Abstract
The clinical utility of establishing late patency of the persistently occluded infarct-related artery with percutaneous coronary intervention (PCI) was uncertain. The Occluded Artery Trial was a National Heart, Lung, and Blood Institute-supported, international, multicenter, randomized controlled trial comparing a test strategy of late PCI (3-28 days) of the occluded infarct-related artery and optimal medical therapy to optimal medical therapy alone. The primary end point of the trial was a centrally adjudicated composite of death, reinfarction, and New York Heart Association class IV heart failure over 4 years (mean follow-up, 1,059 +/- 11 days). The final study population of 2,166 patients gave the trial 94% power to detect the anticipated 25% reduction in event rate with PCI. The combined primary outcome occurred in 161 patients in the PCI group and in 140 subjects receiving medical therapy alone. The 4-year cumulative primary event rate was 17.2% in the PCI group and 15.6% in the medical therapy group (hazard ratio, 1.16; 95% confidence interval, 0.92-1.45; P = .20; covariate-adjusted hazard ratio, 1.17; 95% confidence interval, 0.93 to 1.47; P = .18). Rates of New York Heart Association class IV heart failure and death were similar in both groups. A trend toward increased nonfatal myocardial infarction in the PCI group (hazard ratio, 1.44; 95% confidence interval, 0.96-2.16; P = .08) unrelated to periprocedural events was apparent. No significant interaction between treatment effect and prespecified subgroups was observed. This lack of clinical benefit supports optimal medical therapy alone for Occluded Artery Trial-eligible patients in current clinical practice.