The Courage Trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial

Results – PCI does not improve mortality in medically optimized patients with stable coronary artery disease.

Over the last 30 years, in the USA and France, coronary angioplasty has become a standard treatment for stable angina, and this despite the recommendations of Learned Societies concerning the treatment of this condition. Today, 85 % of angioplasty procedures are performed on patients with stable angina.

The COURAGE trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation)trial was the first to provide evidence that in patients with stable coronary artery disease, the addition of PCI to optimal medical therapy does not provide any mortality benefit or improve cardiovascular outcomes. A subsequent report from the COURAGE investigators demonstrated that patients who received PCI were free of angina and had improvements in various quality of life parameters at three months after the intervention, though this difference was not sustained at 36 months.

Optimization of medical therapy alone without PCI is sufficient for initial treatment of patients with stable coronary artery disease. The addition of PCI to optimal medical therapy does not improve mortality or cardiovascular outcomes as evidenced by the COURAGE trial, and given its risks as an invasive procedure, should not be offered as initial treatment strategy for this patient population.

This trial, published in NEJM in 2007, enrolled 2,287 patients with stable coronary artery disease, objective evidence of myocardial ischemia, and significant disease in at least one major coronary artery. Patients were randomized to two groups: 1) optimal medical therapy alone, or 2) optimal medical therapy with PCI. All patients were optimized medically on an angiotensin-converting-enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB), antiplatelet therapy (acetylsalicylic acid or clopidogrel), as well as a combination of beta-blockers, calcium channel blockers and nitrates. All patients also received aggressive lipid optimizing therapy. The primary outcome studied was a composite of death from any cause and non-fatal myocardial infarction. The medium follow-up period was 4.6 years.

In patients undergoing PCI, 89% achieved clinical success. There was no significant difference in the primary outcome between the two groups. Furthermore, rates of hospitalization for ACS were not significantly different between the two groups. The need for subsequent revascularization procedures (PCI or coronary artery bypass graft) was, however, significantly higher in the medical therapy group as compared to the PCI group (32.6% vs. 21.1%).