Seung-Jung Park1, Jung-Min Ahn, Young-Hak Kim, Duk-Woo Park, Sung-Cheol Yun, Jong-Young Lee, Soo-Jin Kang, Seung-Whan Lee, Cheol Whan Lee, Seong-Wook Park, Suk Jung Choo, Cheol Hyun Chung, Jae Won Lee, David J Cohen, Alan C Yeung, Seung Ho Hur, Ki Bae Seung, Tae Hoon Ahn, Hyuck Moon Kwon, Do-Sun Lim, Seung-Woon Rha, Myung-Ho Jeong, Bong-Ki Lee, Damras Tresukosol, Guo Sheng Fu, Tiong Kiam Ong. 1. From the Heart Institute (S.-J.P., J.-M.A., Y.-H.K., D.-W.P., J.-Y.L., S.-J.K., S.-W.L., C.W.L., S.-W.P., S.J.C., C.H.C., J.W.L.) and Division of Biostatistics (S.-C.Y.), Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Catholic University of Korea, St. Mary's Hospital (K.B.S.), Gangnam Severance Hospital (H.M.K.), Korea University Anam (D.-S.L.), and Guro Hospital (S.-W.R.), Seoul, Keimyung University Dongsan Medical Center, Daegu (S.H.H.), Gachon University Gil Hospital, Incheon (T.H.A.), Chonnam National University Hospital, Gwangju (M.-H.J.), and Kangwon National University Hospital, Chuncheon (B.-K.L.) - all in South Korea; Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (D.J.C.); Stanford University School of Medicine, Palo Alto, CA (A.C.Y.); Siriraj Hospital, Bangkok, Thailand (D.T.); Sir Run Run Shaw Hospital, Hangzhou, China (G.S.F.); and Sarawak General Hospital, Kuching, Malaysia (T.K.O.).
Abstract
BACKGROUND: Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents. METHODS: We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI witheverolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups. RESULTS: After the enrollment of 880 patients (438 patients randomly assigned to thePCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG. CONCLUSIONS: Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).
RCT Entities:
BACKGROUND: Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents. METHODS: We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups. RESULTS: After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG. CONCLUSIONS: Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).