE (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease) is the first, international, randomized clinical trial to prospectively compare the cardiovascular safety of a GnRH antagonist and a GnRH agonist in patients with prostate cancer. The study was terminated prematurely because of the smaller than planned number of participants and events, and no difference in major adverse cardiovascular events at 1 year between patients assigned to degarelix or leuprolide was observed. The relative cardiovascular safety of GnRH antagonists and agonists remains unresolved. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02663908.
Published: 2021

5. Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease

Author: Jones, W Schuyler, Mulder, Hillary, Wruck, Lisa M, Pencina, Michael J, Kripalani, Sunil, Muñoz, Daniel, Crenshaw, David L, Effron, Mark B, Re, Richard N, Gupta, Kamal, Anderson, R David, Pepine, Carl J, Handberg, Eileen M, Manning, Brittney R, Jain, Sandeep K, Girotra, Saket, Riley, Danielle, DeWalt, Darren A, Whittle, Jeff, Goldberg, Ythan H, Roger, Veronique L, Hess, Rachel, Benziger, Catherine P, Farrehi, Peter, Zhou, Li, Ford, Daniel E, Haynes, Kevin, VanWormer, Jeffrey J, Knowlton, Kirk U, Kraschnewski, Jennifer L, Polonsky, Tamar S, Fintel, Dan J, Ahmad, Faraz S, McClay, James C, Campbell, James R, Bell, Douglas S, Fonarow, Gregg C, Bradley, Steven M, Paranjape, Anuradha, Roe, Matthew T, Robertson, Holly R, Curtis, Lesley H, Sharlow, Amber G, Berdan, Lisa G, Hammill, Bradley G, Harris, Debra F, Qualls, Laura G, Marquis-Gravel, Guillaume, Modrow, Madelaine F, Marcus, Gregory M, Carton, Thomas W, Nauman, Elizabeth, Waitman, Lemuel R, Kho, Abel N, Shenkman, Elizabeth A, McTigue, Kathleen M, Kaushal, Rainu, Masoudi, Frederick A, Antman, Elliott M, Davidson, Desiree R, Edgley, Kevin, Merritt, James G, Brown, Linda S, Zemon, Doris N, McCormick, Thomas E, Alikhaani, Jacqueline D, Gregoire, Kenneth C, Rothman, Russell L, Harrington, Robert A, and Hernandez, Adrian F
Subjects: Clinical Trials and Supportive Activities, Heart Disease - Coronary Heart Disease, Cardiovascular, Patient Safety, Comparative Effectiveness Research, Clinical Research, Heart Disease, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Aged, Aspirin, Atherosclerosis, Cardiovascular Diseases, Female, Hemorrhage, Hospitalization, Humans, Male, Medication Adherence, Middle Aged, Myocardial Infarction, Platelet Aggregation Inhibitors, Secondary Prevention, Stroke, ADAPTABLE Team, Medical and Health Sciences, General & Internal Medicine
Abstract: BackgroundThe appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.MethodsUsing an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis.ResultsA total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]).ConclusionsIn this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).
Published: 2021

6. Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer: The PRONOUNCE Trial Study Design.

Author: Melloni, Chiara, Slovin, Susan, Blemings, Allan, Goodman, Shaun, Evans, Christopher, Nilsson, Jan, Bhatt, Deepak, Zubovskiy, Konstantin, Olesen, Tine, Dugi, Klaus, Clarke, Noel, Higano, Celestia, and Roe, Matthew
Subjects: ADT, androgen deprivation therapy, ASCVD, atherosclerotic cardiovascular disease, CI, confidence interval, DSMB, Data Safety Monitoring Board, GnRH, gonadotropin-releasing hormone, MACE, major adverse cardiovascular event, cardiovascular safety, outcomes, prostate cancer
Abstract: OBJECTIVES: This study will compare the incidence of major adverse cardiovascular events (MACEs) with androgen deprivation therapy (ADT) among men with advanced prostate cancer who are being treated with a gonadotropin-releasing hormone (GnRH) antagonist versus a GnRH agonist. BACKGROUND: Treatment of advanced prostate cancer with ADT might increase the risk of subsequent cardiovascular events among men with known atherosclerotic cardiovascular disease (ASCVD), but a recent meta-analysis suggested that this risk might be lower with ADT using a GnRH antagonist versus a GnRH agonist. METHODS: PRONOUNCE is a multicenter, prospective, randomized, open, blinded endpoint trial that will enroll approximately 900 patients with advanced prostate cancer and pre-existing ASCVD who will be treated with ADT. Participants will be randomized to receive the GnRH antagonist degarelix or the GnRH agonist leuprolide as ADT for 12 months. The primary endpoint is time from randomization to first confirmed, adjudicated occurrence of a MACE, which is defined as a composite of all-cause death, nonfatal myocardial infarction, or nonfatal stroke through 12 months of ADT treatment. Baseline cardiovascular biomarkers (high-sensitivity C-reactive protein, high-sensitivity troponin T, and N-terminal pro-brain natriuretic peptide), as well as serial inflammatory and immune biomarkers, will be evaluated in exploratory analyses. RESULTS: As of October 1, 2019, a total of 364 patients have been enrolled. The mean age is 74 years, 90% are white, 80% have hypertension or dyslipidemia, 30% diabetes mellitus, 40% have had a previous myocardial infarction, and 65% have had previous revascularization. Regarding prostate cancer features at randomization, 48% of the patients had localized disease, 23% had locally advanced disease, and 18% had metastatic disease. CONCLUSIONS: PRONOUNCE is the first prospective cardiovascular outcomes trial in advanced prostate cancer that will delineate whether the risk of subsequent cardiovascular events associated with ADT is lower with a GnRH antagonist versus a GnRH agonist for men with pre-existing ASCVD. (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease [PRONOUNCE]; NCT02663908).
Published: 2020

7. Effect of Alirocumab on Lipoprotein(a) and Cardiovascular Risk After Acute Coronary Syndrome

Author: Bittner, Vera A, Szarek, Michael, Aylward, Philip E, Bhatt, Deepak L, Diaz, Rafael, Edelberg, Jay M, Fras, Zlatko, Goodman, Shaun G, Halvorsen, Sigrun, Hanotin, Corinne, Harrington, Robert A, Jukema, J Wouter, Loizeau, Virginie, Moriarty, Patrick M, Moryusef, Angèle, Pordy, Robert, Roe, Matthew T, Sinnaeve, Peter, Tsimikas, Sotirios, Vogel, Robert, White, Harvey D, Zahger, Doron, Zeiher, Andreas M, Steg, Ph Gabriel, Schwartz, Gregory G, and Committees and Investigators, ODYSSEY OUTCOMES
Subjects: Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Heart Disease, Atherosclerosis, Clinical Trials and Supportive Activities, Cardiovascular, Heart Disease - Coronary Heart Disease, Clinical Research, 6.1 Pharmaceuticals, Good Health and Well Being, Acute Coronary Syndrome, Adult, Aged, Antibodies, Monoclonal, Humanized, Cardiovascular Diseases, Cholesterol, LDL, Female, Humans, Lipoprotein(a), Male, Middle Aged, Risk Factors, Treatment Outcome, acute coronary syndromes, alirocumab, low-density lipoprotein cholesterol, major adverse cardiovascular events, proprotein convertase subtilisin/kexin type 9 inhibition, ODYSSEY OUTCOMES Committees and Investigators, major adverse cardiovascular events, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract: BackgroundLipoprotein(a) concentration is associated with cardiovascular events. Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, lowers lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C).ObjectivesA pre-specified analysis of the placebo-controlled ODYSSEY Outcomes trial in patients with recent acute coronary syndrome (ACS) determined whether alirocumab-induced changes in lipoprotein(a) and LDL-C independently predicted major adverse cardiovascular events (MACE).MethodsOne to 12 months after ACS, 18,924 patients on high-intensity statin therapy were randomized to alirocumab or placebo and followed for 2.8 years (median). Lipoprotein(a) was measured at randomization and 4 and 12 months thereafter. The primary MACE outcome was coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina.ResultsBaseline lipoprotein(a) levels (median: 21.2 mg/dl; interquartile range [IQR]: 6.7 to 59.6 mg/dl) and LDL-C [corrected for cholesterol content in lipoprotein(a)] predicted MACE. Alirocumab reduced lipoprotein(a) by 5.0 mg/dl (IQR: 0 to 13.5 mg/dl), corrected LDL-C by 51.1 mg/dl (IQR: 33.7 to 67.2 mg/dl), and reduced the risk of MACE (hazard ratio [HR]: 0.85; 95% confidence interval [CI]: 0.78 to 0.93). Alirocumab-induced reductions of lipoprotein(a) and corrected LDL-C independently predicted lower risk of MACE, after adjustment for baseline concentrations of both lipoproteins and demographic and clinical characteristics. A 1-mg/dl reduction in lipoprotein(a) with alirocumab was associated with a HR of 0.994 (95% CI: 0.990 to 0.999; p = 0.0081).ConclusionsBaseline lipoprotein(a) and corrected LDL-C levels and their reductions by alirocumab predicted the risk of MACE after recent ACS. Lipoprotein(a) lowering by alirocumab is an independent contributor to MACE reduction, which suggests that lipoprotein(a) should be an independent treatment target after ACS. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402).
Published: 2020

