on August 16, 2004
Circulation. 2004
Published online before print August 16, 2004, doi: 10.1161/01.CIR.0000140675.85342.1B
Published online before print August 16, 2004, doi: 10.1161/01.CIR.0000140675.85342.1B
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Submitted on June 10, 2003
From the Royal Infirmary of Edinburgh, Edinburgh, UK (K.A.A.F.); Division of Cardiology (S.R.M.) and Canadian Cardiovascular Collaboration Project Office (F.Z., S.Y.), Population Health Research Institute, McMaster University, Hamilton, Canada; Academic Medical Center, Amsterdam, Netherlands (R.P.); Baylor Hospital, Houston, Tex (N.L.); and Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, Minn (B.J.G.). * To whom correspondence should be addressed. E-mail: k.a.a.fox{at}ed.ac.uk.
Background--Antiplatelet therapy and antithrombin therapy have been demonstrated to reduce the risk of cardiac events in patients presenting with acute coronary syndrome, yet all effective therapies also increase the risk of bleeding. Methods and Results--In the Clopidogrel in Unstable angina to prevent Recurrent ischemic Events (CURE) trial, 12 562 patients were randomized to clopidogrel or placebo in addition to aspirin, and the primary outcome was cardiovascular (CV) death, myocardial infarction (MI), or stroke. The benefits were consistent among those undergoing percutaneous coronary intervention (PCI) [9.6% for clopidogrel, 13.2% for placebo; relative risk (RR), 0.72; 95% CI, 0.57 to 0.90], coronary artery bypass grafting (CABG) surgery (14.5% for clopidogrel 16.2% for placebo; RR, 0.89; 95% CI, 0.71 to 1.11), and medical therapy only (8.1% for clopidogrel, 10.0% for placebo; RR, 0.80; 95% CI, 0.69 to 0.92; test for interaction among strata, 0.53). For CABG during the initial hospitalization (530 for placebo, 485 for clopidogrel), the frequency of CV death, MI or stroke before CABG was 4.7% for placebo and 2.9% for clopidogrel (RR, 0.56; 95% CI, 0.29 to 1.08). For the entire study, there was a 1% excess of major bleeding but no significant excess of life-threatening bleeding. Among patients undergoing CABG, the rates of life-threatening bleeding were 5.6% for clopidogrel and 4.2% for placebo (RR, 1.30; 95% CI, 0.91 to 1.95; both nonsignificant). Conclusions--The benefits versus risks of early and long-term clopidogrel therapy (freedom from CV death, MI, stroke, or life-threatening bleeding) are similar in those undergoing revascularization (CABG or PCI) and in the study population as a whole. Overall, the benefits of starting clopidogrel on admission appear to outweigh the risks, even among those who proceed to CABG during the initial hospitalization.
Revised on May 26, 2004
Accepted on June 2, 2004
Benefits and Risks of the Combination of Clopidogrel and Aspirin in Patients Undergoing Surgical Revascularization for Non-ST-Elevation Acute Coronary Syndrome. The Clopidogrel in Unstable angina to prevent Recurrent ischemic Events (CURE) Trial
Keith A.A. Fox MBChB, FRCP, FESC*,
Key words: clopidogrel • coronary artery bypass • revascularization • coronary disease
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