Published online before print September 3, 2002, doi: 10.1161/01.CIR.0000029926.71825.E2
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(Circulation. 2002;106:1622.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
Benefit of Clopidogrel in Patients With Acute Coronary Syndromes Without ST-Segment Elevation in Various Risk Groups
From the Postgraduate Medical School, Grochowski Hospital Warsaw, Poland (A.B.); the Division of Cardiology and Population Health Research Institute, McMaster University, Hamilton, Canada (S.Y., S.R.M., F.Z., S.C.); the Royal Infirmary, Edinburgh, UK (K.A.A.F.); the Department of Cardiovascular Research Mario Negri Institute, Milan, Italy (G.T., M.G.F.); the Royal Melbourne Hospital, Australia (D.H.); and the Hungarian National Institute of Cardiology, Budapest, Hungary (M.K.).
Correspondence to Professor Salim Yusuf, McMaster Clinic, Hamilton General Hospital, 237 Barton Street East, Hamilton, Ontario, L8L 2X2, Canada. E-mail yusuf@ mcmaster.ca
Background— The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial demonstrated that clopidogrel, given early and continued long term, was superior to placebo in patients with non-ST–elevation acute coronary syndromes receiving aspirin. The purpose of the present analysis was to estimate the treatment effect Zof clopidogrel in patients who were stratified according to their risk of future cardiovascular events.
Methods and Results— Patients (n=12 562) who presented within 24 hours after the onset of symptoms were randomized to receive clopidogrel (300 mg followed by 75 mg daily) or placebo in addition to aspirin for 3 to 12 months. Treatment effect was analyzed in various risk groups according to the Thrombolysis in Myocardial Infarction (TIMI) risk score. The TIMI risk model was validated in the CURE population (C statistic, 0.634). The primary composite outcome of cardiovascular death, myocardial infarction, or stroke increased proportionally with increasing risk according to the TIMI risk score. The impact of clopidogrel versus placebo on the rate of the primary outcome was as follows: low-risk group (TIMI score 0 to 2), 4.1% versus 5.7% (relative risk [RR], 0.71; 95% confidence interval [CI], 0.52 to 0.97; P< 0.04), intermediate-risk group (TIMI score 3 to 4), 9.8% versus 11.4% (RR, 0.85; 95% CI, 0.74 to 0.98; P<0.03), and high-risk group (TIMI score 5 to 7), 15.9% versus 20.7% (RR, 0.73; 95% CI, 0.60 to 0.90; P<0.004). There was no evidence of statistical heterogeneity among the groups.
Conclusions— The benefit of clopidogrel demonstrated in the CURE trial is consistent in low-, intermediate-, and high-risk patients with acute coronary syndromes (as stratified by TIMI risk score), thus supporting its use in all patients with documented non–ST elevation acute coronary syndromes.
Key Words: angina • platelet aggregation inhibitors • drugs • risk factors
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Circulation 2002 106: 1588-1591.
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