8. Miguel Coyula Aquino : REVOLUTIONARY WITNESS

Author: Roe, Matthew David
Published: 2021

9. Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial.

Author: Ray, Kausik K, Colhoun, Helen M, Szarek, Michael, Baccara-Dinet, Marie, Bhatt, Deepak L, Bittner, Vera A, Budaj, Andrzej J, Diaz, Rafael, Goodman, Shaun G, Hanotin, Corinne, Harrington, Robert A, Jukema, J Wouter, Loizeau, Virginie, Lopes, Renato D, Moryusef, Angèle, Murin, Jan, Pordy, Robert, Ristic, Arsen D, Roe, Matthew T, Tuñón, José, White, Harvey D, Zeiher, Andreas M, Schwartz, Gregory G, and Steg, Philippe Gabriel
Abstract: After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events. A reduction in mean LDL cholesterol to 1·4-1·8 mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. However, the efficacy and safety of further reduction in LDL cholesterol with an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) after acute coronary syndrome is unknown. We aimed to explore this issue in a prespecified analysis of the ODYSSEY OUTCOMES trial of the PCSK9 inhibitor alirocumab, assessing its effects on cardiovascular outcomes by baseline glycaemic status, while also assessing its effects on glycaemic measures including risk of new-onset diabetes.ODYSSEY OUTCOMES was a randomised, double-blind, placebo-controlled trial, done at 1315 sites in 57 countries, that compared alirocumab with placebo in patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1-12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins. Patients were randomly assigned (1:1) to receive alirocumab or placebo every 2 weeks; randomisation was stratified by country and was done centrally with an interactive voice-response or web-response system. Alirocumab was titrated to target LDL cholesterol concentrations of 0·65-1·30 mmol/L. In this prespecified analysis, we investigated the effect of alirocumab on cardiovascular events by glycaemic status at baseline (diabetes, prediabetes, or normoglycaemia)-defined on the basis of patient history, review of medical records, or baseline HbA1c or fasting serum glucose-and risk of new-onset diabetes among those without diabetes at baseline. The primary endpoint was a composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospital admission. ODYSSEY OUTCOMES is registered with ClinicalTrials.gov, number NCT01663402.At study baseline, 5444 patients (28·8%) had diabetes, 8246 (43·6%) had prediabetes, and 5234 (27·7%) had normoglycaemia. There were no significant differences across glycaemic categories in median LDL cholesterol at baseline (2·20-2·28 mmol/L), after 4 months' treatment with alirocumab (0·80 mmol/L), or after 4 months' treatment with placebo (2·25-2·28 mmol/L). In the placebo group, the incidence of the primary endpoint over a median of 2·8 years was greater in patients with diabetes (16·4%) than in those with prediabetes (9·2%) or normoglycaemia (8·5%); hazard ratio (HR) for diabetes versus normoglycaemia 2·09 (95% CI 1·78-2·46, p
Published: 2019

10. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome

Author: Schwartz, Gregory G, Steg, P. Gabriel, Szarek, Michael, Bhatt, Deepak L, Bittner, Vera A, Diaz, Rafael, Edelberg, Jay M, Goodman, Shaun G, Hanotin, Corinne, Harrington, Robert A, Jukema, J. Wouter, Lecorps, Guillaume, Mahaffey, Kenneth W, Moryusef, AngÃ¨le, Pordy, Robert, Quintero, Kirby, Roe, Matthew T, Sasiela, William J, Tamby, Jean-FranÃ§ois, Tricoci, Pierluigi, White, Harvey D, and Zeiher, Andreas M
Published: 2018

11. The Association of Frailty With In-Hospital Bleeding Among Older Adults With Acute Myocardial Infarction Insights From the ACTION Registry

Author: Dodson, John A, Hochman, Judith S, Roe, Matthew T, Chen, Anita Y, Chaudhry, Sarwat I, Katz, Stuart, Zhong, Hua, Radford, Martha J, Udell, Jacob, Bagai, Akshay, Fonarow, Gregg C, Gulati, Martha, Enriquez, Jonathan R, Garratt, Kirk N, and Alexander, Karen P
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Heart Disease, Patient Safety, Prevention, Heart Disease - Coronary Heart Disease, Cardiovascular, Clinical Research, Aging, Activities of Daily Living, Aged, Aged, 80 and over, Cardiac Catheterization, Cognition, Female, Frail Elderly, Frailty, Geriatric Assessment, Hemorrhage, Humans, Inpatients, Male, Mobility Limitation, Myocardial Infarction, Patient Admission, Percutaneous Coronary Intervention, Registries, Risk Assessment, Risk Factors, Treatment Outcome, United States, Walking, bleeding, geriatric, myocardial infarction, older adults, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract: ObjectivesThe aim of this study was to determine whether frailty is associated with increased bleeding risk in the setting of acute myocardial infarction (AMI).BackgroundFrailty is a common syndrome in older adults.MethodsFrailty was examined among AMI patients ≥65 years of age treated at 775 U.S. hospitals participating in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry from January 2015 to December 2016. Frailty was classified on the basis of impairments in 3 domains: walking (unassisted, assisted, wheelchair/nonambulatory), cognition (normal, mildly impaired, moderately/severely impaired), and activities of daily living. Impairment in each domain was scored as 0, 1, or 2, and a summary variable consisting of 3 categories was then created: 0 (fit/well), 1 to 2 (vulnerable/mild frailty), and 3 to 6 (moderate-to-severe frailty). Multivariable logistic regression was used to examine the independent association between frailty and bleeding.ResultsAmong 129,330 AMI patients, 16.4% had any frailty. Frail patients were older, more often female, and were less likely to undergo cardiac catheterization. Major bleeding increased across categories of frailty (fit/well 6.5%; vulnerable/mild frailty 9.4%; moderate-to-severe frailty 9.9%; p < 0.001). Among patients who underwent catheterization, both frailty categories were independently associated with bleeding risk compared with the non-frail group (vulnerable/mild frailty adjusted odds ratio [OR]: 1.33, 95% confidence interval [CI]: 1.23 to 1.44; moderate-to-severe frailty adjusted OR: 1.40, 95% CI: 1.24 to 1.58). Among patients managed conservatively, there was no association of frailty with bleeding (vulnerable/mild frailty adjusted OR: 1.01, 95% CI: 0.86 to 1.19; moderate-to-severe frailty adjusted OR: 0.96, 95% CI: 0.81 to 1.14).ConclusionsFrail patients had lower use of cardiac catheterization and higher risk of major bleeding (when catheterization was performed) than nonfrail patients, making attention to clinical strategies to avoid bleeding imperative in this population.
Published: 2018

