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

Research output: Contribution to journalArticle

200 Citations (Scopus)

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

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Percutaneous Coronary Intervention
Stents
Coronary Disease
Myocardial Infarction
Coronary Artery Disease
Confidence Intervals
Drug-Eluting Stents
Far East
Random Allocation
Everolimus
Stroke
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Park, S. J., Ahn, J. M., Kim, Y. H., Park, D. W., Yun, S. C., Lee, J. Y., ... 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

Trial of everolimus-eluting stents or bypass surgery for coronary disease. / Park, Seung Jung; Ahn, Jung Min; Kim, Young Hak; Park, Duk Woo; Yun, Sung Cheol; Lee, Jong Young; Kang, Soo Jin; Lee, Seung Whan; Lee, Cheol Whan; Park, Seong Wook; Choo, Suk Jung; Chung, Cheol Hyun; Lee, Jae Won; Cohen, David J.; Yeung, Alan C.; Hur, Seung Ho; Seung, Ki Bae; Ahn, Tae Hoon; Kwon, Hyuck Moon; Lim, Do-Sun; Rha, Seung-Woon; Jeong, Myung Ho; Lee, Bong Ki; Tresukosol, Damras; Fu, Guo Sheng; Ong, Tiong Kiam.

In: New England Journal of Medicine, Vol. 372, No. 13, 26.03.2015, p. 1204-1212.

Research output: Contribution to journalArticle

Park, SJ, Ahn, JM, Kim, YH, Park, DW, Yun, SC, Lee, JY, Kang, SJ, Lee, SW, Lee, CW, Park, SW, Choo, SJ, Chung, CH, Lee, JW, Cohen, DJ, Yeung, AC, Hur, SH, Seung, KB, Ahn, TH, Kwon, HM, Lim, D-S, Rha, S-W, Jeong, MH, Lee, BK, Tresukosol, D, Fu, GS & Ong, TK 2015, 'Trial of everolimus-eluting stents or bypass surgery for coronary disease', New England Journal of Medicine, vol. 372, no. 13, pp. 1204-1212. https://doi.org/10.1056/NEJMoa1415447
Park, Seung Jung ; Ahn, Jung Min ; Kim, Young Hak ; Park, Duk Woo ; Yun, Sung Cheol ; Lee, Jong Young ; Kang, Soo Jin ; Lee, Seung Whan ; Lee, Cheol Whan ; Park, Seong Wook ; Choo, Suk Jung ; Chung, Cheol Hyun ; Lee, Jae Won ; Cohen, David J. ; Yeung, Alan C. ; Hur, Seung Ho ; Seung, Ki Bae ; Ahn, Tae Hoon ; Kwon, Hyuck Moon ; Lim, Do-Sun ; Rha, Seung-Woon ; Jeong, Myung Ho ; Lee, Bong Ki ; Tresukosol, Damras ; Fu, Guo Sheng ; Ong, Tiong Kiam. / Trial of everolimus-eluting stents or bypass surgery for coronary disease. In: New England Journal of Medicine. 2015 ; Vol. 372, No. 13. pp. 1204-1212.
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T1 - Trial of everolimus-eluting stents or bypass surgery for coronary disease

AU - Park, Seung Jung

AU - Ahn, Jung Min

AU - Kim, Young Hak

AU - Park, Duk Woo

AU - Yun, Sung Cheol

AU - Lee, Jong Young

AU - Kang, Soo Jin

AU - Lee, Seung Whan

AU - Lee, Cheol Whan

AU - Park, Seong Wook

AU - Choo, Suk Jung

AU - Chung, Cheol Hyun

AU - Lee, Jae Won

AU - Cohen, David J.

AU - Yeung, Alan C.

AU - Hur, Seung Ho

AU - Seung, Ki Bae

AU - Ahn, Tae Hoon

AU - Kwon, Hyuck Moon

AU - Lim, Do-Sun

AU - Rha, Seung-Woon

AU - Jeong, Myung Ho

AU - Lee, Bong Ki

AU - Tresukosol, Damras

AU - Fu, Guo Sheng

AU - Ong, Tiong Kiam

PY - 2015/3/26

Y1 - 2015/3/26

N2 - 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.

AB - 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.

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