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201. Anti-Inflammatory Therapy With Canakinumab for the Prevention and Management of Diabetes.

Author

Everett, Brendan M., Donath, Marc Y., Pradhan, Aruna D., Thuren, Tom, Pais, Prem, Nicolau, Jose C., Glynn, Robert J., Libby, Peter, and Ridker, Paul M

Subjects
*DIABETES prevention, *ANTI-inflammatory agents, *TREATMENT of diabetes, *INTERLEUKIN-1, *INSULIN resistance, *THERAPEUTIC use of monoclonal antibodies, *TYPE 2 diabetes diagnosis, *BLOOD sugar, *COMPARATIVE studies, *DOSE-effect relationship in pharmacology, *RESEARCH methodology, *MEDICAL cooperation, *MONOCLONAL antibodies, *TYPE 2 diabetes, *PREDIABETIC state, *RESEARCH, *DISEASE management, *EVALUATION research, *BLIND experiment, *CHEMICAL inhibitors, *PHARMACODYNAMICS
Abstract

Background: Subclinical inflammation mediated in part by interleukin (IL)-1β participates in peripheral insulin resistance and impaired pancreatic insulin secretion.Objectives: The authors tested the hypothesis that the IL-1β inhibitor canakinumab reduces incident diabetes.Methods: The authors randomized 10,061 patients with prior myocardial infarction and high-sensitivity C-reactive protein (hsCRP) ≥2 mg/l to placebo or canakinumab at doses of 50 mg, 150 mg, or 300 mg subcutaneously once every 3 months. The authors tested the effects of canakinumab on major cardiovascular events in patients with and without diabetes at baseline, and evaluated as a pre-specified analysis whether canakinumab would reduce the risk of adjudicated cases of new-onset type 2 diabetes among those with protocol-defined pre-diabetes at trial entry. The authors also evaluated the effect of canakinumab on fasting plasma glucose and glycosylated hemoglobin (HbA1c) in patients with and without established diabetes.Results: Of the participants, 4,057 (40.3%) had baseline diabetes, 4,960 (49.3%) had pre-diabetes, and 1,044 (10.4%) had normal glucose levels. Among those without diabetes, increasing tertiles of hsCRP at baseline associated with an increased risk of developing diabetes during the median follow-up period of 3.7 years (incidence rates 3.2, 4.1, and 4.4 per 100 person-years; p = 0.003). Canakinumab 150 mg as compared with placebo had similar magnitude effects on major cardiovascular event rates among those with diabetes (hazard ratio [HR]: 0.85; 95% confidence interval [CI]: 0.70 to 1.03), pre-diabetes (HR: 0.86; 95% CI: 0.70 to 1.06), and normoglycemia (HR: 0.81; 95% CI: 0.49 to 1.35). Despite large reductions in hsCRP and IL-6, canakinumab did not reduce the incidence of new-onset diabetes, with rates per 100 person-years in the placebo, 50 mg, 150 mg, and 300 mg canakinumab groups of 4.2, 4.2, 4.4, and 4.1, respectively (log-rank p = 0.84). The HR comparing all canakinumab doses to placebo was 1.02 (95% CI: 0.87 to 1.19; p = 0.82). Canakinumab reduced HbA1c during the first 6 to 9 months of treatment, but no consistent long-term benefits on HbA1c or fasting plasma glucose were observed.Conclusions: Although IL-1β inhibition with canakinumab had similar effects on major cardiovascular events among those with and without diabetes, treatment over a median period of 3.7 years did not reduce incident diabetes. (Canakinumab Anti-inflammatory Thrombosis Outcomes Study [CANTOS]; NCT01327846). [ABSTRACT FROM AUTHOR]

Published
2018
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202. Sudden Cardiac Death in Patients With Ischemic Heart Failure Undergoing Coronary Artery Bypass Grafting: Results From the STICH Randomized Clinical Trial (Surgical Treatment for Ischemic Heart Failure).

Author

Rao, Meena P., Al-Khatib, Sana M., Pokorney, Sean D., She, Lilin, Romanov, Alexander, Nicolau, Jose C., Lee, Kerry L., Carson, Peter, Selzman, Craig H., Stepinska, Janina, Cleland, John G. F., Tungsubutra, Wiwun, Desvigne-Nickens, Patrice M., Sueta, Carla A., Siepe, Matthias, Lang, Irene, Feldman, Arthur M., Yii, Michael, Rouleau, Jean L., and Velazquez, Eric J.