12. Preexisting frailty and outcomes in older patients with acute myocardial infarction

Author: Udell, Jacob A., Lu, Di, Bagai, Akshay, Dodson, John A., Desai, Nihar R., Fonarow, Gregg C., Goyal, Abhinav, Garratt, Kirk N., Lucas, Joseph, Weintraub, William S., Forman, Daniel E., Roe, Matthew T., and Alexander, Karen P.
Published: 2022
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13. The National Cardiovascular Data Registry Data Quality Program 2020: JACC State-of-the-Art Review

Author: Malenka, David J., Bhatt, Deepak L., Bradley, Steven M., Shahian, David M., Draoui, Jasmine, Segawa, Claire A., Koutras, Christina, Abbott, Jinnette D., Blankenship, James C., Vincent, Robert, Windle, John, Tsai, Thomas T., Curtis, Jeptha, Roe, Matthew, and Masoudi, Frederick A.
Published: 2022
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14. Effects of repeated treatment with the 5-HT1A and 5-HT1B agonists (R)-( +)-8-hydroxy-DPAT and CP-94253 on the locomotor activity and axillary temperatures of preweanling rats: evidence of tolerance and behavioral sensitization

Author: McDougall, Sanders A., Taylor, Jordan A., Roe, Matthew J., and Greenwood, Constance J.
Published: 2022
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15. 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., Schwartz, Gregory G., Bhatt, Deepak L., Bittner, Vera A., Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Szarek, Michael, White, Harvey D., Zeiher, Andreas M., Tricoci, Pierluigi, Roe, Matthew T., Mahaffey, Kenneth W., Edelberg, Jay M., Hanotin, Corinne, Lecorps, Guillaume, Moryusef, Angèle, Pordy, Robert, Sasiela, William J., Tamby, Jean-François, Diaz, Rafael, Aylward, Philip E, Drexel, Heinz, Sinnaeve, Peter, Dilic, Mirza, Lopes, Renato D., Gotcheva, Nina N, Goodman, Shaun G., 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, Carlos, Pablo, Valdovinos, 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, Ramos López, Gabriel Arturo, Alings, Marco, White, Harvey D., Halvorsen, Sigrun, Correa Flores, Roger M, 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. 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Nimali, Fernando, Kaputella, Jayawardena, Jayanthimala, Wijeyasingam, Santharaj, Ranasinghe, Gotabhaya, Ekanayaka, Ruvan, Mendis, Sepalika, Senaratne, Vajira, Mayurathan, Gnanamoorthy, Rajapaksha, Ajantha, Sirisena, Thilak, Herath, Jagath I, Amarasena, Naomali, Berglund, Stefan, Rasmanis, Gundars, Hagström, Emil, Vedin, Ola, Witt, Nils, Mourtzinis, Georgios, Nicol, Peter, Hansen, Ole, Romeo, Stefano, Jensen, Steen Agergaard, Torstensson, Ingemar, Ahremark, Ulf, Sundelin, Torbjörn, Moccetti, Tiziano, Müller, Christian, Mach, Francois, Binde, Ronald, Landmesser, Ulf, Gämperli, Oliver, Chiang, Chern-En, Tsai, Wei- Chuan, Ueng, Kwo-Chang, Lai, Wen-Ter, Liu, Ming-En, Hwang, Juey- Jen, Yin, Wei-Hsian, Hsieh, I-Chang, Hsieh, Ming-Jer, Hsiang Lin, Wei, Kuo, Jen-Yuan, Huang, Tsuei-Yuan, Fang, Chih-Yuan, Kaewsuwanna, Pinij, Soonfuang, Wasant, Jintapakorn, Woravut, Sukonthasarn, Apichard, Sritara, Piyamitr, Wongpraparut, Nattawut, Sastravaha, Krisada, Sansanayudh, Nakarin, Kehasukcharoen, Wirash, Piyayotai, Dilok, Chotnoparatpat, Paiboon, Camsari, Ahmet, Kultursay, Hakan, Guneri, Sema, Mutlu, Bulent, Ersanli, Murat, Demirtas, Mustafa, Kirma, Cevat, Ural, Ertan, Koldas, Lale, Karpenko, Oleksandr, Prokhorov, Alexander, Vakaluyk, Ihor, Myshanych, Halyna, Reshotko, Dmytro, Batushkin, Valeriy, Rudenko, Leonid, Kovalskyi, Ihor, Kushnir, Mykola, Tseluyko, Vira, Mostovoy, Yuriy, Stanislavchuk, Mykola, Kyiak, Yulian, Karpenko, Yuriy, Malynovsky, Yaroslav, Klantsa, Andriy, Kutniy, Oles, Amosova, Ekaterina, Tashchuk, Viktor, Leshchuk, Oleh, Parkhomenko, Alexander, Rishko, Mykola, Kopytsya, Mykola, Yagensky, Andriy, Vatutin, Mykola, Bagriy, Andriy, Barna, Olga M, Ushakov, Olexiy, Dzyak, Georgiy, Goloborodko, Borys, Rudenko, Anatolii, Zheleznyy, Volodymyr, Trevelyan, Jasper, Zaman, Azfar, Lee, Kaeng, Moriarty, Andrew, Aggarwal, Rajesh K, Clifford, Piers, Wong, Yuk- Ki, Iqbal, Syed MR, Subkovas, Eduardas, Braganza, Denise, Sarkar, David, Storey, Robert, Griffiths, Huw, Mcclure, Sam, Muthusamy, Rangasamy, Smith, Simon, Kurian, John, Levy, Terry, Barr, Craig, Kadr, Honer, Gerber, Robert, Simaitis, Audrius, Soran, Handrean, Brodison, Adrian, Ayaz, Mohammad, Cheema, Muhammad, Oliver, Richard, Thackray, Simon, Mudawi, Telal, Rahma, Gohar, Sultan, Ayyaz, Reynolds, Timothy, Sharman, David, Spriging, david, Butler, Rob, Wilkinson, Peter, Lip, Gregory YH, Ossei-Gerning, Nicholas, Vardi, Gil, Baldari, Duccio, Brabham, David, Treasure II, Charles, Dahl, Charles, Palmer, Bruce, Wiseman, Alan, Khan, Abul, Puri, Sanjeev, Mohart, Ann Elizabeth, Ince, Carlos, Flores, Enrique, Wright, Scott, Cheng, Shi-Chi, Rosenberg, Michael, Rogers, William, Kosinski, Edward, Forgosh, Les, Waltman, Jonathan, Shoukfeh, Mohammad, Dagher, Georges, Cambier, Patrick, Lieber, Ira, Kumar, Priya, East, Cara, Krichmar, Perry, Hasan, Mian, White, Lindsey, Knickelbine, Thomas, Haldis, Thomas, Gillespie, Eve, Amidon, Thomas, Suh, David, Arif, Imran, Abdallah, mouhamad, Akhter, Faiq, Carlson, Eric, D’Urso, Michael, El- Ahdab, Fadi, Nelson, William, Moriarty, Katie, Harris, Barry, Cohen, Steven, Carter, Luther, Doty, Daniel, Sabatino, Kenneth, Haddad, Tariq, Rao, Sunder, Mulkay, Angel, Jovin, Ion, Klancke, Kim, Malhotra, Vinay, Devarapalli, Sai K, Koren, Michael, Chandna, Harish, Dodds, George, Goraya, Tauqir, Bengston, James, Janik, Matthew, Moran, Joseph, Sumner, Andrew, Kobayashi, John, Davis, William, Yazdani, Shahram, Pasquini, John, Thakkar, Maitreya, Vedere, Amarnath, Leimbach, Wayne, Rider, James, fenton, Sarah, Singh, Narendra, Shah, Anil V, Moriarty, Patrick