Do percutaneous coronary interventions improve outcomes when added to optimal medical therapy in patients with stable coronary disease?
Optimal medical therapy (treatment with a statin, an antiplatelet agent, an anti-anginal medication, and an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker) is as effective as percutaneous coronary interventions (PCIs) followed by optimal medical therapy for patients with chronic stable coronary artery disease (CAD). (LOE = 1b)
Boden WE, O'Rourke RA, Teo KK, et al, for the COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007;356:1503-1516. [PMID:17387127]
Randomized controlled trial (single-blinded)
The indications for PCI have broadened considerably since its introduction in the 1970s. However, guidelines still recommend optimal medical therapy as the first-line treatment for stable CAD, and studies have not shown a benefit of PCI in this population. Nevertheless, 85% of patients undergoing PCI each year have stable CAD as the indication. In this study, the largest to date, 2287 patients with stable angina were randomly assigned to receive intensive medical therapy or PCI followed by intensive medical therapy. All had at least one proximal vessel with 70% stenosis and evidence of myocardial ischemia (95% of patients) or at least one proximal vessel with 80% stenosis accompanied by classic angina without provocative testing. Patients with persistent class IV angina, heart failure, recent revascularization, anatomy not suitable for PCI, or a markedly positive stress test result were excluded. Intensive medical therapy consisted of aspirin or clopidogrel, metoprolol, amlodipine, and/or isosorbide mononitrate, and lisinopril or losartan. Simvastatin (Zocor) with or without ezetimibe (Zetia) was used to achieve a target low-density cholesterol level of less than 85 mg/dL (2.2 mmol/L). Exercise, extended-release niacin, and/or fibrates were used to achieve a high-density cholesterol level of greater than 40 mg/dL (1.03 mmol/L) and a triglyceride level of less than 150 mg/dL (1.67 mmol/L). Most patients did not receive a drug-eluting stent. The mean age of patients was 61 years, 85% were men, and 86% were white. Groups were balanced at the start of the study, analysis was by intention to treat, and patients were followed up for a mean of 4.6 years. Outcomes were assessed by researchers masked to treatment assignment. All but 46 of 1149 patients in the PCI group received the intervention; of those receiving a stent, 41% received more than one. Medical therapy was similarly intensive in both groups; for example, 70% in each group achieved their target LDL. Only 9% of patients were lost to follow-up in each group. The primary outcome was a composite of death or nonfatal myocardial infarction. There was no difference between groups (19% in each) and also no significant difference in the likelihood of all-cause mortality (8% in each group). Patients in the medical therapy group were more likely to require revascularization during the study (33% vs 21%; P < .001; number needed to treat to harm = 8). Of course, the total number of revascularizations was much higher in the PCI group if you include the initial PCs.
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