Prasugrel versus clopidogrel for acute coronary syndromes without revascularization

Matthew T. Roe, Paul W. Armstrong, Keith A A Fox, Harvey D. White, Dorairaj Prabhakaran, Shaun G. Goodman, Jan H. Cornel, Deepak L. Bhatt, Peter Clemmensen, Felipe Martinez, Diego Ardissino, Jose C. Nicolau, William E. Boden, Paul A. Gurbel, Witold Ruzyllo, Anthony J. Dalby, Darren K McGuire, Jose L. Leiva-Pons, Alexander Parkhomenko, Shmuel GottliebGracita O. Topacio, Christian Hamm, Gregory Pavlides, Assen R. Goudev, Ali Oto, Chuen Den Tseng, Bela Merkely, Vladimir Gasparovic, Ramon Corbalan, Mircea Cintezǎ, R. Craig McLendon, Kenneth J. Winters, Eileen B. Brown, Yuliya Lokhnygina, Philip E. Aylward, Kurt Huber, Judith S. Hochman, E. Magnus Ohman

Research output: Contribution to journalArticlepeer-review

727 Scopus citations

Abstract

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.)

Original languageEnglish (US)
Pages (from-to)1297-1309
Number of pages13
JournalNew England Journal of Medicine
Volume367
Issue number14
DOIs
StatePublished - Oct 4 2012

ASJC Scopus subject areas

  • General Medicine

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