Trial of Everolimus-Eluting Stents or Bypass Surgery for Coronary Disease

Authors
Seung-Jung ParkJung-Min AhnYoung-Hak KimDuk-Woo ParkSung-Cheol YunJong-Young LeeSoo-Jin KangSeung-Whan LeeCheol Whan LeeSeong-Wook ParkSuk Jung ChooCheol Hyun ChungJae Won LeeDavid J. CohenAlan C. YeungSeung Ho HurKi Bae SeungTae Hoon AhnHyuck Moon KwonDo-Sun LimSeung-Woon RhaMyung-Ho JeongBong-Ki LeeDamras TresukosolGuo Sheng FuTiong Kiam Ong
Department
Dept. of Internal Medicine (내과학)
Issue Date
2015
Citation
New England Journal of Medicine, Vol.372(13) : 1204-1212, 2015
ISSN
0028-4793
Abstract
BACKGROUND Most trials comparing percutaneous coronary intervention (PCI) with coronaryartery 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.)
URI
http://kumel.medlib.dsmc.or.kr/handle/2015.oak/33466
Appears in Collections:
1. Journal Papers (연구논문) > 1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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