Trial of Everolimus-Eluting Stents or Bypass Surgery for Coronary Disease
- Author(s)
- 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
- Keimyung Author(s)
- Hur, Seung Ho
- Department
- Dept. of Internal Medicine (내과학)
- Journal Title
- New England Journal of Medicine
- Issued Date
- 2015
- Volume
- 372
- Issue
- 13
- 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.)
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