Subjects
*CARDIAC arrest, *SUDDEN death, *CORONARY artery bypass risk factors, *CORONARY disease, *CLINICAL trials, *REVASCULARIZATION (Surgery), *ATRIAL fibrillation prevention, *ANTILIPEMIC agents, *ATRIAL fibrillation, *CELL receptors, *COMPARATIVE studies, *CORONARY artery bypass, *LEFT heart ventricle, *HEART physiology, *HEART failure, *LONGITUDINAL method, *RESEARCH methodology, *MEDICAL cooperation, *MULTIVARIATE analysis, *PEPTIDE hormones, *POSTOPERATIVE period, *RESEARCH, *RESEARCH funding, *EVALUATION research, *RANDOMIZED controlled trials, *DISEASE incidence, *PROPORTIONAL hazards models, *STROKE volume (Cardiac output)
Abstract

Background: The risk of sudden cardiac death (SCD) in patients with heart failure after coronary artery bypass graft surgery (CABG) has not been examined in a contemporary clinical trial of surgical revascularization. This analysis describes the incidence, timing, and clinical predictors of SCD after CABG.Methods: Patients enrolled in the STICH trial (Surgical Treatment of Ischemic Heart Failure) who underwent CABG with or without surgical ventricular reconstruction were included. We excluded patients with prior implantable cardioverter-defibrillator and those randomized only to medical therapy. The primary outcome was SCD as adjudicated by a blinded committee. A Cox model was used to examine and identify predictors of SCD. The Fine and Gray method was used to estimate the incidence of SCD accounting for the competing risk of other deaths.Results: Over a median follow-up of 46 months, 113 of 1411 patients who received CABG without (n = 934) or with (n = 477) surgical ventricular reconstruction had SCD; 311 died of other causes. The mean left ventricular ejection fraction at enrollment was 28±9%. The 5-year cumulative incidence of SCD was 8.5%. Patients who had SCD and those who did not die were younger and had fewer comorbid conditions than did those who died of causes other than SCD. In the first 30 days after CABG, SCD (n=5) accounted for 7% of all deaths. The numerically greatest monthly rate of SCD was in the 31- to 90-day time period. In a multivariable analysis including baseline demographics, risk factors, coronary anatomy, and left ventricular function, end-systolic volume index and B-type natriuretic peptide were most strongly associated with SCD.Conclusions: The monthly risk of SCD shortly after CABG among patients with a low left ventricular ejection fraction is highest between the first and third months, suggesting that risk stratification for SCD should occur early in the postoperative period, particularly in patients with increased preoperative end-systolic volume index or B-type natriuretic peptide.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT0002359. [ABSTRACT FROM AUTHOR]

Published
2017
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204. Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction

Author

Javed Butler, Stefan D Anker, Lars H Lund, Andrew J S Coats, Gerasimos Filippatos, Tariq Jamal Siddiqi, Tim Friede, Vincent Fabien, Mikhail Kosiborod, Marco Metra, Ileana L Piña, Fausto Pinto, Patrick Rossignol, Peter van der Meer, Cecilia Bahit, Jan Belohlavek, Michael Böhm, Jasper J Brugts, John G F Cleland, Justin Ezekowitz, Antoni Bayes-Genis, Israel Gotsman, Assen Goudev, Irakli Khintibidze, Joann Lindenfeld, Robert J Mentz, Bela Merkely, Eliodoro Castro Montes, Wilfried Mullens, Jose C Nicolau, Aleksandr Parkhomenko, Piotr Ponikowski, Petar M Seferovic, Michele Senni, Evgeny Shlyakhto, Alain Cohen-Solal, Peter Szecsödy, Klaus Jensen, Fabio Dorigotti, Matthew R Weir, Bertram Pitt, Cardiology, Pinto, Fausto J./0000-0002-8034-4529, Lund, Lars H/0000-0003-1411-4482, Metra, Marco/0000-0001-6691-8568, Friede, Tim/0000-0001-5347-7441, Butler, Javed, Anker, Stefan D., Lund, Lars H., Coats, Andrew J. S., Filippatos, Gerasimos, Siddiqi, Tariq Jamal, Friede, Tim, Fabien, Vincent, Kosiborod, Mikhail, Metra, Marco, Pina, Ileana L., Pinto, Fausto, Rossignol, Patrick, van der Meer, Peter, Bahit, Cecilia, Belohlavek, Jan, Boehm, Michael, Brugts, Jasper J., Cleland, John G. F., Ezekowitz, Justin, Bayes-Genis, Antoni, Gotsman, Israel, Goudev, Assen, Khintibidze, Irakli, Lindenfeld, Joann, Mentz, Robert J., Merkely, Bela, Montes, Eliodoro Castro, MULLENS, Wilfried, Nicolau, Jose C., Parkhomenko, Aleksandr, Ponikowski, Piotr, Seferovic, Petar M., Senni, Michele, Shlyakhto, Evgeny, Cohen-Solal, Alain, Szecsoedy, Peter, Jensen, Klaus, Dorigotti, Fabio, Weir, Matthew R., Pitt, Bertram, Cardiovascular Centre (CVC), and Restoring Organ Function by Means of Regenerative Medicine (REGENERATE)

