Everolimus-eluting Stents or bypass surgery for left main coronary artery disease

Gregg W. Stone, Joseph F. Sabik, Patrick W. Serruys, Charles A. Simonton, Philippe Genereux, John Puskas, David E. Kandzari, Marie Claude Morice, Nicholas Lembo, W. Morris Brown, David P. Taggart, Adrian Banning, Béla Merkely, Ferenc Horkay, Piet W. Boonstra, Ad J. Van Boven, Imre Ungi, Gabor Bogáts, Samer Mansour, Nicolas Noiseux & 13 others Manel Sabaté, José Pomar, Mark Hickey, Anthony Gershlick, Pawel Buszman, Andrzej Bochenek, Erick Schampaert, Pierre Pagé, Ovidiu Dressler, Ioanna Kosmidou, Roxana Mehran, Stuart J. Pocock, A. Pieter Kappetein

Research output: Contribution to journalArticle

377 Citations (Scopus)

Abstract

BACKGROUND Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P = 0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P = 0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P = 0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P = 0.01 for noninferiority, P = 0.10 for superiority). CONCLUSIONS In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years.

Original languageEnglish (US)
Pages (from-to)2223-2235
Number of pages13
JournalNew England Journal of Medicine
Volume375
Issue number23
DOIs
StatePublished - Dec 8 2016

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Stents
Coronary Artery Disease
Coronary Artery Bypass
Percutaneous Coronary Intervention
Stroke
Myocardial Infarction
Myocardial Ischemia
Cause of Death
Everolimus
Taxus
Drug-Eluting Stents
Kaplan-Meier Estimate
Chromium
Cobalt
Thoracic Surgery
Coronary Disease
Anatomy
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Stone, G. W., Sabik, J. F., Serruys, P. W., Simonton, C. A., Genereux, P., Puskas, J., ... Kappetein, A. P. (2016). Everolimus-eluting Stents or bypass surgery for left main coronary artery disease. New England Journal of Medicine, 375(23), 2223-2235. https://doi.org/10.1056/NEJMoa1610227
Stone, Gregg W. ; Sabik, Joseph F. ; Serruys, Patrick W. ; Simonton, Charles A. ; Genereux, Philippe ; Puskas, John ; Kandzari, David E. ; Morice, Marie Claude ; Lembo, Nicholas ; Brown, W. Morris ; Taggart, David P. ; Banning, Adrian ; Merkely, Béla ; Horkay, Ferenc ; Boonstra, Piet W. ; Van Boven, Ad J. ; Ungi, Imre ; Bogáts, Gabor ; Mansour, Samer ; Noiseux, Nicolas ; Sabaté, Manel ; Pomar, José ; Hickey, Mark ; Gershlick, Anthony ; Buszman, Pawel ; Bochenek, Andrzej ; Schampaert, Erick ; Pagé, Pierre ; Dressler, Ovidiu ; Kosmidou, Ioanna ; Mehran, Roxana ; Pocock, Stuart J. ; Kappetein, A. Pieter. / Everolimus-eluting Stents or bypass surgery for left main coronary artery disease. In: New England Journal of Medicine. 2016 ; Vol. 375, No. 23. pp. 2223-2235.
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abstract = "BACKGROUND Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS At 3 years, a primary end-point event had occurred in 15.4{\%} of the patients in the PCI group and in 14.7{\%} of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5{\%} confidence limit, 4.0 percentage points; P = 0.02 for noninferiority; hazard ratio, 1.00; 95{\%} confidence interval, 0.79 to 1.26; P = 0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9{\%} of the patients in the PCI group and in 7.9{\%} in the CABG group (P<0.001 for noninferiority, P = 0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1{\%} of the patients in the PCI group and in 19.1{\%} in the CABG group (P = 0.01 for noninferiority, P = 0.10 for superiority). CONCLUSIONS In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years.",
author = "Stone, {Gregg W.} and Sabik, {Joseph F.} and Serruys, {Patrick W.} and Simonton, {Charles A.} and Philippe Genereux and John Puskas and Kandzari, {David E.} and Morice, {Marie Claude} and Nicholas Lembo and Brown, {W. Morris} and Taggart, {David P.} and Adrian Banning and B{\'e}la Merkely and Ferenc Horkay and Boonstra, {Piet W.} and {Van Boven}, {Ad J.} and Imre Ungi and Gabor Bog{\'a}ts and Samer Mansour and Nicolas Noiseux and Manel Sabat{\'e} and Jos{\'e} Pomar and Mark Hickey and Anthony Gershlick and Pawel Buszman and Andrzej Bochenek and Erick Schampaert and Pierre Pag{\'e} and Ovidiu Dressler and Ioanna Kosmidou and Roxana Mehran and Pocock, {Stuart J.} and Kappetein, {A. Pieter}",
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language = "English (US)",
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pages = "2223--2235",
journal = "New England Journal of Medicine",
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Stone, GW, Sabik, JF, Serruys, PW, Simonton, CA, Genereux, P, Puskas, J, Kandzari, DE, Morice, MC, Lembo, N, Brown, WM, Taggart, DP, Banning, A, Merkely, B, Horkay, F, Boonstra, PW, Van Boven, AJ, Ungi, I, Bogáts, G, Mansour, S, Noiseux, N, Sabaté, M, Pomar, J, Hickey, M, Gershlick, A, Buszman, P, Bochenek, A, Schampaert, E, Pagé, P, Dressler, O, Kosmidou, I, Mehran, R, Pocock, SJ & Kappetein, AP 2016, 'Everolimus-eluting Stents or bypass surgery for left main coronary artery disease', New England Journal of Medicine, vol. 375, no. 23, pp. 2223-2235. https://doi.org/10.1056/NEJMoa1610227

