![]() ![]() The PRECOMBAT trial was a prospective, open-label, randomized trial conducted at 13 sites in Korea. In the Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease (PRECOMBAT) trial, we compared PCI using sirolimus-eluting stents with CABG for revascularization in patients with unprotected left main coronary artery stenosis. 6,15 A recent small, randomized study, which failed to show the noninferiority of PCI as compared with CABG, was limited by inadequate statistical power. 14 The results observed in patients with left main coronary artery stenosis in the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery randomized substudy (SYNTAX number, NCT00114972), although hypothesis-generating, nonetheless indicate the need for further randomized studies, owing to the limitations of such subgroup analyses. Registry results have an inherent limitation of selection bias, preventing an accurate comparison of the two treatments. 12,13 Whether the outcomes after PCI are similar to those after CABG remains uncertain, however, owing to the lack of large, randomized clinical trials. 1-11 Recent clinical guidelines have accordingly stated that elective PCI can be considered for patients who have unprotected left main coronary artery disease, although they suggest that the aggregated evidence favors CABG. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others PRECOMBAT number, NCT00422968.) IntroductionĪ number of registry reports, as well as a substudy from a large, randomized trial, have indicated that percutaneous coronary intervention (PCI) may be an acceptable alternative to coronary-artery bypass grafting (CABG) in some patients with unprotected left main coronary artery stenosis. However, the noninferiority margin was wide, and the results cannot be considered clinically directive. In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively hazard ratio, 0.92 95% CI, 0.43 to 1.96 P=0.83). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 6.7% absolute risk difference, 2.0 percentage points 95% confidence interval, −1.6 to 5.6 P=0.01 for noninferiority). ![]() The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. Event rates at 2 years were also compared between the two groups. Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice. The most trusted, influential source of new medical knowledge and clinical best practices in the world. Information and tools for librarians about site license offerings. ![]() Valuable tools for building a rewarding career in health care. The authorized source of trusted medical research and education for the Chinese-language medical community. The most advanced way to teach, practice, and assess clinical reasoning skills. Information, resources, and support needed to approach rotations - and life as a resident. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. NEW! Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery.Ĭoncise summaries and expert physician commentary that busy clinicians need to enhance patient care. NEW! A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making. ![]()
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