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 LimSeung-Woon Rha, Myung Ho Jeong, Bong Ki Lee, Damras Tresukosol, Guo Sheng Fu, Tiong Kiam Ong

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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.

Original languageEnglish
Pages (from-to)1204-1212
Number of pages9
JournalNew England Journal of Medicine
Volume372
Issue number13
DOIs
Publication statusPublished - 2015 Mar 26

ASJC Scopus subject areas

  • Medicine(all)

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    Park, S. J., Ahn, J. M., Kim, Y. H., Park, D. W., Yun, S. C., Lee, J. Y., Kang, S. J., Lee, S. W., Lee, C. W., Park, S. W., Choo, S. J., Chung, C. H., Lee, J. W., Cohen, D. J., Yeung, A. C., Hur, S. H., Seung, K. B., Ahn, T. H., Kwon, H. M., ... Ong, T. K. (2015). Trial of everolimus-eluting stents or bypass surgery for coronary disease. New England Journal of Medicine, 372(13), 1204-1212. https://doi.org/10.1056/NEJMoa1415447