Everolimus-eluting Stents or bypass surgery for left main coronary artery disease. / Stone, Gregg W.; Sabik, Joseph F.; Serruys, Patrick W.; Simonton, Charles A.; Genereux, Philippe; Puskas, John; Kandzari, David E.; Morice, Marie Claude; Lembo, Nicholas; Brown, W. Morris; Taggart, David P.; Banning, Adrian; Merkely, Béla; Horkay, Ferenc; Boonstra, Piet W.; Van Boven, Ad J.; Ungi, Imre; Bogáts, Gabor; Mansour, Samer; Noiseux, Nicolas; Sabaté, Manel; Pomar, José; Hickey, Mark; Gershlick, Anthony; Buszman, Pawel; Bochenek, Andrzej; Schampaert, Erick; Pagé, Pierre; Dressler, Ovidiu; Kosmidou, Ioanna; Mehran, Roxana; Pocock, Stuart J.; Kappetein, A. Pieter.

In: New England Journal of Medicine, Vol. 375, No. 23, 08.12.2016, p. 2223-2235.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Everolimus-eluting Stents or bypass surgery for left main coronary artery disease

AU - Stone, Gregg W.

AU - Sabik, Joseph F.

AU - Serruys, Patrick W.

AU - Simonton, Charles A.

AU - Genereux, Philippe

AU - Puskas, John

AU - Kandzari, David E.

AU - Morice, Marie Claude

AU - Lembo, Nicholas

AU - Brown, W. Morris

AU - Taggart, David P.

AU - Banning, Adrian

AU - Merkely, Béla

AU - Horkay, Ferenc

AU - Boonstra, Piet W.

AU - Van Boven, Ad J.

AU - Ungi, Imre

AU - Bogáts, Gabor

AU - Mansour, Samer

AU - Noiseux, Nicolas

AU - Sabaté, Manel

AU - Pomar, José

AU - Hickey, Mark

AU - Gershlick, Anthony

AU - Buszman, Pawel

AU - Bochenek, Andrzej

AU - Schampaert, Erick

AU - Pagé, Pierre

AU - Dressler, Ovidiu

AU - Kosmidou, Ioanna

AU - Mehran, Roxana

AU - Pocock, Stuart J.

AU - Kappetein, A. Pieter

PY - 2016/12/8

Y1 - 2016/12/8

N2 - BACKGROUND Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P = 0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P = 0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P = 0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P = 0.01 for noninferiority, P = 0.10 for superiority). CONCLUSIONS In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years.

AB - BACKGROUND Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P = 0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P = 0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P = 0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P = 0.01 for noninferiority, P = 0.10 for superiority). CONCLUSIONS In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years.

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U2 - 10.1056/NEJMoa1610227

DO - 10.1056/NEJMoa1610227

M3 - Article

VL - 375

SP - 2223

EP - 2235

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 23

ER -