COURAGE
Trial question
What is the role of PCI as an initial management strategy in patients with stable coronary artery disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
15.0% female
85.0% male
N = 2287
2287 patients (340 female, 1947 male).
Inclusion criteria: patients who had objective evidence of myocardial ischemia and significant coronary artery disease.
Key exclusion criteria: severe angina, a markedly positive stress test, refractory HF, cardiogenic shock, ejection fraction < 30%, or revascularization within 6 months.
Interventions
N=1149 PCI (plus optimal medical therapy).
N=1138 medical therapy (optimal medical therapy alone).
Primary outcome
Rate of death or nonfatal MI at 4.6 years follow-up
19%
18.5%
19.0 %
14.3 %
9.5 %
4.8 %
0.0 %
Percutaneous coronary
intervention
Medical
therapy
No significant
difference ↔
No significant difference in the rate of death or nonfatal MI at 4.6 years follow-up (19% vs. 18.5%; HR 1.05, 95% CI 0.87 to 1.27).
Secondary outcomes
No significant difference in death, MI and stroke (20% vs. 19.5%; HR 1.05, 95% CI 0.87 to 1.27).
No significant difference in hospitalization for acute coronary syndrome (12.4% vs. 11.8%; HR 1.07, 95% CI 0.84 to 1.37).
No significant difference in MI (13.2% vs. 12.3%; HR 1.13, 95% CI 0.89 to 1.43).
Conclusion
In patients who had objective evidence of myocardial ischemia and significant coronary artery disease, PCI was not superior to medical therapy with respect to the rate of death or nonfatal MI at 4.6 years follow-up.
Reference
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.
Open reference URL