Subjects
Heart Failure, RANDOMIZED ALDACTONE EVALUATION, renin-angiotensin-aldosterone system inhibitors (RAASi), Stroke Volume, KIDNEY-DISEASE, Heart failure with reduced ejection fraction, Patiromer, SPIRONOLACTONE, THERAPY, Hyperkalemia, Potassium-binding polymer, Renin-Angiotensin System, Potassium, Renin-angiotensin-aldosterone system inhibitor (RAASi), Humans, Cardiology and Cardiovascular Medicine, INHIBITORS, Mineralocorticoid Receptor Antagonists
Abstract

Aims To investigate the impact of patiromer on the serum potassium level and its ability to enable specified target doses of renin–angiotensin–aldosterone system inhibitor (RAASi) use in patients with heart failure and reduced ejection fraction (HFrEF). Methods and results A total of 1642 patients with HFrEF and current or a history of RAASi-related hyperkalemia were screened and 1195 were enrolled in the run-in phase with patiromer and optimization of the RAASi therapy [≥50% recommended dose of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, and 50 mg of mineralocorticoid receptor antagonist (MRA) spironolactone or eplerenone]. Specified target doses of the RAASi therapy were achieved in 878 (84.6%) patients; 439 were randomized to patiromer and 439 to placebo. All patients, physicians, and outcome assessors were blinded to treatment assignment. The primary endpoint was between-group difference in the adjusted mean change in serum potassium. Five hierarchical secondary endpoints were assessed. At the end of treatment, the median (interquartile range) duration of follow-up was 27 (13–43) weeks, the adjusted mean change in potassium was +0.03 mmol/l in the patiromer group and +0.13 mmol/l in the placebo group [difference in the adjusted mean change between patiromer and placebo: −0.10 mmol/l (95% confidence interval, CI −0.13, 0.07); P < 0.001]. Risk of hyperkalemia >5.5 mmol/l [hazard ratio (HR) 0.63; 95% CI 0.45, 0.87; P = 0.006), reduction of MRA dose (HR 0.62; 95% CI 0.45, 0.87; P = 0.006), and total adjusted hyperkalemia events/100 person-years (77.7 vs. 118.2; HR 0.66; 95% CI 0.53, 0.81; P < 0.001) were lower with patiromer. Hyperkalemia-related morbidity-adjusted events (win ratio 1.53, P < 0.001) and total RAASi use score (win ratio 1.25, P = 0.048) favored the patiromer arm. Adverse events were similar between groups. Conclusion Concurrent use of patiromer and high-dose MRAs reduces the risk of recurrent hyperkalemia (ClinicalTrials.gov: NCT03888066).

Published
2022

205. Diagnostic Ultrasound Impulses Improve Microvascular Flow in Patients With STEMI Receiving Intravenous Microbubbles.

Author

Jr.Mathias, Wilson, Tsutsui, Jeane M., Tavares, Bruno G., Xie, Feng, Aguiar, Miguel O.D., Garcia, Diego R., Jr.Oliveira, Mucio T., Soeiro, Alexandre, Nicolau, Jose C., NetoLemos, Pedro A., Rochitte, Carlos E., Ramires, José A.F., FilhoKalil, Roberto, Porter, Thomas R., Mathias, Wilson Jr, Oliveira, Mucio T Jr, Lemos, Pedro A Neto, and Kalil, Roberto Filho