M., Janosik, Denise, Pepine, Carl, Berman, Brett, Gelormini, Joseph, Daniels, Christopher, Richard, Kerensky, Keating, Friederike, Kondo, Nicholas I, Shetty, Sanjay, Levite, Howard, Waider, Winfried, Takata, Theodore, Abu-Fadel, Mazen, Shah, Vipul, Aggarwal, Rahul, Kumar, Anil, Hattler, Brack, Do, Rose, Link, Chad, Bortnick, Anna, Kinzfogl, George, Ghitis, Arnold, Larry, John, Teufel, Edward, Kuhlman, Peter, Mclaurin, Brent, Zhang, Wenwu, Thew, Stephen, Abbas, Jalal, White, Matthew, Islam, Othman, Subherwal, Sumeet, Ranadive, Nandkishore, Vakili, Babak, Gring, Christian, Henderson, David, Schuchard, Timothy, Farhat, Naim, Kline, Geoffrey, Mahal, Sharan, Whitaker, Jack, Speirs, Shawn, Andersen, Rolf, Daboul, Nizar, Horwitz, Phillip, Zahr, Firas, Ponce, George, Jafar, Zubair, Mcgarvey, Joseph, Panchal, Vipul, Voyce, Stephen, Blok, Thomas, Sheldon, William, Azizad, Masoud M, Schmalfuss, Carsten, Picone, Mark, Pederson, Robert, Herzog, William, Friedman, Keith, Lindsey, Jason, Timothy, Eichenlaub, Leonard, Parilak, Lepor, Norman, El Shahawy, Mahfouz, Weintraub, Howard, Irimpen, Anand, Alonso, Alvaro, May, Wade, Christopher, Daniels, Galski, Thomas, Chu, Alan, Mody, Freny, Ramin, Ebrahimi, Hodes, Zachary, Rossi, Joseph, Rose, Gregory, Fairlamb, James, Lambert, Charles, Raisinghani, Ajit, Abbate, Antonio, Vetrovec, George, King, Marilyn, Carey, Charles, Gerber, Jaime, Younis, Liwa, Park, Hyeun (Tom), Vidovich, Mladen, Knutson, Thomas, Friedman, Dennis, Chaleff, Fred, Loussararian, Arthur, Rozeman, Phillip, Kimmelstiel, Carey, Kuvin, Jeffrey, Silver, Kevin, Foster, Malcolm, Tonnessen, Glen, Espinoza, Andrey, Amlani, Mohamadali, Wali, Andreas, Malozzi, Christopher, Jong, Geert T, Massey, Clara, Wattanakit, Keattiyoat, O’Donnell, Philip J., Singal, Dinesh, Jaffrani, Naseem, Banuru, Sridhar, Fisher, Daniel, Xenakis, Mark, Perlmutter, Neal, Bhagwat, Ravi, Strader, James, Blonder, Ronald, Akyea-Djamson, Ayim, Labroo, Ajay, Lee, Kwan, Marais, H. John, Claxton, Edmund, Weiss, Robert, Kathryn, Rohr, Berk, Martin, Rossi, Peter, Joshi, Parag, Khera, Amit, Khaira, Ajit S, Kumkumian, Greg, Lupovitch, Steven, Purow, Joshua, Welka, Stephen, Hoffman, David, Fischer, Stuart, Soroka, Eugene, Eagerton, Donald, Pancholy, Samir, Ray, Michael, Erenrich, Norman, Farrar, Michael, Pollock, Stewart, French, William J, Diamantis, Steve, Guy, Douglas, Gimple, Lawrence, Neustel, Mark, Schwartz, Steven, Pereira, Edward, Albert, Seals, Spriggs, Douglas, Strain, Janet, Mittal, Suneet, Vo, Anthony, Chane, Majed, Hall, Jason, Vijay, Nampalli, Lotun, Kapildeo, Lester, F. Martin, Nahhas, Ahed, Pope, Theodore, Nager, Paul, Vohra, Rakesh, Sharma, Mukesh, Bashir, Riyaz, Ahmed, Hinan, Berlowitz, Michael, Fishberg, Robert, Barrucco, Robert, Yang, Eric, Radin, Michael, Sporn, Daniel, Stapleton, Dwight, Eisenberg, Steven, Landzberg, Joel, Mcgough, Martin, Turk, Samir, Schwartz, Michael, Sundram, P. Sandy, Jain, Diwakar, Zainea, Mark, Bayron, Carlos, Karlsberg, Ronald, Dohad, Suhail, Lui, Henry, Keen, William, Westerhausen, Donald, Khurana, Sandeep, Agarwal, Himanshu, Birchem, Jessica, Penny, William, Chang, Mark, Murphy, Sherrill, Henry, John, Schifferdecker, Branislav, Gilbert, John M, Chalavarya, Gopal, Eaton, Charles, Schmedtje, John F, Christenson, Stuart, Dotani, Imran, Denham, Douglas, Macdonell, Alexander, Gibson, Paul, Rahman, Aref, Al Joundi, Tammam, Assi, Nizar, Conrad, Gary, Kotha, Purushotham, Love, Michael, Giesler, Gregory, Rubenstein, Howard, Gamil, Dawood, Akright, Laura, Krawczyk, Justine, Cobler, Joanne, Wells, Terry, Welker, James, Foster, Robert, Gilmore, Richard, Anderson, Jay, Jacoby, Douglas, Harris, Bill, Gardner, Geraldine, Dandillaya, Ramprasad, Vora, Kishor, Kostis, John, Hunter, John, Laxson, David, Ball, Eric, Anderson, Jay, Wells, Terry, Vora, Kishor, Ball, Eric, Welker, James, Lopes, Renato D., Egydio, Flavia, Kawakami, Anelise, Oliveira, Janaina, Goodman, Shaun G., Wozniak, Julianna, Matthews, Alexander, Ratky, Caroline, Valiris, Janine, Berdan, Lisa, Hepditch, Anita, Quintero, Kirby, Roe, Matthew T., Rorick, Tyrus, Westbrook, Melissa, Danchin, Nicolas, Bezault, Madeleine, Drouet, Elodie, Simon, Tabassome, White, Harvey D., Alsweiler, Caroline, Sinnaeve, Peter, Luyten, Anne, Aylward, Philip E, Butters, Julie, Griffith, Liddy, Shaw, Michelle, Hagström, Emil, Grunberg, Lena, Szarek, Michael, Islam, Shahidul, Brégeault, Marie-France, Bougon, Nathalie, Faustino, Douglas, Fontecave, Sylvie, Murphy, Judith, Tamby, Jean- Francois, Verrier, Melanie, Agnetti, Veronique, Andersen, Dorthe, Badreddine, Emmy, Bekkouche, Mhamed, Bouancheau, Cecile, Brigui, Imane, Brocklehurst, Maddy, Cianciarulo, Joseph, Devaul, Dawn, Domokos, Szilvia, Gache, Cecile, Gobillot, Caroline, Guillou, Severine, Healy, Jan, Heath, Megan, Jaiwal, Gayatri, Javierre, Carine, Labeirie, Julien, Monier, Myriam, Morales, Ulises, Mrabti, Asmaa, Mthombeni, Bicky, Okan, Betim, Smith, Lucile, Sheller, Jennifer, Sopena, Sebastien, Pellan, Valerie, Benbernou, Fadela, Bengrait, Nafissa, Lamoureux, Maud, Kralova, Katarina, Scemama, Michel, Bejuit, Raphael, Coulange, Anthony, Berthou, Christelle, Repincay, Jérôme, Lorenzato, Christelle, Etienne, Alexis, Gouet, Valerie, Lecorps, Guillaume, Loizeau, Virginie, Normand, Mickael, Ourliac, Anne, Rondel, Christelle, Adamo, Antony, Beltran, Pascale, Barraud, Pauline, Dubois-Gache, Helene, Halle, Benjamin, Metwally, Lamia, Mourgues, Maxime, Sotty, Marc, Vincendet, Marion, Cotruta, Raluca, Chengyue, Zhu, Fournie-Lloret, Dominique, Morrello, Christine, Perthuis, Aurelie, Picault, Patrick, Zobouyan, Isabelle, Colhoun, Helen M., Dempsey, Michael A., and McClanahan, Mark A.
Published: 2022
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16. Long‐Term Mortality of Older Patients With Acute Myocardial Infarction Treated in US Clinical Practice

