Randomized trial of stents versus bypass surgery for left main coronary artery disease

Seung Jung Park, Young Hak Kim, Duk Woo Park, Sung Cheol Yun, Jung Min Ahn, Hae Geun Song, Jong Young Lee, Won Jang Kim, Soo Jin Kang, Seung Whan Lee, Cheol Whan Lee, Seong Wook Park, Cheol Hyun Chung, Jae Won Lee, Do Sun Lim, Seung Woon Rha, Sang Gon Lee, Hyeon Cheol Gwon, Hyo Soo Kim, In Ho ChaeYangsoo Jang, Myung Ho Jeong, Seung Jea Tahk, Ki Bae Seung

Research output: Contribution to journalArticle

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Abstract

BACKGROUND Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice. METHODS We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups. RESULTS The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P = 0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P = 0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P = 0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P = 0.02). CONCLUSIONS In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others; PRECOMBAT ClinicalTrials.gov number, NCT00422968.)

Original languageEnglish
Pages (from-to)1718-1727
Number of pages10
JournalNew England Journal of Medicine
Volume364
Issue number18
DOIs
Publication statusPublished - 2011 May 5

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Stents
Coronary Artery Disease
Percutaneous Coronary Intervention
Coronary Artery Bypass
Coronary Stenosis
Confidence Intervals
Sirolimus
Stroke
Myocardial Infarction
Korea
Myocardial Ischemia
Cause of Death
Ischemia
Mortality
Research

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Park, S. J., Kim, Y. H., Park, D. W., Yun, S. C., Ahn, J. M., Song, H. G., ... Seung, K. B. (2011). Randomized trial of stents versus bypass surgery for left main coronary artery disease. New England Journal of Medicine, 364(18), 1718-1727. https://doi.org/10.1056/NEJMoa1100452
Park, Seung Jung ; Kim, Young Hak ; Park, Duk Woo ; Yun, Sung Cheol ; Ahn, Jung Min ; Song, Hae Geun ; Lee, Jong Young ; Kim, Won Jang ; Kang, Soo Jin ; Lee, Seung Whan ; Lee, Cheol Whan ; Park, Seong Wook ; Chung, Cheol Hyun ; Lee, Jae Won ; Lim, Do Sun ; Rha, Seung Woon ; Lee, Sang Gon ; Gwon, Hyeon Cheol ; Kim, Hyo Soo ; Chae, In Ho ; Jang, Yangsoo ; Jeong, Myung Ho ; Tahk, Seung Jea ; Seung, Ki Bae. / Randomized trial of stents versus bypass surgery for left main coronary artery disease. In: New England Journal of Medicine. 2011 ; Vol. 364, No. 18. pp. 1718-1727.
@article{376b3edb345b45bba7eb2bf248fb9685,
title = "Randomized trial of stents versus bypass surgery for left main coronary artery disease",
abstract = "BACKGROUND Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice. METHODS We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups. RESULTS The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7{\%} vs. 6.7{\%}; absolute risk difference, 2.0 percentage points; 95{\%} confidence interval [CI], -1.6 to 5.6; P = 0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2{\%} vs. 8.1{\%}; hazard ratio with PCI, 1.50; 95{\%} CI, 0.90 to 2.52; P = 0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4{\%} and 4.7{\%}, respectively; hazard ratio, 0.92; 95{\%} CI, 0.43 to 1.96; P = 0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0{\%} vs. 4.2{\%}; hazard ratio, 2.18; 95{\%} CI, 1.10 to 4.32; P = 0.02). CONCLUSIONS In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others; PRECOMBAT ClinicalTrials.gov number, NCT00422968.)",
author = "Park, {Seung Jung} and Kim, {Young Hak} and Park, {Duk Woo} and Yun, {Sung Cheol} and Ahn, {Jung Min} and Song, {Hae Geun} and Lee, {Jong Young} and Kim, {Won Jang} and Kang, {Soo Jin} and Lee, {Seung Whan} and Lee, {Cheol Whan} and Park, {Seong Wook} and Chung, {Cheol Hyun} and Lee, {Jae Won} and Lim, {Do Sun} and Rha, {Seung Woon} and Lee, {Sang Gon} and Gwon, {Hyeon Cheol} and Kim, {Hyo Soo} and Chae, {In Ho} and Yangsoo Jang and Jeong, {Myung Ho} and Tahk, {Seung Jea} and Seung, {Ki Bae}",
year = "2011",
month = "5",
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doi = "10.1056/NEJMoa1100452",
language = "English",
volume = "364",
pages = "1718--1727",
journal = "New England Journal of Medicine",
issn = "0028-4793",
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}

Park, SJ, Kim, YH, Park, DW, Yun, SC, Ahn, JM, Song, HG, Lee, JY, Kim, WJ, Kang, SJ, Lee, SW, Lee, CW, Park, SW, Chung, CH, Lee, JW, Lim, DS, Rha, SW, Lee, SG, Gwon, HC, Kim, HS, Chae, IH, Jang, Y, Jeong, MH, Tahk, SJ & Seung, KB 2011, 'Randomized trial of stents versus bypass surgery for left main coronary artery disease', New England Journal of Medicine, vol. 364, no. 18, pp. 1718-1727. https://doi.org/10.1056/NEJMoa1100452

Randomized trial of stents versus bypass surgery for left main coronary artery disease. / Park, Seung Jung; Kim, Young Hak; Park, Duk Woo; Yun, Sung Cheol; Ahn, Jung Min; Song, Hae Geun; Lee, Jong Young; Kim, Won Jang; Kang, Soo Jin; Lee, Seung Whan; Lee, Cheol Whan; Park, Seong Wook; Chung, Cheol Hyun; Lee, Jae Won; Lim, Do Sun; Rha, Seung Woon; Lee, Sang Gon; Gwon, Hyeon Cheol; Kim, Hyo Soo; Chae, In Ho; Jang, Yangsoo; Jeong, Myung Ho; Tahk, Seung Jea; Seung, Ki Bae.

In: New England Journal of Medicine, Vol. 364, No. 18, 05.05.2011, p. 1718-1727.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomized trial of stents versus bypass surgery for left main coronary artery disease

AU - Park, Seung Jung

AU - Kim, Young Hak

AU - Park, Duk Woo

AU - Yun, Sung Cheol

AU - Ahn, Jung Min

AU - Song, Hae Geun

AU - Lee, Jong Young

AU - Kim, Won Jang

AU - Kang, Soo Jin

AU - Lee, Seung Whan

AU - Lee, Cheol Whan

AU - Park, Seong Wook

AU - Chung, Cheol Hyun

AU - Lee, Jae Won

AU - Lim, Do Sun

AU - Rha, Seung Woon

AU - Lee, Sang Gon

AU - Gwon, Hyeon Cheol

AU - Kim, Hyo Soo

AU - Chae, In Ho

AU - Jang, Yangsoo

AU - Jeong, Myung Ho

AU - Tahk, Seung Jea

AU - Seung, Ki Bae

PY - 2011/5/5

Y1 - 2011/5/5

N2 - BACKGROUND Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice. METHODS We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups. RESULTS The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P = 0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P = 0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P = 0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P = 0.02). CONCLUSIONS In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others; PRECOMBAT ClinicalTrials.gov number, NCT00422968.)

AB - BACKGROUND Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice. METHODS We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups. RESULTS The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P = 0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P = 0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P = 0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P = 0.02). CONCLUSIONS In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others; PRECOMBAT ClinicalTrials.gov number, NCT00422968.)

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DO - 10.1056/NEJMoa1100452

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