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Members of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial are listed in the Appendix and in the Supplementary Appendix , available with the full text of this article at www.nejm.org.
During the past 30 years, the use of percutaneous coronary intervention (PCI) has become common in the initial management strategy for patients with stable coronary artery disease in North America, even though treatment guidelines advocate an initial approach with intensive medical therapy, a reduction of risk factors, and lifestyle intervention (known as optimal medical therapy).1 ,2 In 2004, more than 1 million coronary stent procedures were performed in the United States,3 and recent registry data indicate that approximately 85% of all PCI procedures are undertaken electively in patients with stable coronary artery disease.4 PCI reduces the incidence of death and myocardial infarction in patients who present with acute coronary syndromes,5 -10 but similar benefit has not been shown in patients with stable coronary artery disease.11 -15 This issue has been studied in fewer than 3000 patients,16 many of whom were treated before the widespread use of intracoronary stents and current standards of medical management.17 -28
Although successful PCI of flow-limiting stenoses might be expected to reduce the rate of death, myocardial infarction, and hospitalization for acute coronary syndromes, previous studies have shown only that PCI decreases the frequency of angina and improves short-term exercise performance.11 ,12 ,15 Thus, the long-term prognostic effect of PCI on cardiovascular events in patients with stable coronary artery disease remains uncertain. Our study, the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, was designed to determine whether PCI coupled with optimal medical therapy reduces the risk of death and nonfatal myocardial infarction in patients with stable coronary artery disease, as compared with optimal medical therapy alone.
Methods
Study Design
The methods we used in the trial have been described previously.29 ,30 Sponsorship and oversight of the trial were provided by the Department of Veterans Affairs Cooperative Studies Program. Additional funding was provided by the Canadian Institutes of Health Research. Supplemental corporate support from several pharmaceutical companies included funding and in-kind support. All support from the pharmaceutical industry consisted of unrestricted research grants payable to the Department of Veterans Affairs.
The study protocol was approved...