Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes
Stephen D. Wiviott, M.D., Eugene Braunwald, M.D., Carolyn H. McCabe, B.S., Gilles Montalescot, M.D., Ph.D., Witold Ruzyllo, M.D., Shmuel Gottlieb, M.D., Franz-Joseph Neumann, M.D., Diego Ardissino, M.D., Stefano De Servi, M.D., Sabina A. Murphy, M.P.H., Jeffrey Riesmeyer, M.D., Govinda Weerakkody, Ph.D., C. Michael Gibson, M.D., Elliott M. Antman, M.D., for the TRITON–TIMI 38 Investigators
Background Dual-antiplatelet therapy with aspirin and a thienopyridineis a cornerstone of treatment to prevent thrombotic complicationsof acute coronary syndromes and percutaneous coronary intervention.
Methods To compare prasugrel, a new thienopyridine, with clopidogrel,we randomly assigned 13,608 patients with moderate-to-high-riskacute coronary syndromes with scheduled percutaneous coronaryintervention to receive prasugrel (a 60-mg loading dose anda 10-mg daily maintenance dose) or clopidogrel (a 300-mg loadingdose and a 75-mg daily maintenance dose), for 6 to 15 months.The primary efficacy end point was death from cardiovascularcauses, nonfatal myocardial infarction, or nonfatal stroke.The key safety end point was major bleeding.
Results The primary efficacy end point occurred in 12.1% ofpatients receiving clopidogrel and 9.9% of patients receivingprasugrel (hazard ratio for prasugrel vs. clopidogrel, 0.81;95% confidence interval [CI], 0.73 to 0.90; P<0.001). Wealso found significant reductions in the prasugrel group inthe rates of myocardial infarction (9.7% for clopidogrel vs.7.4% for prasugrel; P<0.001), urgent target-vessel revascularization(3.7% vs. 2.5%; P<0.001), and stent thrombosis (2.4% vs.1.1%; P<0.001). Major bleeding was observed in 2.4% of patientsreceiving prasugrel and in 1.8% of patients receiving clopidogrel(hazard ratio, 1.32; 95% CI, 1.03 to 1.68; P=0.03). Also greaterin the prasugrel group was the rate of life-threatening bleeding(1.4% vs. 0.9%; P=0.01), including nonfatal bleeding (1.1% vs.0.9%; hazard ratio, 1.25; P=0.23) and fatal bleeding (0.4% vs.0.1%; P=0.002).
Conclusions In patients with acute coronary syndromes with scheduledpercutaneous coronary intervention, prasugrel therapy was associatedwith significantly reduced rates of ischemic events, includingstent thrombosis, but with an increased risk of major bleeding,including fatal bleeding. Overall mortality did not differ significantlybetween treatment groups. (ClinicalTrials.gov number, NCT00097591
[ClinicalTrials.gov]
.)
Source Information
From Brigham and Women's Hospital and Harvard Medical School, Boston (S.D.W., E.B., C.H.M., S.A.M., C.M.G., E.M.A.); Institut de Cardiologie and INSERM Unit 856, Pitié–Salpêtrière University Hospital, Paris (G.M.); Instytut Kardiologii, Warsaw, Poland (W.R.); Bikur Cholim Hospital, Jerusalem, Israel (S.G.); Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany (F.-J.N.); Azienda Ospedaliero–Universitaria di Parma, Parma, Italy (D.A.); Azienda Ospedaliera Civile di Legano, Legano, Italy (S.D.S.); and Eli Lilly Research Laboratories, Indianapolis (J.R., G.W.). This article (10.1056/NEJMoa0706482) was published at www.nejm.org on November 4, 2007.
Address reprint requests to Dr. Antman at the Cardiovascular Division, Brigham and Women's Hospital, TIMI Study Group, 350 Longwood Ave., 1st Fl., Boston, MA 02115, or at eantman{at}rics.bwh.harvard.edu.
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