Optimal medical therapy with or without PCI for stable coronary artery disease
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Optimal Medical Therapy With or Without PCI for Stable Coronary Artery Disease Boden WE, O’Rourke RA, Teo KK, et al.: Optimal medical therapy with or without PCI for stable coronary artery disease. N Engl J Med 2007, 356:1503–1516. Rating: Of importance. Introduction: A strategy of early percutaneous coronary intervention (PCI) as primary therapy for acute STelevation myocardial infarction and for high-risk patients with unstable angina and non–ST-elevation MI has been shown to improve important clinical outcomes. An initial management strategy of PCI for chronic stable angina pectoris has been shown to improve symptoms; however, it has not been demonstrated to improve cardiovascular events such as myocardial infarction and death. Despite this, PCI has become a frequently used initial management strategy for patients with stable coronary artery disease. Aims: The aim of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial was to determine whether an initial management strategy of PCI used in concert with optimal medical therapy would reduce the risk of death and MI, compared with optimal medical therapy alone. Methods: COURAGE was a randomized trial of 2287 subjects. For inclusion, subjects had to have the following: 1) either severe angina (Canadian Cardiovascular Society class III) and a coronary stenosis greater than 80% or at least one coronary stenosis greater than 70% and objective evidence of resting or inducible ischemia, and 2) at least one proximal or mid-coronary artery vessel appropriate for PCI. Major exclusion criteria included persistent class IV angina despite medical therapy, complicated post-MI course, left main coronary stenosis greater than 50%, low ejection fraction, very high-risk indicators on stress testing, shock, persistent congestive heart failure, recent CABG or PCI, and severe hypertension. Subjects were randomly allocated to undergo PCI or not as an initial strategy. All patients were to receive optimal medical therapy, including aspirin, anti-anginals (one or more of long-acting metoprolol, amlodipine, or nitrates), an inhibitor of the renin-angiotensin-aldosterone system, and aggressive lipid lowering with simvastatin or simvastatin and ezetemibe with a goal LDL of 60 to 85 mg/dL. The primary efficacy measure was the composite of all-cause mortality or nonfatal myocardial infarction.
Results: More than 35,000 patients were evaluated for the trial, with approximately 3000 meeting inclusion criteria and without exclusions, and 2287 were randomized with 1149 assigned to the PCI treatment group. PCI was attempted in 1077 subjects with at least one stent in 416 patients. Risk factors were well controlled, and a high percentage of patients received evidence-based medications. More than 30% of the initial medical therapy patients went on to have revascularization during followup. Median follow-up was 4.6 years, at which time 19.0% of the patients in the PCI group and 18.5% of the patients in the medical therapy group had death or nonfatal MI (haz
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