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Trial of everolimus-eluting stents or bypass surgery for coronary disease

 Seung-Jung Park  ;  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 
 NEW ENGLAND JOURNAL OF MEDICINE, Vol.372(13) : 1204-1212, 2015 
Journal Title
Issue Date
Aged ; Coronary Artery Bypass* ; Coronary Artery Disease/surgery ; Coronary Artery Disease/therapy* ; Coronary Restenosis/epidemiology ; Diabetes Complications/therapy ; Drug-Eluting Stents* ; Everolimus ; Female ; Follow-Up Studies ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Myocardial Infarction/epidemiology ; Myocardial Infarction/prevention & control ; Percutaneous Coronary Intervention* ; Postoperative Complications ; Prospective Studies ; Sirolimus/administration & dosage ; Sirolimus/analogs & derivatives* ; Stroke/epidemiology
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.).
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kwon, Hyuck Moon(권혁문) ORCID logo https://orcid.org/0000-0001-9901-5015
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