article73

COURAGE

"Percutaneous Coronary Intervention for Stable Coronary Artery Disease".The New England Journal of Medicine. 2007. 356(15):1503-1516.PubMed•Full text•PDF

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

Clinical Question

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?

Bottom Line

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.

Major Points

Guidelines

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.

Design

- 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

Population

- 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

Interventions

- Patients randomized to either undergo PCI with optimal medical therapy or to receive optimal medical therapy alone

Outcomes

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)

Criticisms

- 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

Funding

- Sponsored by the U.S. Department of Veterans Affairs and additional funding from multiple pharmaceutical companies through unrestricted grants