COURAGE showed that in patients with stable coronary artery disease, an initial PCI strategy added to optimal medical therapy did not reduce death or nonfatal MI compared with optimal medical therapy alone. PCI improved angina earlier, but the symptom benefit narrowed over time.
Study design
- Multicenter, randomized trial
- N = 2,287
- Stable coronary artery disease with objective ischemia or significant angiographic CAD
- Randomized to PCI + optimal medical therapy vs optimal medical therapy alone
- Median follow-up 4.6 years
- Primary outcome: death from any cause or nonfatal MI
Population
Included
- Stable CAD
- Objective evidence of myocardial ischemia or ≥70% stenosis in at least one proximal epicardial coronary artery
- Patients suitable for PCI and intensive medical therapy
- Angina or ischemia-driven evaluation
Excluded / not the target population
- Acute coronary syndrome
- Markedly positive stress test requiring urgent revascularization
- Severe left main disease
- Severe LV dysfunction
- Refractory symptoms requiring immediate PCI
Stable CAD
N = 2,287
Median follow-up 4.6 yr
PCI + OMT
OMT alone
No ACS
Interventions
PCI + optimal medical therapy
- PCI of target lesions
- Mostly bare-metal stent era
- Aspirin and clopidogrel per protocol
- Aggressive risk-factor and antianginal therapy
Optimal medical therapy alone
- Antiplatelet therapy
- Statin and lipid lowering
- BP control
- Antianginal therapy
- Lifestyle and risk-factor modification
Primary outcome
- Primary outcome: death from any cause or nonfatal MI
- 19.0% with PCI + OMT vs 18.5% with OMT alone
- HR 1.05, 95% CI 0.87-1.27
- P = 0.62
- No reduction in death or MI with routine upfront PCI
PCI + OMT vs OMT alone
Death or nonfatal MI
25%
18.75%
12.5%
6.25%
0%
19.0% vs 18.5% | HR 1.05 | P = 0.62
Primary endpoint: death from any cause or nonfatal MI over median 4.6 years.
Secondary outcomes
| Outcome | PCI + OMT | OMT alone | Interpretation |
|---|---|---|---|
| Death or nonfatal MI | 19.0% | 18.5% | No significant difference |
| Death, MI, or stroke | 20.0% | 19.5% | No significant difference |
| Hospitalization for ACS | 12.4% | 11.8% | No significant difference |
| Angina relief | Greater early improvement | Improved with medical therapy | PCI improved symptoms earlier, but differences narrowed over time |
| Need for later revascularization | Lower | Higher | OMT-alone patients crossed over more often for symptoms or ischemia |
Safety
- No mortality or MI benefit from routine upfront PCI in stable CAD.
- PCI carried procedural risks and required antiplatelet therapy.
- Medical therapy alone was safe as an initial strategy in appropriately selected stable patients.
Practical point: COURAGE does not apply to ACS, left main disease, unstable symptoms, severe refractory angina, or patients who need revascularization for anatomy-driven prognostic benefit. It supports starting with optimal medical therapy in stable CAD when symptoms are manageable.
Interpretation
- Routine PCI did not reduce death or MI in stable CAD when added to optimal medical therapy.
- PCI is mainly a symptom-relief strategy in stable CAD, not automatically a mortality strategy.
- Aggressive medical therapy is the foundation: antiplatelet therapy, statins, BP control, antianginals, smoking cessation, exercise, and diabetes management.
- COURAGE changed the default approach from “fix the stenosis” to “treat the patient and reserve PCI for symptoms or high-risk anatomy.”
Citation: Boden WE, O'Rourke RA, Teo KK, et al. Optimal Medical Therapy with or without PCI for Stable Coronary Disease. New England Journal of Medicine. 2007;356:1503-1516.
NEJM