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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

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

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
[PubMed - in process]
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