Optimal Medical Therapy with or without PCI for Stable Coronary Disease

doi:10.1056/NEJMoa070829

Published at www.nejm.org March 26, 2007 (10.1056/NEJMoa070829)

Optimal Medical Therapy with or without PCI for Stable Coronary Disease

William E. Boden, M.D., Robert A. O'Rourke, M.D., Koon K. Teo, M.B., B.Ch., Ph.D., Pamela M. Hartigan, Ph.D., David J. Maron, M.D., William J. Kostuk, M.D., Merril Knudtson, M.D., Marcin Dada, M.D., Paul Casperson, Ph.D., Crystal L. Harris, Pharm.D., Bernard R. Chaitman, M.D., Leslee Shaw, Ph.D., Gilbert Gosselin, M.D., Shah Nawaz, M.D., Lawrence M. Title, M.D., Gerald Gau, M.D., Alvin S. Blaustein, M.D., David C. Booth, M.D., Eric R. Bates, M.D., John A. Spertus, M.D., M.P.H., Daniel S. Berman, M.D., G.B. John Mancini, M.D., William S. Weintraub, M.D., for the COURAGE Trial Research Group

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by Hochman, J. S.

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ABSTRACT

Background In patients with stable coronary artery disease,it remains unclear whether an initial management strategy ofpercutaneous coronary intervention (PCI) with intensive pharmacologictherapy and lifestyle intervention (optimal medical therapy)is superior to optimal medical therapy alone in reducing therisk of cardiovascular events.

Methods We conducted a randomized trial involving 2287 patientswho had objective evidence of myocardial ischemia and significantcoronary artery disease at 50 U.S. and Canadian centers. Between1999 and 2004, we assigned 1149 patients to undergo PCI withoptimal medical therapy (PCI group) and 1138 to receive optimalmedical therapy alone (medical-therapy group). The primary outcomewas death from any cause and nonfatal myocardial infarctionduring a follow-up period of 2.5 to 7.0 years (median, 4.6).

Results There were 211 primary events in the PCI group and 202events in the medical-therapy group. The 4.6-year cumulativeprimary-event rates were 19.0% in the PCI group and 18.5% inthe medical-therapy group (hazard ratio for the PCI group, 1.05;95% confidence interval [CI], 0.87 to 1.27; P=0.62). There wereno significant differences between the PCI group and the medical-therapygroup in the composite of death, myocardial infarction, andstroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to1.27; P=0.62); hospitalization for acute coronary syndrome (12.4%vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56);or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13;95% CI, 0.89 to 1.43; P=0.33).

Conclusions As an initial management strategy in patients withstable coronary artery disease, PCI did not reduce the riskof death, myocardial infarction, or other major cardiovascularevents when added to optimal medical therapy. (ClinicalTrials.govnumber, NCT00007657 [ClinicalTrials.gov] .)

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Affiliations for all authors are listed in the Appendix.

This article (10.1056/NEJMoa070829) was published at www.nejm.org on March 27, 2007.

Address reprint requests to Dr. Boden at the Division of Cardiology, Buffalo General Hospital, 100 High St., Buffalo, NY 14203, or at wboden{at}kaleidahealth.org.

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