COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease

Western New York Veterans Affairs Healthcare Network and Buffalo General Hospital-SUNY, Buffalo, NY 14203, USA.
New England Journal of Medicine (Impact Factor: 55.87). 05/2007; 356(15):1503-16. DOI: 10.1056/NEJMoa070829
Source: PubMed


In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events.
We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6).
There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; 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).
As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. ( number, NCT00007657 [].).

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    • "However, the evaluation of functional relevance of CAD with noninvasive tests as gatekeeper to ICA remains mandatory. Indeed, the Clinical Outcome Utilizing Revascularization and Aggressive Drug Evaluation trial (COURAGE) [3] and the COURAGE trial nuclear substudy [4] have demonstrated that the event-free survival with coronary revascularization was greater than optimal medical therapy in patients with ≥10% ischemic myocardium at baseline and with a reduction of ischemic myocardium ≥5% after treatment. Stress myocardial perfusion imaging by cardiac magnetic resonance (stress-CMR) has emerged during the past decade as accurate technique for diagnosing and prognostic stratification of the patients with known or suspected CAD thanks to high spatial and temporal resolution, absence of ionizing radiation, and the multiparametric value including the assessment of cardiac anatomy, function, and viability [5]. "
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    • "An increasing number of hospitals have acquired the ability and qualifications to perform coronary angiography. Through clinical studies, it has been identified that multivessel lesions are common in stable angina and acute coronary syndrome (1,2), and are an independent predictor of CAD that affects the prognosis of patients (3). Controversy remains with regard to the treatment strategies for patients with multivessel complex coronary artery disease (MCCAD), particularly in recent years. "
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    • "The assessment of the haemodynamic clinical relevance of coronary arterial lesions seen on routine qualitative coronary angiography is important as evidence has emerged showing no long-term symptomatic or survival benefit for routine revascularisation procedures in patients with stable coronary disease [26]. Conversely, there is evidence for improved outcomes following revascularisation in subjects with known haemodynamically significant coronary artery lesions [3-6]. "
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