Optimal medical therapy with or without PCI for stable coronary disease.
Level 2 - randomized trial
Individual multicenter randomized controlled trial
PubMed 17387127 · doi:10.1056/NEJMoa070829
What was done
Between 1999 and 2004, 2287 patients with objective evidence of myocardial ischemia and significant coronary artery disease across 50 centers in the United States and Canada were randomized to receive either percutaneous coronary intervention (PCI) combined with optimal medical therapy (n = 1149) or optimal medical therapy alone (n = 1138). Patients were followed for a median of 4.6 years (range, 2.5 to 7.0 years). The primary outcome was a composite of all-cause mortality and nonfatal myocardial infarction.
What was found
Primary composite events occurred in 211 patients (19.0% 4.6-year cumulative rate) in the PCI group compared with 202 patients (18.5%) in the medical-therapy group (hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.87 to 1.27; P = 0.62). There were no statistically significant differences between the PCI and medical-therapy groups for the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; HR, 1.05; 95% CI, 0.87 to 1.27; P = 0.62), hospitalization for acute coronary syndrome (12.4% vs. 11.8%; HR, 1.07; 95% CI, 0.84 to 1.37; P = 0.56), or myocardial infarction alone (13.2% vs. 12.3%; HR, 1.13; 95% CI, 0.89 to 1.43; P = 0.33).
Why it matters
This trial demonstrated that routine initial PCI provides no additional protection against death, myocardial infarction, or major ischemic events compared to intensive medical therapy alone in patients with stable coronary artery disease.
Limits
The abstract does not report crossover rates from medical therapy to revascularization, procedural complications, stent types, or symptom-relief outcomes such as angina frequency. The trial was restricted to patients with stable ischemic disease and does not apply to acute coronary syndromes.
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