Abstract

Background: The Occluded Artery Trial (OAT) showed that a strategy of routine percutaneous coronary interventions (PCI) for occluded infarct-related coronary arteries identified up to 28 days post-MI does not reduce the primary end point of death, MI or class IV CHF compared to medical therapy alone (MED). However, PCI was not universally attempted in patients assigned PCI, and was not always successful when attempted. Moreover, some MED patients underwent early PCI. Using an as-treated analysis, we compared the outcomes of (1) successfully-treated PCI patients to medically-treated MED patients, and (2) PCI-assigned patients according to PCI success versus failure. Methods: Of 2201 patients randomized in OAT (2166 + 35 substudy), 1101 were assigned PCI and 1100 to MED. PCI assignment was categorized as attempted and successful (Success), attempted and unsuccessful (Fail), or No Attempt. MED assignment was categorized as medical only (Med Only) or crossover (X-Over) if PCI of the occlusion was performed in ≤30 days. Life table estimates of primary and secondary outcomes were calculated to compare as-treated categories. Results: Baseline characteristics of PCI Success and MED Only groups were similar. Compared to PCI Success, PCI Fail patients were more likely to be male, with higher rates of prior PCI, Killip Class 2– 4, and higher LV end-systolic sphericity index. No significant differences in primary or secondary outcomes were observed between PCI Success versus MED Only, or between PCI Success and PCI Fail. Med X-Over and PCI No Attempt groups were small. Conclusions: As-treated analysis does not reveal important differences in outcome, whether the comparison is between those with PCI success versus medical therapy alone, or between PCI success and PCI failure. These data indicate that the primary intention-to-treat results of OAT would not be altered by higher PCI success rates. 60-Month Life Table Event Rate Estimates

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