Department of Clinical Medicine

TY - JOUR

T1 - Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE)

T2 - a prospective, randomised, open-label, non-inferiority trial

AU - Mäkikallio, Timo

AU - Holm, Niels R

AU - Lindsay, Mitchell

AU - Spence, Mark S

AU - Erglis, Andrejs

AU - Menown, Ian B A

AU - Trovik, Thor

AU - Eskola, Markku

AU - Romppanen, Hannu

AU - Kellerth, Thomas

AU - Ravkilde, Jan

AU - Jensen, Lisette O

AU - Kalinauskas, Gintaras

AU - Linder, Rikard B A

AU - Pentikainen, Markku

AU - Hervold, Anders

AU - Banning, Adrian

AU - Zaman, Azfar

AU - Cotton, Jamen

AU - Eriksen, Erlend

AU - Margus, Sulev

AU - Sørensen, Henrik T

AU - Nielsen, Per H

AU - Niemelä, Matti

AU - Kervinen, Kari

AU - Lassen, Jens F

AU - Maeng, Michael

AU - Oldroyd, Keith

AU - Berg, Geoff

AU - Walsh, Simon J

AU - Hanratty, Colm G

AU - Kumsars, Indulis

AU - Stradins, Peteris

AU - Steigen, Terje K

AU - Fröbert, Ole

AU - Graham, Alastair N J

AU - Endresen, Petter C

AU - Corbascio, Matthias

AU - Kajander, Olli

AU - Trivedi, Uday

AU - Hartikainen, Juha

AU - Anttila, Vesa

AU - Hildick-Smith, David

AU - Thuesen, Leif

AU - Christiansen, Evald H

AU - NOBLE study investigators

N1 - Copyright © 2016 Elsevier Ltd. All rights reserved.

PY - 2016/10/28

Y1 - 2016/10/28

N2 - BACKGROUND: Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease.METHODS: In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651.FINDINGS: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11-1·96), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18-2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67-1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40-5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04-2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93-5·48, p=0·073) for stroke.INTERPRETATION: The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease.FUNDING: Biosensors, Aarhus University Hospital, and participating sites.

AB - BACKGROUND: Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease.METHODS: In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651.FINDINGS: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11-1·96), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18-2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67-1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40-5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04-2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93-5·48, p=0·073) for stroke.INTERPRETATION: The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease.FUNDING: Biosensors, Aarhus University Hospital, and participating sites.

U2 - 10.1016/S0140-6736(16)32052-9

DO - 10.1016/S0140-6736(16)32052-9

M3 - Journal article

C2 - 27810312

VL - 388

SP - 2743

EP - 2752

JO - Lancet

JF - Lancet

SN - 0140-6736

IS - 10061

ER -