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Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial

Lookup NU author(s): Professor Azfar Zaman



This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).


Background Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery (LMCA) disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of LMCA disease. Methods Patients with LMCA 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. 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% confidence interval (CI) not to exceed a hazard ratio (HR) of 1.35 after up to five years of follow–up. identifier: NCT01496651. Findings A total of 1201 patients were randomised, 598 to PCI and 603 to CABG, and 592 in each arm entered analysis by intention to treat. Kaplan–Meier five–year estimates of MACCE were 28·7% for PCI (121 events) and 20·1% for CABG (81 events), [HR 1·46 (95% CI 1·10–1·95)], exceeding the limit for non–inferiority and was significant for superiority of CABG over PCI (p=0·0079). As-treated estimates were 29·1% vs. 21·1% [HR 1·51 (95% CI 1·15–1·99), p=0·0032]. Comparing PCI to CABG, five–year estimates were 11·5% vs. 9·5% [HR 1·04 (95% CI 0·65–1·67), p=0·8625] for all–cause mortality; 6·9% vs. 1·9% [HR 2·9 (95% CI 1·40–5·90), p=0·000] for non–procedural myocardial infarction; 16·2% vs. 10·4% [HR 1·5 (95% CI 1·04–2·17), p=0·0315] for any revascularisation; and 4·9% vs. 1·7% [HR 2·3 (95% CI 0·92–5·48), p=0·0731] for stroke. Interpretation The findings of this study indicate that CABG may be superior to PCI for treatment of left main stem coronary artery disease.

Publication metadata

Author(s): Mäkikallio T, Holm NR, Lindsay M, Spence M, Erglis A, Menown IBA, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RBA, Pentikainen M, Hervold M, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sørensen HT, Nielsen PH, Niemelä M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Fröbert O, Graham ANJ, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH

Publication type: Article

Publication status: Published

Journal: Lancet

Year: 2016

Volume: 388

Issue: 10061

Pages: 2743-2752

Print publication date: 03/12/2016

Online publication date: 31/10/2016

Acceptance date: 09/10/2016

Date deposited: 08/03/2018

ISSN (print): 0140-6736

ISSN (electronic): 1474-547X

Publisher: Elsevier


DOI: 10.1016/S0140-6736(16)32052-9


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