"Percutaneous Coronary Intervention for Stable Coronary Artery Disease".The New England Journal of Medicine. 2007. 356(15):1503-1516.
Links to original sources: Wiki Journal Post Full Journal Article
Contents 1Clinical Question 2Bottom Line 3Major Points 4Guidelines 5Design 6Population 6.1Inclusion Criteria 6.2Exclusion Criteria 7Interventions 8Outcomes 8.1Primary Outcomes 8.2Secondary Outcome 9Criticisms 10Funding 11Further Reading
In patients with stable coronary artery disease and myocardial ischemia, does management with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduce the risk of cardiovascular events compared to optimal medical therapy alone?
In patients with stable coronary artery disease, an initial management strategy of PCI combined with optimal medical therapy did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when compared to optimal medical therapy alone.
The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial was designed to assess the efficacy of PCI with optimal medical therapy versus optimal medical therapy alone in stable coronary artery disease. The trial showed that PCI did not reduce the rates of death, nonfatal myocardial infarction, or other major cardiovascular events. The trial supports the practice of initially using optimal medical therapy in patients with stable coronary artery disease.
Current guidelines recommend that optimal medical therapy should be the initial treatment approach for patients with stable coronary artery disease, reserving revascularization for symptom control or the development of an acute coronary syndrome.
- Multicenter, randomized, controlled trial - N=2,287 patients with stable coronary artery disease - PCI with optimal medical therapy (n=1,149) - Optimal medical therapy alone (n=1,138) - Enrollment: 1999 to 2004 - Median follow-up: 4.6 years
- Inclusion Criteria: Documented myocardial ischemia and significant coronary artery disease - Exclusion Criteria: Persistent severe angina, ejection fraction <30%, revascularization within previous 6 months, unsuitable coronary anatomy for PCI
- Patients randomized to either undergo PCI with optimal medical therapy or to receive optimal medical therapy alone
Primary Outcomes - The primary outcome was a composite of death from any cause and nonfatal myocardial infarction, which occurred in 19.0% of the PCI group and 18.5% of the medical-therapy group (hazard ratio 1.05; P=0.62)
Secondary Outcome - There were no significant differences between groups in a composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; P=0.56); or myocardial infarction (13.2% vs. 12.3%; P=0.33)
- The majority of patients were male (85%), limiting generalizability - Lack of ethnic diversity (14% nonwhite) - Predominant use of bare-metal stents; drug-eluting stents were available only in the final months of the study
- Sponsored by the U.S. Department of Veterans Affairs and additional funding from multiple pharmaceutical companies through unrestricted grants
- Full text available at The New England Journal of Medicine website