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Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31.

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

Author information

1
Department of Cardiology, Oulu University Hospital, Oulu, Finland.
2
Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
3
Department of Cardiology, Golden Jubilee National Hospital, Clydebank, Scotland.
4
Belfast Heart Centre, Belfast Trust, Belfast, Northern Ireland.
5
Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia.
6
Craigavon Cardiac Centre, Craigavon, Northern Ireland.
7
Department of Cardiology, University of Northern Norway, Tromsø, Norway.
8
Heart Hospital, Tampere University Hospital, Tampere, Finland.
9
Heart Center, Kuopio University Hospital, Kuopio, Finland.
10
Department of Cardiology, Örebro University Hospital, Örebro, Sweden.
11
Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
12
Department of Cardiology, Odense University Hospital, Odense, Denmark.
13
Department of Cardiology, Vilnius University Hospital, Vilnius, Lithuania.
14
Department of Cardiology, Danderyd Hospital, Stockholm, Sweden.
15
Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.
16
Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
17
Oxford Heart Centre, Oxford, UK.
18
Department of Cardiology, Freeman Hospital and Institute of Cellular Medicine, Newcastle, UK.
19
Heart and Lung Centre, New Cross Hospital, Wolverhampton, UK.
20
Department of Cardiology, Haukeland University Hospital, Bergen, Norway.
21
Department of Cardiology, East Tallinn Hospital, Tallinn, Estonia.
22
Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; Department of Health Research and Policy (Epidemiology), Stanford University, Stanford, CA, USA.
23
Department of Cardiac Surgery, Aarhus University Hospital, Skejby, Aarhus, Denmark.
24
Department of Cardiovascular Surgery, University of Northern Norway, Tromsø, Norway.
25
Department of Cardiology, Karolinska University Hospital, Huddinge, Stockholm, Sweden.
26
Sussex Cardiac Centre, Brighton and Sussex University Hospital, Brighton, UK.
27
Department of Cardiac Surgery, Oulu University Hospital, Finland.
28
Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. Electronic address: evald.christiansen@dadlnet.dk.

Erratum in

Abstract

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.

PMID:
27810312
DOI:
10.1016/S0140-6736(16)32052-9
[Indexed for MEDLINE]

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