Background In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events. Methods We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004. we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and non-fatal myocardial infarclion during a follow-up period of 2.5 to 7.0 years (median. 4.6] Results There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCl group. 1.05: 95% confidence interval |CI|. 0.87 to 1.27: P = 0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite ol death, myocardial infarction. and stroke (20.0% vs. 19.5% hazard ratio. 1.05: 95% Cl, 0.87 to 1.27; P = 0.62): hospitahzalion for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio. 1.07; 95% Cl, 0.84 to 1.37: P = 0.56); or myocardial infarclion (13.2% vs 12.3%; hazard ratio. 1.13 95% Cl. 0.89 to 1.43; P= 0.33). Conclusions As an initial management strategy in patients with stable coronary artery disease, PCl did not reduce the risk of death. myocardial infraction, or other major cardiovascular events when added to optimal medical therapy.
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