Subjects
*MYOCARDIAL infarction, *DIAGNOSTIC ultrasonic imaging, *MICROCIRCULATION, *MICROBUBBLE diagnosis, *CLINICAL trials, *PERCUTANEOUS coronary intervention, *PATIENTS, *CORONARY heart disease treatment, *THROMBOSIS, *CARDIOVASCULAR system, *COMPARATIVE studies, *CORONARY artery stenosis, *CORONARY circulation, *CORONARY disease, *RESEARCH methodology, *MEDICAL care, *MEDICAL cooperation, *RESEARCH, *ULTRASONIC therapy, *EVALUATION research, *EQUIPMENT & supplies, *RANDOMIZED controlled trials, *STROKE volume (Cardiac output), *CORONARY angiography, *THERAPEUTICS
Abstract

Background: Pre-clinical trials have demonstrated that, during intravenous microbubble infusion, high mechanical index (HMI) impulses from a diagnostic ultrasound (DUS) transducer might restore epicardial and microvascular flow in acute ST-segment elevation myocardial infarction (STEMI).Objectives: The purpose of this study was to test the safety and efficacy of this adjunctive approach in humans.Methods: From May 2014 through September 2015, patients arriving with their first STEMI were randomized to either DUS intermittent HMI impulses (n = 20) just prior to emergent percutaneous coronary intervention (PCI) and for an additional 30 min post-PCI (HMI + PCI), or low mechanical index (LMI) imaging only (n = 10) for perfusion assessments before and after PCI (LMI + PCI). All studies were conducted during an intravenous perflutren lipid microsphere infusion. A control reference group (n = 70) arrived outside of the time window of ultrasound availability and received emergent PCI alone (PCI only). Initial epicardial recanalization rates prior to emergent PCI and improvements in microvascular flow were compared between ultrasound-treated groups.Results: Median door-to-dilation times were 82 ± 26 min in the LMI + PCI group, 72 ± 15 min in the HMI + PCI group, and 103 ± 42 min in the PCI-only group (p = NS). Angiographic recanalization prior to PCI was seen in 12 of 20 HMI + PCI patients (60%) compared with 10% of LMI + PCI and 23% of PCI-only patients (p = 0.002). There were no differences in microvascular obstructed segments prior to treatment, but there were significantly smaller proportions of obstructed segments in the HMI + PCI group at 1 month (p = 0.001) and significant improvements in left ventricular ejection fraction (p < 0.005).Conclusions: HMI impulses from a diagnostic transducer, combined with a commercial microbubble infusion, can prevent microvascular obstruction and improve functional outcome when added to the contemporary PCI management of acute STEMI. (Therapeutic Use of Ultrasound in Acute Coronary Artery Disease; NCT02410330). [ABSTRACT FROM AUTHOR]

Published
2016
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206. Saxagliptin and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Moderate or Severe Renal Impairment: Observations From the SAVOR-TIMI 53 Trial.

Author

Udell, Jacob A., Bhatt, Deepak L., Braunwald, Eugene, Cavender, Matthew A., Mosenzon, Ofri, Steg, Ph. Gabriel, Davidson, Jaime A., Nicolau, Jose C., Corbalan, Ramon, Hirshberg, Boaz, Frederich, Robert, KyungAh Im, Umez-Eronini, Amarachi A., He, Ping, McGuire, Darren K., Leiter, Lawrence A., Raz, Itamar, and Scirica, Benjamin M.

Subjects
*HYPOGLYCEMIC agents, *HYPOGLYCEMIA, *TYPE 2 diabetes, *DIABETES, *KIDNEY diseases
Abstract

