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

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  • Timo Mäkikallio, University of Oulu
  • ,
  • Niels R Holm
  • Mitchell Lindsay, Department of Cardiology, Golden Jubilee National Hospital, Clydebank, Scotland.
  • ,
  • Mark S Spence, Belfast Heart Centre, Belfast Trust, Belfast, Northern Ireland.
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  • Andrejs Erglis, Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia.
  • ,
  • Ian B A Menown, Craigavon Cardiac Centre, Craigavon, Northern Ireland.
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  • Thor Trovik, Department of Cardiology, University of Northern Norway, Tromsø, Norway.
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  • Markku Eskola, Tampere University
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  • Hannu Romppanen, Heart Center, Kuopio University Hospital, Kuopio, Finland.
  • ,
  • Thomas Kellerth, Örebro University
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  • Jan Ravkilde, Aalborg University
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  • Lisette O Jensen, University of Southern Denmark
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  • Gintaras Kalinauskas, Vilnius University
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  • Rikard B A Linder, Department of Cardiology, Danderyd Hospital, Stockholm, Sweden.
  • ,
  • Markku Pentikainen, Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.
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  • Anders Hervold, University of Oslo
  • ,
  • Adrian Banning, Oxford Heart Centre, Oxford, UK.
  • ,
  • Azfar Zaman, Department of Cardiology, Freeman Hospital and Institute of Cellular Medicine, Newcastle, UK.
  • ,
  • Jamen Cotton, Heart and Lung Centre, New Cross Hospital, Wolverhampton, UK.
  • ,
  • Erlend Eriksen, University of Bergen
  • ,
  • Sulev Margus, Department of Cardiology, East Tallinn Hospital, Tallinn, Estonia.
  • ,
  • Henrik T Sørensen
  • ,
  • Per H Nielsen
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  • Matti Niemelä, University of Oulu
  • ,
  • Kari Kervinen, University of Oulu
  • ,
  • Jens F Lassen
  • ,
  • Michael Maeng
  • Keith Oldroyd, Department of Cardiology, Golden Jubilee National Hospital, Clydebank, Scotland.
  • ,
  • Geoff Berg, Department of Cardiology, Golden Jubilee National Hospital, Clydebank, Scotland.
  • ,
  • Simon J Walsh, Belfast Heart Centre, Belfast Trust, Belfast, Northern Ireland.
  • ,
  • Colm G Hanratty, Belfast Heart Centre, Belfast Trust, Belfast, Northern Ireland.
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  • Indulis Kumsars, Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia.
  • ,
  • Peteris Stradins, Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia.
  • ,
  • Terje K Steigen, Department of Cardiology, University of Northern Norway, Tromsø, Norway.
  • ,
  • Ole Fröbert, Örebro University
  • ,
  • Alastair N J Graham, Belfast Heart Centre, Belfast Trust, Belfast, Northern Ireland.
  • ,
  • Petter C Endresen, Department of Cardiovascular Surgery, University of Northern Norway, Tromsø, Norway.
  • ,
  • Matthias Corbascio, Department of Cardiology, Karolinska University Hospital, Huddinge, Stockholm, Sweden.
  • ,
  • Olli Kajander, Tampere University
  • ,
  • Uday Trivedi, Brighton and Sussex University Hospitals NHS Trust
  • ,
  • Juha Hartikainen, Heart Center, Kuopio University Hospital, Kuopio, Finland.
  • ,
  • Vesa Anttila, University of Oulu
  • ,
  • David Hildick-Smith, Brighton and Sussex University Hospitals NHS Trust
  • ,
  • Leif Thuesen, Aalborg University
  • ,
  • Evald H Christiansen
  • NOBLE study investigators

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.

Original languageEnglish
JournalLancet
Volume388
Issue10061
Pages (from-to)2743–2752
Number of pages10
ISSN0140-6736
DOIs
Publication statusPublished - 28 Oct 2016

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