Prasugrel versus clopidogrel for acute coronary syndromes without revascularization


Matthew T. Roe, Duke University Medical Center
Paul W. Armstrong, University of Alberta
Keith A.A. Fox, Edinburgh Medical School
Harvey D. White, Auckland City Hospital
Dorairaj Prabhakaran, Center for Chronic Disease Control
Shaun G. Goodman, Saint Michael's Hospital University of Toronto
Jan H. Cornel, Alkmaar Medical Centre
Deepak L. Bhatt, Brigham and Women's Hospital
Peter Clemmensen, Københavns Universitet
Felipe Martinez, Universidad Nacional de Cordoba
Diego Ardissino, Azienda Ospedaliero - Universitaria di Parma
Jose C. Nicolau, Universidade de Sao Paulo - USP
William E. Boden, Albany Medical College
Paul A. Gurbel, Sinai Center for Thrombosis Research
Witold Ruzyllo, Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynała Wyszynskiego
Anthony J. Dalby, Milpark Hospital
Darren K. McGuire, UT Southwestern Medical Center
Jose L. Leiva-Pons, Central Hospital Dr. Ignacio Morones Prieto
Alexander Parkhomenko, National Scientific Center M.D. Strazhesko Institute of Cardiology
Shmuel Gottlieb, Bikur Cholim Hospital
Gracita O. Topacio, De La Salle Medical and Health Sciences Institute
Christian Hamm, Kerckhoff-Klinik GmbH
Gregory Pavlides, Onassis Cardiac Surgery Centre
Assen R. Goudev, University Hospital Alexandrovska
Ali Oto, Hacettepe University, Faculty of Medicine
Chuen Den Tseng, National Taiwan University College of Medicine
Bela Merkely, Semmelweis Egyetem
Vladimir Gasparovic, University of Zagreb School of Medicine
Ramon Corbalan, Pontificia Universidad Católica de Chile
Mircea Cintezǎ, Universitatea de Medicina si Farmacie Carol Davila din Bucuresti
R. Craig McLendon, Duke University Medical Center
Kenneth J. Winters, Eli Lilly and Company

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New England Journal of Medicine


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.) Copyright © 2012 Massachusetts Medical Society.

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