Background Despite current treatments, patients who have acutecoronary syndromes without ST-segment elevation have high ratesof major vascular events. We evaluated the efficacy and safetyof the antiplatelet agent clopidogrel when given with aspirinin such patients.
Methods We randomly assigned 12,562 patients who had presentedwithin 24 hours after the onset of symptoms to receive clopidogrel(300 mg immediately, followed by 75 mg once daily) (6259 patients)or placebo (6303 patients) in addition to aspirin for 3 to 12months.
Results The first primary outcome — a composite of deathfrom cardiovascular causes, nonfatal myocardial infarction,or stroke — occurred in 9.3 percent of the patients inthe clopidogrel group and 11.4 percent of the patients in theplacebo group (relative risk with clopidogrel as compared withplacebo, 0.80; 95 percent confidence interval, 0.72 to 0.90;P<0.001). The second primary outcome — the first primaryoutcome or refractory ischemia — occurred in 16.5 percentof the patients in the clopidogrel group and 18.8 percent ofthe patients in the placebo group (relative risk, 0.86, P<0.001).The percentages of patients with in-hospital refractory or severeischemia, heart failure, and revascularization procedures werealso significantly lower with clopidogrel. There were significantlymore patients with major bleeding in the clopidogrel group thanin the placebo group (3.7 percent vs. 2.7 percent; relativerisk, 1.38; P=0.001), but there were not significantly morepatients with episodes of life-threatening bleeding (2.1 percentvs. 1.8 percent, P=0.13) or hemorrhagic strokes.
Conclusions The antiplatelet agent clopidogrel has beneficialeffects in patients with acute coronary syndromes without ST-segmentelevation. However, the risk of major bleeding is increasedamong patients treated with clopidogrel.
Source Information
The Manuscript Writing Committee (Salim Yusuf, D.Phil., F.R.C.P.C., Feng Zhao, M.Sc., Shamir R. Mehta, M.D., F.R.C.P.C., Susan Chrolavicius, B.Sc., Gianni Tognoni, M.D., and Keith K. Fox, M.D., F.R.C.P.) assumes responsibility for the overall content of the manuscript.
Address reprint requests to Dr. Yusuf at the Canadian Cardiovascular Collaboration Project Office, Population Health Research Institute, McMaster University, Hamilton General Hospital, 237 Barton St. E., Hamilton, ON L8L 2X2, Canada, or at yusufs{at}mcmaster.ca.
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(2007). ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol
50: e1-e157
[Full Text]
Anderson, J. L., Adams, C. D., Antman, E. M., Bridges, C. R., Califf, R. M., Casey, D. E. Jr, Chavey, W. E. II, Fesmire, F. M., Hochman, J. S., Levin, T. N., Lincoff, A. M., Peterson, E. D., Theroux, P., Wenger, N. K., Wright, R. S., Smith, S. C. Jr, Jacobs, A. K., Adams, C. D., Anderson, J. L., Antman, E. M., Halperin, J. L., Hunt, S. A., Krumholz, H. M., Kushner, F. G., Lytle, B. W., Nishimura, R., Ornato, J. P., Page, R. L., Riegel, B.
(2007). ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction) Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol
50: 652-726
[Full Text]
Karnon, J., Brennan, A., Akehurst, R.
(2007). A Critique and Impact Analysis of Decision Modeling Assumptions. Med Decis Making
27: 491-499
[Abstract]
A correction has been published: N Engl J Med 2001;345(20):1506.
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