Should COURAGE trial change our practice?

The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) Trial was a multi centre randomized trial involving 2287 patients who had objective evidence of myocardial ischaemia and stable coronary artery disease at 50 U.S. and Canadian centers. Study period was between 1999 and 2004. 1149 patients underwent 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).

The incidence of primary events in the PCI group was 211 compared with 202 in those prescribed medical treatment alone,(no statistical significance). The median cumulative primary event rates were 19.0% in the PCI group compared with 18.5% for medical treatment (hazard ratio (HR) for the PCI group 1.05, 95% CI 0.87 to 1.27; p = 0.62). No significant differences were seen between the two groups in the composite of death, myocardial infarction and stroke, PCI vs medical treatment, respectively (20% vs 19.5%, HR = 1.05, 95% CI 0.87 to 1.27; p = 0.62), hospitalisation for acute coronary syndrome (12.4% vs 11.8%, HR = 1.07, 95% CI 0.84 to 1.37; p = 0.56) or non-fatal myocardial infarction (13.2% vs 12.3%, HR = 1.13, 95% CI 0.89 to 1.43, p = 0.33).

The authors concluded that 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 treatment.


So should this study lead to a reduction of percutaneous coronary intervention in clinical practice? To decide this, a number of limitations of the study should be considered.

• Of the 35,539 patients screened more than 91% were excluded. How much can we generalize the findings?
• Most of the patients received only bare metal stents >97%. At least 50% of current practice involves drug eluting stents.
• 10% were lost to follow up in both arms. Was it due to mortality? we don't know.
• In the medical treatment arm 32.6% required revascularisation by the median 4.6 years of follow-up and in the PCI arm 21.1% underwent a further revascularisation procedure.
• At least 43% had very little symptoms. In practice most patients undergo PCI for difficult to control symptoms.

Reference List

1 Franklin BA. Lessons Learned From the COURAGE Trial: Generalizability, Limitations, and Implications. Prev Cardiol 2007;10(3):117-20.

2 King SB, III. The COURAGE trial: is there still a role for PCI in stable coronary artery disease? Nat Clin Pract Cardiovasc Med 2007 Aug;4(8):410-1.

3 Boden WE, O'Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007 Apr 12;356(15):1503-16.

4 Boden WE, O'Rourke RA, Teo KK, et al. The evolving pattern of symptomatic coronary artery disease in the United States and Canada: baseline characteristics of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial. Am J Cardiol 2007 Jan 15;99(2):208-12.