Author: Kochar, Ajar, Chen, Anita Y, Sharma, Puza P, Pagidipati, Neha J, Fonarow, Gregg C, Cowper, Patricia A, Roe, Matthew T, Peterson, Eric D, and Wang, Tracy Y
Subjects: Aging, Heart Disease - Coronary Heart Disease, Patient Safety, Heart Disease, Cardiovascular, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Age Factors, Aged, Aged, 80 and over, Cardiovascular Agents, Female, Humans, Male, Medicare, Myocardial Revascularization, Non-ST Elevated Myocardial Infarction, Registries, Retrospective Studies, Risk Assessment, Risk Factors, ST Elevation Myocardial Infarction, Time Factors, Treatment Outcome, United States, elderly, mortality, myocardial infarction, revascularization, survival, Cardiorespiratory Medicine and Haematology
Abstract: BackgroundThere is limited information about the long-term survival of older patients after myocardial infarction (MI).Methods and resultsCRUSADE (Can rapid risk stratification of unstable angina patients suppress adverse outcomes with early implementation of the ACC/AHA guidelines) was a registry of MI patients treated at 568 US hospitals from 2001 to 2006. We linked MI patients aged ≥65 years in CRUSADE to their Medicare data to ascertain long-term mortality (defined as 8 years post index event). Long-term unadjusted Kaplan-Meier mortality curves were examined among patients stratified by revascularization status. A landmark analysis conditioned on surviving the first year post-MI was conducted. We used multivariable Cox regression to compare mortality risks between ST-segment-elevation myocardial infarction and non-ST-segment-elevation myocardial infarction patients. Among 22 295 MI patients ≥ age 65 years (median age 77 years), we observed high rates of evidence-based medication use at discharge: aspirin 95%, β-blockers 94%, and statins 81%. Despite this, mortality rates were high: 24% at 1 year, 51% at 5 years, and 65% at 8 years. Eight-year mortality remained high among patients who underwent percutaneous coronary intervention (49%), coronary artery bypass graft (46%), and among patients who survived the first year post-MI (59%). Median survival was 4.8 years (25th, 75th percentiles 1.1, 8.5); among patients aged 65-74 years it was 8.2 years (3.3, 8.9) while for patients aged ≥75 years it was 3.1 years (0.6, 7.6). Eight-year mortality was lower among ST-segment-elevation myocardial infarction than non-ST-segment-elevation myocardial infarction patients (53% versus 67%); this difference was not significant after adjustment (hazard ratio 0.94, 95% confidence interval, 0.88-1.00).ConclusionsLong-term mortality remains high among patients with MI in routine clinical practice, even among revascularized patients and those who survived the first year.
Published: 2018

17. Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial

Author: Schwartz, Gregory G., Steg, Ph. Gabriel, Bhatt, Deepak L., Bittner, Vera A., Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Szarek, Michael, White, Harvey D., Zeiher, Andreas M., Tricoci, Pierluigi, Roe, Matthew T., Mahaffey, Kenneth W., Edelberg, Jay M., Hanotin, Corinne, Lecorps, Guillaume, Moryusef, Angèle, Pordy, Robert, 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, Viigimaa, Margus, Nieminen, Markku S., Chumburidze, Vakhtang, Marx, Nikolaus, Danchin, Nicolas, Liberopoulos, Evangelos, Montenegro Valdovinos, Pablo Carlos, 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, Ramos López, Gabriel Arturo, Alings, Marco, Halvorsen, Sigrun, Correa Flores, Roger M., 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., Vogel, Robert, Chaitman, Bernard, Kelsey, Sheryl F., Olsson, Anders G., Rouleau, Jean-Lucien, Simoons, Maarten L., Alexander, Karen, Meloni, Chiara, Rosenson, Robert, Sijbrands, Eric J.G., Alexander, John H., Armaganijan, Luciana, Bagai, Akshay, Bahit, Maria Cecilia, Brennan, J. Matthew, Clifton, Shaun, DeVore, Adam D., Deloatch, Shalonda, Dickey, Sheila, Dombrowski, Keith, Ducrocq, Grégory, Eapen, Zubin, Endsley, Patricia, Eppinger, Arleen, Harrison, Robert W., Hess, Connie Ng, Hlatky, Mark A., Jordan, Joseph Dedrick, Knowles, Joshua W., Kolls, Bradley J., Kong, David F., Leonardi, Sergio, Lillis, Linda, Maron, David J., Marcus, Jill, Mathews, Robin, Mehta, Rajendra H., Mentz, Robert J., Moreira, Humberto Graner, Patel, Chetan B., Bernardez-Pereira, Sabrina, Perkins, Lynn, Povsic, Thomas J., Puymirat, Etienne, Schuyler Jones, William, Shah, Bimal R., Sherwood, Matthew W., Stringfellow, Kenya, Sujjavanich, Darin, Toma, Mustafa, Trotter, Charlene, Van Diepen, Sean, Wilson, Matthew D., Yan, Andrew T., Schiavi, Lilia B., Garrido, Marcelo, Alvarisqueta, Andrés F., Sassone, Sonia A., Bordonava, Anselmo P., Alves De Lima, Alberto E., Schmidberg, Jorge M., Duronto, Ernesto A., Caruso, Orlando C., Novaretto, Leonardo P., Hominal, Miguel Angel, Montaña, Oscar R., 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Renato, Kormann, Adrian, Abrantes, José Antonio M, Pimentel Filho, Pedro, Soggia, Ana Priscila, de Santos, Mayler ON, Neuenschwander, Fernando, Bodanese, Luiz C, Michalaros, Yorghos L, Eliaschewitz, Freddy G, Vidotti, Maria H, Leaes, Paulo E, Botelho, Roberto V, Kaiser, Sergio, Manenti, Euler Roberto Fernandes, Precoma, Dalton B, Moura Jorge, Jose C, de B Silva, Pedro G, Silveira, Jose A, Saporito, Wladmir, Marin-Neto, Jose A, Feitosa, Gilson S, Ritt, Luiz Eduardo F, de Souza, Juliana A, Costa, Fernando, Souza, Weimar KSB, Reis, Helder JL, Machado, Leandro, Ayoub, José Carlos Aidar, Todorov, Georgi V, Nikolov, Fedya P, Velcheva, Elena S, Tzekova, Maria L, Benov, Haralambi O, Petranov, Stanislav L, Tumbev, Haralin S, Shehova-Yankova, Nina S, Markov, Dimitar T, Raev, Dimitar H, Mollov, Mihail N, Kichukov, Kostadin N, Ilieva-Pandeva, Katya A, Ivanova, Raya, Gospodinov, Maryana, Mincheva, Valentina M, Lazov, Petar V, Dimov, Bojidar I, Senaratne, Manohara, Stone, James, Kornder, Jan, 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Published: 2019
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18. Lipoprotein(a) and Benefit of PCSK9 Inhibition in Patients With Nominally Controlled LDL Cholesterol