OBJECTIVE The glycemic management of patients with type 2 diabetes mellitus (T2DM) and renal impairment is challenging, with fewtreatment options.We investigated the effect of saxagliptin in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with DiabetesMellitus (SAVOR)-Thrombolysis inMyocardial Infarction (TIMI) 53 trial according to baseline renal function. RESEARCH DESIGN AND METHODS Patients with T2DM at risk for cardiovascular events were strati ed as having normal or mildly impaired renal function (estimated glomerular filtration rate [eGFR] >50 mL/min/1.73 m² ; n = 13,916), moderate renal impairment (eGFR 30-50 mL/min/1.73 m² ; n = 2,240), or severe renal impairment (eGFR <30 mL/min/1.73 m² ; n =336) and randomized to receive saxagliptin or placebo. The primary end point was cardiovascular death, myocardial infarction, or ischemic stroke. RESULTS After a median duration of 2 years, saxagliptin neither increased nor decreased the risk of the primary and secondary composite end points compared with placebo, irrespective of renal function (all P for interactions ≥0.19). Overall, the risk of hospitalization for heart failure among the three eGFR groups of patients was 2.2% (referent), 7.4% (adjusted hazard ratio [HR] 2.38 [95% CI 1.95-2.91], P < 0.001), and 13.0% (adjusted HR 4.59 [95% CI 3.28-6.28], P < 0.001), respectively. The relative risk of hospitalization for heart failure with saxagliptin was similar (P for interaction = 0.43) in patients with eGFR >50mL/min/1.73m² (HR 1.23 [95% CI 0.99-1.55]), eGFR 30-50 mL/min/1.73 m² (HR 1.46 [95% CI 1.07-2.00]), and in patients with eGFR <30 (HR 0.94 [95% CI 0.52-1.71]). Patients with renal impairment achieved reductions in microalbuminuria with saxagliptin (P =0.041) that were similar to those of the overall trial population. CONCLUSIONS Saxagliptin did not affect the risk of ischemic cardiovascular events, increased the risk of heart failure hospitalization, and reduced progressive albuminuria, irrespective of baseline renal function. [ABSTRACT FROM AUTHOR]

Published
2015
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207. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization

Author

L. Wang, T. Stys, William E. Boden, R. H. Urbano, D. M. Olinic, Karen S. Pieper, A. Kuijper, E. Soh, J. Nicolau, Jadwiga Nessler, William J. Rogers, Ernesto Rivera, R. Braam, H. Kadr, J. Csikasz, B. Boichev, Prafulla Kerkar, I. Kraiz, R. Babu, Ali Aydinlar, D. Safley, O. Nguyen-Khac, P. Chua, W. Buchanan, C. A. Morales, A. Abyankar, A. Srinivas, S. Genth-Zotz, J. Rocha Faria Neto, D. Drenning, L. Moretti, S. Varma, D. Roth, C. Matei, Jane E. Onken, H. Tumbev, P. Keeling, Xian Li, N. Ciglenecki, Shahyar M. Gharacholou, P. P. Goh, D. Sporn, M. Chang, Marcin Gruchała, R. Foreman, Bogdan Minescu, S. Nawaz, N. Alexeeva, Y. Shalev, C. Fastabend, L. van Zyl, J. F. Certic, J. Longo, J. Wang, K. Dave, Olivier Morel, F. Maatouk, Y. El Rakshy, J. Giacomini, P. Lazov, R. Marino, Dimitar Raev, M. Y. Chan, L. Z. Dextre, Y. Hao, P. Sepulveda, K. Ramshev, C. Bayron, Ameer Kabour, Alon Marmor, Luciano Moreira Baracioli, H. Marais, Rajendra H. Mehta, R. Breedveld, A. Ben Khalfallah, Kurtulus Ozdemir, I. Westendorp, J. A. Quion, Daniel J. George, D. F. Garcia, J.-P Bassand, G. Szalai, Huw Griffiths, O. Ushakov, M. Tzekova, E. Suprun, A. Mowafy, N. El Mansour, Gail V.W. Johnson, Tereshchenko Sn, W. T. Lai, Petr Widimsky, Hany Ragy, V. R. Castillo, M. Padour, Gilles Montalescot, Louie Tirador, Deepak L. Bhatt, M. Marrinan, S. Promisloff, A. Nambiar, Reginald G.E.J. Groutars, S. R. Lee, J. Cabrera, S. Zhang, András Jánosi, K. Wita, R. Sciborski, Annabelle Rodriguez, P. Sedlon, Jaroslaw D. Kasprzak, A. Faynyk, A. Romero Acuña, M. C. Ramirez, Rakesh Gupta, R. Saligrama, Jacek Gniot, Y. Ke, John H. Alexander, X. Liu, E. Baranov, R. Grzywna, Mukul Sharma, A. Linka, Jarosław Wójcik, Haroon Rashid, M. S. Sanchez, M. Gadkari, B. Rao, James S. Zebrack, Paul W. Armstrong, Francois Schiele, Gracita O. Topacio, Peter J. Casterella, A. Belhassane, P. Golino, F. Plat, P. Roberts-Thomson, K. S. Kim, Stephen D. Wiviott, Mathew T. Roe, Y. D. Chen, I. A. Khan, S. Thanvi, S. Isserman, G. Falck, R. M. Coching, S. C. Stamate, M. Ogorek, K. Danisa, Poul Anders Hansen, M. Medvegy, Amos Katz, R. K. Seerangachar, B. Farah, V. Kale, B. Kusnick, Maurice Pye, M. Mosseri, M. Vatutin, D. Weinstein, Norma Keller, A. Mihov, Ewa Mirek-Bryniarska, N. Adjei, S. Sethi, A. Irimpen, M. Broeders, T. Huynh, K. Niezgoda, P. Samardzic, D. Ziperman, Stuart J. Pocock, T. Arad, J. Lewczuk, M. Amuchastegui, R. Moscoso, B. Dimov, W. A. Ahmad, E. Dalli, P. Laothavorn, S. Shaikh, Helmut U. Klein, J. Menon, H. Colombo, L. Fattore, G. Zarrella, Dorairaj Prabhakaran, N. Viboolkitvarakul, Judith D. Goldberg, Neetika Garg, Y. Hasin, F. Rossi Dos Santos, S. J. Vigo, L. Horbach, O. Prokhorov, H. Moellmann, T. R. Vera, C. E. Botta, Domitilla Russo, M. Rossovskaya, David C. Henderson, Rebecca B. Costello, V. Shcherbak, C. J.P.J. Werter, W. Kus, I. Dobre, P. Marechal, T. Nair, H. Nielsen, J. Waites, J. B. Moraes Junior, T. Römer, J. Senior, P. Ionescu, S. Kalashetti, R. N. Ortega, Gail E. Hafley, G. A. Dan, Apur R. Kamdar, Ruth Ann Greenfield, David F. Kong, J. Bergallo, O. Barnum, Antonis S. Manolis, Sumeet Subherwal, S. Schaefer, A. Figueredo, Habib Gamra, S. Bandyopadhyay, V. Miloradovic, Imran Arif, Peter R. Carroll, M. Demirtas, S. Guidera, G. Rogelio, Naseem Jaffrani, N. Mulvihill, Marvin J. Slepian, Darren K. McGuire, Rohit Kalra, Luís A. Providência, F. Van de Werf, Andras Vertes, J. Xu, C. F. Gamio, R. G. Xuereb, R. F. Ramos, E. Kis, N. Bustros, M. De Luca, S. Zhurba, T. Connelly, S. Singhi, F. Gredler, Serdar Kucukoglu, Francesco Fedele, C. Chavez, Christoph Kadel, Antônio Carlos Sobral Sousa, S. Srimahachota, Igor Kaidashev, J. H. Garcia, I. Teodorescu, Birute Petrauskiene, O. Kracoff, Liwa T. Younis, Alain Bouchard, P. Osmancik, Y. Sun, C. Hammett, S. Sabri, William Wallace, Mehmet Yazici, L. Ermoshkina, Harish Chandna, G. Ramos-Lopez, M. Bronisz, Sergio Luiz Zimmermann, Giuseppe Ambrosio, V. Hergeldjieva, César A. Jardim, A. Rifai, H. Lui, A. Lee, J. Scholz Issa, A. Blenkhorn, P. Micale, V. Barbarich, C. Maccallum, Peter