Author: Schwartz, Gregory G., Gabriel Steg, P.h., Bhatt, Deepak L., Bittner, Vera A., Diaz, Rafael, Goodman, Shaun G., Harrington, Robert A., Jukema, J. Wouter, Szarek, Michael, White, Harvey D., Zeiher, Andreas M., Tricoci, Pierluigi, Roe, Matthew T., Mahaffey, Kenneth W., Edelberg, Jay M., Hanotin, Corinne, Lecorps, Guillaume, Moryusef, Angèle, Pordy, Robert, 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, Montenegro Valdovinos, Pablo Carlos, 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, Ramos López, Gabriel Arturo, Alings, Marco, Halvorsen, Sigrun, Correa Flores, Roger M., 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, Asita de Silva, H., Hagström, Emil, Landmesser, Ulf, Müller, Christian, Chiang, Chern-En, Sritara, Piyamitr, Guneri, Sema, Parkhomenko, Alexander, Ray, Kausik K., Moriarty, Patrick M., Vogel, Robert, Chaitman, Bernard, Kelsey, Sheryl F., Olsson, Anders G., Rouleau, Jean-Lucien, Simoons, Maarten L., Alexander, Karen, Meloni, Chiara, Rosenson, Robert, Sijbrands, Eric J.G., Alexander, John H., Armaganijan, Luciana, Bagai, Akshay, Bahit, Maria Cecilia, Brennan, J. Matthew, Clifton, Shaun, DeVore, Adam D., Deloatch, Shalonda, Dickey, Sheila, Dombrowski, Keith, Ducrocq, Grégory, Eapen, Zubin, Endsley, Patricia, Eppinger, Arleen, Harrison, Robert W., Hess, Connie Ng, Hlatky, Mark A., Jordan, Joseph Dedrick, Knowles, Joshua W., Kolls, Bradley J., Kong, David F., Leonardi, Sergio, Lillis, Linda, Maron, David J., Marcus, Jill, Mathews, Robin, Mehta, Rajendra H., Mentz, Robert J., Moreira, Humberto Graner, Patel, Chetan B., Pereira, Sabrina Bernardez, Perkins, Lynn, Povsic, Thomas J., Puymirat, Etienne, Jones, William Schuyler, Shah, Bimal R., Sherwood, Matthew W., Stringfellow, Kenya, Sujjavanich, Darin, Toma, Mustafa, Trotter, Charlene, van Diepen, Sean F.P., Wilson, Matthew D., Tze-Kay Yan, Andrew, Schiavi, Lilia B., Garrido, Marcelo, Alvarisqueta, Andrés F., Sassone, Sonia A., Bordonava, Anselmo P., Alves De Lima, Alberto E., Schmidberg, Jorge M., Duronto, Ernesto A., Caruso, Orlando C., Novaretto, Leonardo P., Hominal, Miguel Angel, Montaña, Oscar 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Cadena Bonfanti, Alberto J., Aroca, Carlos Cotes, Higuera, Juan Diego, Blanquicett, Marco, Barrera Silva, Sandra I., Garcia Lozada, Henry J., Coronel Arroyo, Julian A., Accini Mendoza, Jose L., Fernandez Ruiz, Ricardo L., Quintero Ossa, Alvaro M., Manzur Jatin, Fernando G., Herazo, Aristides Sotomayor, Parada, Jeffrey Castellanos, Arambula, Rafael Suarez, Urina Triana, Miguel A., Fernandez Trujillo, Angela M., Strozzi, Maja, Car, Siniša, Jerić, Melita, Miličić, Davor, Benčić, Martina Lovrić, Pintarić, Hrvoje, Prvulović, Đeiti, Šikić, Jozica, Peršić, Viktor, Mileta, Dean, Štambuk, Kresimir, Babić, Zdravko, Tomulic, Vjekoslav, Lukenda, Josip, Mejic-Krstulovic, Stanka, Starcevic, Boris, Spinar, Jindrich, Horak, David, Velicka, Zdenek, Stasek, Josef, Alan, David, Machova, Vilma, Linhart, Ales, Novotny, Vojtech, Kaucak, Vladimir, Rokyta, Richard, Naplava, Robert, Coufal, Zdenek, Adamkova, Vera, Podpera, Ivo, Zizka, Jiri, Motovska, Zuzana, Marusincova, Ivana, Svab, Premysl, Heinc, Petr, 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Published: 2021
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19. Abstract 14286: Comparison of Enteric Coated Aspirin With Plain Aspirin on Effectiveness and Safety in the ADAPTABLE Trial

Author: Effron, Mark B, Sleem, Amber, Stebbins, Amanda, Wruck, Lisa M, Gravel, Guillaume, Muñoz, Daniel, Re, Richard N, gupta, Kamal, Pepine, Carl, Jain, Sandeep, Girotra, Saket, Whittle, Jeffrey, Benziger, Catherine, Farrehi, Peter M, Knowlton, Kirk U, Polonsky, Tamar S, Roe, Matthew T, Rothman, Russell T, Harrington, Robert A, Jones, William S, and Hernandez, Adrian F
Published: 2022
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20. Abstract 14192: Effect of Aspirin Dosing in Patients Treated With P2Y12 Inhibitors for Secondary Prevention of Cardiovascular Events

Author: Girotra, Saket, Stebbins, Amanda, Wruck, Lisa M, Riley, Danielle, Kripalani, Sunil, Munoz, Daniel, Effron, Mark B, gupta, Kamal, Whittle, Jeffrey, Benziger, Catherine, Zhou, Li, Farrehi, Peter M, Polonsky, Tamar S, Ahmad, Faraz S, Roe, Matthew T, Rothman, Russell, Harrington, Robert A, Hernandez, Adrian F, and Jones, William S
Published: 2022
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21. Abstract 13803: Contribution of Clinical Trial Event Data by Data Source: Insights From the ADAPTABLE Trial

Author: Rymer, Jennifer A, Mulder, Hillary, Wruck, Lisa M, Munoz, Daniel, Kripalani, Sunil, Effron, Mark B, gupta, Kamal, Handberg, Eileen M, Jain, Sandeep, Girotra, Saket, Whittle, Jeffrey, Hess, Rachel, Benziger, Catherine, Knowlton, Kirk U, Curtis, Lesley, Roe, Matthew T, Hammill, Bradley G, Rothman, Russell, Harrington, Josephine, Hernandez, Adrian F, and Jones, William
Published: 2022
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22. More Versus Better: Learning From the Medtronic Valiant Navion Recall

Author: Weissler, E. Hope, Roe, Matthew, Hammill, Bradley G., and Hughes, G. Chad
Published: 2022
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23. Post-COVID-19 Syndrome: Leveraging the Patient Perspective and Technological Innovations to Enable the Delineation of Effective Treatments

Author: Roe, Matthew T., Patrick-Lake, Bray, and von Eschenbach, Andrew C.
Published: 2021
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24. Comparison of Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction With Versus Without Hyperuricemia or Gout

Author: Carnicelli, Anthony P., Clare, Robert, Chiswell, Karen, Lytle, Barbara, Bjursell, Magnus, Perl, Shira, Andersson, Karolina, Hedman, Katarina, Pagidipati, Neha, Vemulapalli, Sreekanth, Roe, Matthew T., and Mentz, Robert J.
Published: 2020
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25. Meta-Analysis of Intraocular Bleeding With Dual Antiplatelet Therapy Using P2Y12 Inhibitors Prasugrel or Ticagrelor

Author: Sun, Michelle T., Huang, Sonia, Wiviott, Stephen D., Antman, Elliot M., Roe, Matthew T., Ohman, E. Magnus, Neely, Megan, Wallentin, Lars, and Wong, Christopher X.
Published: 2020
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26. Targeting Vascular Calcification in Chronic Kidney Disease

Author: Nelson, Adam J., Raggi, Paolo, Wolf, Myles, Gold, Alexander M., Chertow, Glenn M., and Roe, Matthew T.
Published: 2020
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27. Continued investigator engagement: Reasons principal investigators conduct multiple FDA-regulated drug trials

Author: Dombeck, Carrie B., Hinkley, Terri, Fordyce, Christopher B., Blanchard, Katelyn, Roe, Matthew T., and Corneli, Amy
Published: 2020
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28. Effectiveness and Safety of Enteric-Coated vs Uncoated Aspirin in Patients With Cardiovascular Disease

Author: Sleem, Amber, primary, Effron, Mark B., additional, Stebbins, Amanda, additional, Wruck, Lisa M., additional, Marquis-Gravel, Guillaume, additional, Muñoz, Daniel, additional, Re, Richard N., additional, Gupta, Kamal, additional, Pepine, Carl J., additional, Jain, Sandeep K., additional, Girotra, Saket, additional, Whittle, Jeffrey, additional, Benziger, Catherine P., additional, Farrehi, Peter M., additional, Knowlton, Kirk U., additional, Polonsky, Tamar S., additional, Roe, Matthew T., additional, Rothman, Russell L., additional, Harrington, Robert A., additional, Jones, W. Schuyler, additional, and Hernandez, Adrian F., additional
Published: 2023
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29. Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Patients Treated With P2Y12 Inhibitors

Author: Girotra, Saket, primary, Stebbins, Amanda, additional, Wruck, Lisa, additional, Marquis‐Gravel, Guillaume, additional, Gupta, Kamal, additional, Farrehi, Peter, additional, Benziger, Catherine P., additional, Effron, Mark B., additional, Whittle, Jeffrey, additional, Muñoz, Daniel, additional, Kripalani, Sunil, additional, Anderson, R. David, additional, Jain, Sandeep K., additional, Polonsky, Tamar S., additional, Ahmad, Faraz S., additional, Roe, Matthew T., additional, Rothman, Russell L., additional, Harrington, Robert A., additional, Hernandez, Adrian F., additional, and Jones, W. Schuyler, additional
Published: 2023
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30. Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting

Author: Lentz, Trevor A., Curtis, Lesley H., Rockhold, Frank W., Martin, David, Andersson, Tomas L. G., Arias, Carolyn, Berlin, Jesse A., Binns, Cherie, Cook, Andrea, Cziraky, Mark, Dent, Ricardo, Desai, Manisha, Emmett, Andrew, Esserman, Denise, George, Jyothis, Hantel, Stefan, Heagerty, Patrick, Hernandez, Adrian F., Hucko, Thomas, Khan, Naeem, Lee, Shun Fu, LoCasale, Robert, Mardekian, Jack, McCall, Debbe, Monda, Keri, Normand, Sharon-Lise, Riesmeyer, Jeffrey, Roe, Matthew, Roessig, Lothar, Scott, Rob, Siedentop, Harald, Waldstreicher, Joanne, Wang, Lin, Weerakkody, Govinda, Wolf, Myles, and Ellenberg, Susan S.
Published: 2020
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31. Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials

Author: Coles, Theresa M., Hernandez, Adrian F., Reeve, Bryce B., Cook, Karon, Edwards, Michael C., Boutin, Marc, Bush, Elizabeth, Degboe, Arnold, Roessig, Lothar, Rudolph, Amy, McNulty, Pauline, Patel, Nikunj, Kay-Mugford, Trish, Vernon, Margaret, Woloschak, Michael, Buchele, Gustavo, Spertus, John A., Roe, Matthew T., Bury, Denise, and Weinfurt, Kevin
Published: 2021
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32. The role of machine learning in clinical research: transforming the future of evidence generation

Author: Weissler, E. Hope, Naumann, Tristan, Andersson, Tomas, Ranganath, Rajesh, Elemento, Olivier, Luo, Yuan, Freitag, Daniel F., Benoit, James, Hughes, Michael C., Khan, Faisal, Slater, Paul, Shameer, Khader, Roe, Matthew, Hutchison, Emmette, Kollins, Scott H., Broedl, Uli, Meng, Zhaoling, Wong, Jennifer L., Curtis, Lesley, Huang, Erich, and Ghassemi, Marzyeh
Published: 2021
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33. Correction to: The role of machine learning in clinical research: transforming the future of evidence generation

Author: Weissler, E. Hope, Naumann, Tristan, Andersson, Tomas, Ranganath, Rajesh, Elemento, Olivier, Luo, Yuan, Freitag, Daniel F., Benoit, James, Hughes, Michael C., Khan, Faisal, Slater, Paul, Shameer, Khader, Roe, Matthew, Hutchison, Emmette, Kollins, Scott H., Broedl, Uli, Meng, Zhaoling, Wong, Jennifer L., Curtis, Lesley, Huang, Erich, and Ghassemi, Marzyeh
Published: 2021
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34. Longitudinal low density lipoprotein cholesterol goal achievement and cardiovascular outcomes among adult patients with familial hypercholesterolemia: The CASCADE FH registry

Author: Duell, P. Barton, Gidding, Samuel S., Andersen, Rolf L., Knickelbine, Thomas, Anderson, Lars, Gianos, Eugenia, Shrader, Peter, Kindt, Iris, O'Brien, Emily C., McCann, Dervilla, Hemphill, Linda C., Ahmed, Catherine D., Martin, Seth S., Larry, John A., Ahmad, Zahid S., Kullo, Iftikhar J., Underberg, James A., Guyton, John, Thompson, Paul, Wilemon, Katherine, Roe, Matthew T., Rader, Daniel J., Cuchel, Marina, Linton, MacRae F., Shapiro, Michael D., Moriarty, Patrick M., and Knowles, Joshua W.
Published: 2019
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35. Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery

Author: Goodman, Shaun G., Aylward, Philip E., Szarek, Michael, Chumburidze, Vakhtang, Bhatt, Deepak L., Bittner, Vera A., Diaz, Rafael, Edelberg, Jay M., Hanotin, Corinne, Harrington, Robert A., Jukema, J. Wouter, Kedev, Sasko, Letierce, Alexia, Moryusef, Angele, Pordy, Robert, Ramos López, Gabriel Arturo, Roe, Matthew T., Viigimaa, Margus, White, Harvey D., Zeiher, Andreas M., Steg, Ph. Gabriel, and Schwartz, Gregory G.
Published: 2019
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36. Alirocumab in Patients With Polyvascular Disease and Recent Acute Coronary Syndrome: ODYSSEY OUTCOMES Trial

Author: Jukema, J. Wouter, Szarek, Michael, Zijlstra, Laurien E., de Silva, H. Asita, Bhatt, Deepak L., Bittner, Vera A., Diaz, Rafael, Edelberg, Jay M., Goodman, Shaun G., Hanotin, Corinne, Harrington, Robert A., Karpov, Yuri, Moryusef, Angèle, Pordy, Robert, Prieto, Juan C., Roe, Matthew T., White, Harvey D., Zeiher, Andreas M., Schwartz, Gregory G., and Steg, P. Gabriel
Published: 2019
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37. Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database

Author: Fordyce, Christopher B., Roe, Matthew T., Pierre, Christine, Hinkley, Terri, Hamre, Gerrit, Tenaerts, Pamela, McCall, Jonathan, and Topping, James D.
Published: 2019
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38. Patient Phenotypes, Cardiovascular Risk, and Ezetimibe Treatment in Patients After Acute Coronary Syndromes (from IMPROVE-IT)

Author: Sharma, Abhinav, Sun, Jie-Lena, Lokhnygina, Yuliya, Roe, Matthew T., Ahmad, Tariq, Desai, Nihar R., and Blazing, Michael A.
Published: 2019
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39. Sex And Prognostic Significance of Self-Reported Frailty in Non–ST-Segment Elevation Acute Coronary Syndromes: Insights From the TRILOGY ACS Trial

Author: Kaul, Padma, Alexander, Karen P., Ohman, E. Magnus, Savu, Anamaria, Roe, Matthew T., Goodman, Shaun G., Fox, Keith A., White, Harvey D., Prabhakaran, Dorairaj, Hochman, Judith S., Clemmensen, Peter, and Armstrong, Paul W.
Published: 2019
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40. Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events: The ODYSSEY OUTCOMES Trial

Author: Szarek, Michael, White, Harvey D., Schwartz, Gregory G., Alings, Marco, Bhatt, Deepak L., Bittner, Vera A., Chiang, Chern-En, Diaz, Rafael, Edelberg, Jay M., Goodman, Shaun G., Hanotin, Corinne, Harrington, Robert A., Jukema, J. Wouter, Kimura, Takeshi, Kiss, Robert Gabor, Lecorps, Guillaume, Mahaffey, Kenneth W., Moryusef, Angèle, Pordy, Robert, Roe, Matthew T., Tricoci, Pierluigi, Xavier, Denis, Zeiher, Andreas M., and Steg, Ph. Gabriel
Published: 2019
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41. Improving and Sustaining the Site Investigator Community: Recommendations from the Clinical Trials Transformation Initiative