J. Grant, G. Topacio, N. Budassi, J. Yan, Keith A.A. Fox, Y. Xia, Jan H. Cornel, A. Rafael, Paul Hermany, S. Potthoff, Mohsin A.F. Khan, Pierre Coste, Neal Ready, N. T. Duda, M. Reyes, A. Chandran, I. G. Gordeev, Anne W. Beaven, B. J.B. Hamer, C. Treasure, Pravin Manga, M. R. Babarskiene, T. Devedzhiev, Alberto Menozzi, L. Lenarz, N. Llerena, Thomas F. Lüscher, Giovânio Vieira da Silva, Y. Malynovsky, L. Ramanathan, M. Belicova, M. O. Ibarra, D. Chew, R. Castillo, M. Kesselbrenner, A. H. Li, E. Baldjiev, M. El-Harari, S. H. Hur, S. Chiaramida, C. E. Chiang, Viliam Fridrich, L. R. Cartasegna, A. Yagensky, Steven E. Hearne, Gregory Pavlides, Witold Rużyłło, Y. Chandrashekhar, S. Welka, H. Petijean, Jose L. Leiva-Pons, Shaul Atar, Andrzej Lubiński, S. Zhao, János Tomcsányi, Narinder Singh, D. Banker, T. Boyek, H. Ebinc, N. Calambur, A. Mouhaffel, M. Creteanu, H. Huang, J. O. Jeong, E. Goudreau, D. Alexopoulos, E. Duronto, S. Car, O. Bashkirtsev, J. Mandak, V. Papademetriou, David O. Williams, Oscar Pereira Dutra, R. Baman, T. J. Hong, J. O. Ibañez, D. L. Gomez, R. K. Jain, R. Jozwa, L. Di Lorenzo, Matthew Wilson, Christian W. Hamm, A. Buakhamsri, Nikitas Moschos, Ashok Kumar, A. Kadiiski, C. Y. Lee, M. Opazo, J. Tang, E. Ferrari, P. Colon-Hernandez, Jean-Pierre Déry, B. Goloborodko, L. Gimple, Diego Ardissino, M. Bergovec, S. Thew, Dariusz Dudek, K. Tang, P. A.G. Zwart, A. Deshpande, S. Sathe, Yves Cottin, V. Pai, O. Koval, J. Lesnik, Pavan S. Reddy, A. Espinoza, Rungroj Krittayaphong, Carisi Anne Polanczyk, E. Kukuy, L. Tejada, J. Nobel, Renato D. Lopes, J. Bagatin, A. Manolova, E. Boudriot, A. Godoy, N. Perepech, Christopher D. Olympios, A. E. Guimarães, James Harris, Aref Rahman, D. Foley, H. J. Kruik, J. Bruguera I Cortada, I. Fotiadis, A. Bharani, Petar Otasevic, Eileen Brown, N. Gratsiansky, J. E. Poulard, Vladimir Gašparović, Habib Haouala, A. de Belder, J. Schmedtje, Lilia Nigro Maia, J. Cobos, Werner Benzer, E. Korban, A. U. Quraishi, X. Hong, A. Bazzi, P. Kotha, L. Gubolino, H. Ingersoll, Debra Marshall, Udo Sechtem, Sandipan Dutta, G. Frago, Anthony Mathur, Shaun G. Goodman, William Bachinsky, A. Hamer, Jaime Gomez, Patrizio Lancellotti, Vance Wilson, L. White, P.P. Mohanan, Aleksandar Knezevic, Sorin J. Brener, Susanna R. Stevens, H. Luquez, S. K. Lee, P. E. Leaes, P. Benjarge, T. Tu, Z. Coufal, N. Koliopoulos, Mahmut Şahin, X. Huang, S. Boldueva, J. De Souza, N. Chidambaram, S. Zolyomi, K. G. Shyu, H. Montecinos, A. Piombo, Wladmir Faustino Saporito, R. L. Kulkarni, I. Szakal, G. Arminio, M. Elbaz, Samir Pancholy, Jang Ho Bae, Giuseppe Musumeci, S. B. Zouari, A. Chois, D. Wojciechowski, A. Bakbak, E. Bozkurt, Kenneth J. Winters, R. Raugaliene, D. Sarkar, J. M. Alegret, Hubertus Heuer, E. Bobescu, E. Roncallo, R. Carlsson, R. Craig McLendon, L K Newby, K. Zrazhevskiy, João Pedro Ferreira, A. Haidar, D. 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Subjects
Male, Prasugrel, Myocardial Infarction, Kaplan-Meier Estimate, Piperazines, Purinergic P2 Receptor Antagonists, Myocardial infarction, education.field_of_study, Cardiovascular diseases [NCEBP 14], Acute Coronary Syndrome, Aged, Angina, Unstable, Aspirin, Cardiovascular Diseases, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Middle Aged, Platelet Aggregation Inhibitors, Prasugrel Hydrochloride, Stroke, Thiophenes, Ticlopidine, Medicine (all), Hazard ratio, Clopidogrel, Acute Coronary Syndromes, General Medicine, Angina, Combination, Cardiology, medicine.drug, medicine.medical_specialty, Acute coronary syndrome, Population, Unstable, Drug Therapy, General & Internal Medicine, Internal medicine, medicine, cardiovascular diseases, education, Acute coronary syndromes, Revascularisation, Unstable angina, business.industry, medicine.disease, REVASCULARIZAÇÃO MIOCÁRDICA, business
Abstract

Item does not contain fulltext BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).

Published
2012

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