Author: Fordyce, Christopher B., Malone, Kaitlin, Forrest, Annemarie, Hinkley, Terri, Corneli, Amy, Topping, James, and Roe, Matthew T.
Published: 2019
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42. Validation of Cardiovascular End Points Ascertainment Leveraging Multisource Electronic Health Records Harmonized Into a Common Data Model in the ADAPTABLE Randomized Clinical Trial

Author: Marquis-Gravel, Guillaume, Hammill, Bradley G., Mulder, Hillary, Roe, Matthew T., Robertson, Holly R., Wruck, Lisa M., Sharlow, Amber, Harris, Debra F., Pohlman, F. Will, Hernandez, Adrian F., and Jones, W. Schuyler
Published: 2021
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43. Natural History of Patients Postacute Coronary Syndrome Based on Heart Failure Status

Author: Ambrosy, Andrew P., Cerbin, Lukasz P., Fudim, Marat, Clare, Robert M., Lokhnygina, Yuliya, Braunwald, Eugene, Califf, Robert M., Cannon, Christopher P., Tershakovec, Andrew M., Roe, Matthew T., and Blazing, Michael A.
Published: 2018
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44. Outcomes of Patients Receiving Downstream Revascularization After Initial Medical Management for Non–ST-Segment Elevation Acute Coronary Syndromes (From the TRILOGY ACS Trial)

Author: Hinohara, Tomoya T., Roe, Matthew T., White, Harvey D., Fox, Keith A.A., Bhatt, Deepak L., Hamm, Christian, Gurbel, Paul A., Aylward, Philip E., Wiviott, Stephen D., Huber, Kurt, Neely, Megan L., and Ohman, E. Magnus
Published: 2018
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45. Age and Aspirin Dosing in Secondary Prevention of Atherosclerotic Cardiovascular Disease.

Author: Marquis-Gravel, Guillaume, Stebbins, Amanda, Wruck, Lisa M., Roe, Matthew T., Effron, Mark B., Hammill, Bradley G., Whittle, Jeff, VanWormer, Jeffrey J., Robertson, Holly R., Alikhaani, Jacqueline D., Kripalani, Sunil, Farrehi, Peter M., Girotra, Saket, Benziger, Catherine P., Polonsky, Tamar S., Merritt, J. Greg, Gupta, Kamal, McCormick III, Thomas E., Knowlton, Kirk U., and Jain, Sandeep K.
Published: 2024
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46. Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease and Diabetes Mellitus: A Subgroup Analysis of the ADAPTABLE Trial.

Author: Narcisse, Dennis I., Kim, Hwasoon, Wruck, Lisa M., Stebbins, Amanda L., Muñoz, Daniel, Kripalani, Sunil, Effron, Mark B., Gupta, Kamal, Anderson, R. David, Jain, Sandeep K., Girotra, Saket, Whittle, Jeff, Benziger, Catherine P., Farrehi, Peter, Zhou, Li, Polonsky, Tamar S., Ahmad, Faraz S., Roe, Matthew T., Rothman, Russell L., and Harrington, Robert A.
Abstract: OBJECTIVE: Patients with diabetes mellitus (DM) and concomitant atherosclerotic cardiovascular disease (ASCVD) must be on the most effective dose of aspirin to mitigate risk of future adverse cardiovascular events. RESEARCH DESIGN AND METHODS: ADAPTABLE, an open-label, pragmatic study, randomized patients with stable, chronic ASCVD to 81 mg or 325 mg of daily aspirin. The effects of aspirin dosing was assessed on the primary effectiveness outcome, a composite of all-cause death, hospitalization for myocardial infarction, or hospitalization for stroke, and the primary safety outcome of hospitalization for major bleeding. In this prespecified analysis, we used Cox proportional hazards models to compare aspirin dosing in patients with and without DM for the primary effectiveness and safety outcome. RESULTS: Of 15,076 patients, 5,676 (39%) had DM of whom 2,820 (49.7%) were assigned to 81 mg aspirin and 2,856 (50.3%) to 325 mg aspirin. Patients with versus without DM had higher rates of the composite cardiovascular outcome (9.6% vs. 5.9%; P < 0.001) and bleeding events (0.78% vs. 0.50%; P < 0.001). When comparing 81 mg vs. 325 mg of aspirin, patients with DM had no difference in the primary effectiveness outcome (9.3% vs. 10.0%; hazard ratio [HR] 0.98 [95% CI 0.83–1.16]; P = 0.265) or safety outcome (0.87% vs. 0.69%; subdistribution HR 1.25 [95% CI 0.72–2.16]; P = 0.772). CONCLUSIONS: This study confirms the inherently higher risk of patients with DM irrespective of aspirin dosing. Our findings suggest that a higher dose of aspirin yields no added clinical benefit, even in a more vulnerable population. [ABSTRACT FROM AUTHOR]
Published: 2024
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47. Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease and Diabetes Mellitus: A Subgroup Analysis of the ADAPTABLE Trial

Author: Narcisse, Dennis I, primary, Kim, Hwasoon, primary, M. Wruck, Lisa, primary, L. Stebbins, Amanda, primary, Muñoz, Daniel, primary, Kripalani, Sunil, primary, Effron, Mark B., primary, Gupta, Kamal, primary, Anderson, R. David, primary, Jain, Sandeep K., primary, Girotra, Saket, primary, Whittle, Jeff, primary, Benziger, Catherine P., primary, Farrehi, Peter, primary, Zhou, Li, primary, Polonsky, Tamar S, primary, Ahmad, Faraz S., primary, Roe, Matthew T., primary, Rothman, Russell L., primary, Harrington, Robert A., primary, Hernandez, Adrian F, primary, and Jones, W. Schuyler, primary
Published: 2023
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48. Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease and Diabetes Mellitus: A Subgroup Analysis of the ADAPTABLE Trial

Author: Narcisse, Dennis I., primary, Kim, Hwasoon, additional, Wruck, Lisa M., additional, Stebbins, Amanda L., additional, Muñoz, Daniel, additional, Kripalani, Sunil, additional, Effron, Mark B., additional, Gupta, Kamal, additional, Anderson, R. David, additional, Jain, Sandeep K., additional, Girotra, Saket, additional, Whittle, Jeff, additional, Benziger, Catherine P., additional, Farrehi, Peter, additional, Zhou, Li, additional, Polonsky, Tamar S., additional, Ahmad, Faraz S., additional, Roe, Matthew T., additional, Rothman, Russell L., additional, Harrington, Robert A., additional, Hernandez, Adrian F., additional, and Jones, W. Schuyler, additional
Published: 2023
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49. Association Between Cardiac Catheterization Laboratory Pre-Activation and Reperfusion Timing Metrics and Outcomes in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: A Report From the ACTION Registry

Author: Shavadia, Jay S., Roe, Matthew T., Chen, Anita Y., Lucas, Joseph, Fanaroff, Alexander C., Kochar, Ajar, Fordyce, Christopher B., Jollis, James G., Tamis-Holland, Jacqueline, Henry, Timothy D., Bagai, Akshay, Kontos, Michael C., Granger, Christopher B., and Wang, Tracy Y.
Published: 2018
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50. Using Digital Health Technology to Better Generate Evidence and Deliver Evidence-Based Care

Author: Sharma, Abhinav, Harrington, Robert A., McClellan, Mark B., Turakhia, Mintu P., Eapen, Zubin J., Steinhubl, Steven, Mault, James R., Majmudar, Maulik D., Roessig, Lothar, Chandross, Karen J., Green, Eric M., Patel, Bakul, Hamer, Andrew, Olgin, Jeffrey, Rumsfeld, John S., Roe, Matthew T., and Peterson, Eric D.
Published: 2018
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