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



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.



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.



The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease.



Biosensors, Aarhus University Hospital, and participating sites.
Department of Cardiology, Oulu University Hospital, Oulu, Finland.
Timo
T
Mäkikallio
Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
Niels R
NR
Holm
Department of Cardiology, Golden Jubilee National Hospital, Clydebank, Scotland.
Mitchell
M
Lindsay
Belfast Heart Centre, Belfast Trust, Belfast, Northern Ireland.
Mark S
MS
Spence
Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia.
Andrejs
A
Erglis
Craigavon Cardiac Centre, Craigavon, Northern Ireland.
Ian B A
IB
Menown
Department of Cardiology, University of Northern Norway, Tromsø, Norway.
Thor
T
Trovik
Heart Hospital, Tampere University Hospital, Tampere, Finland.
Markku
M
Eskola
Heart Center, Kuopio University Hospital, Kuopio, Finland.
Hannu
H
Romppanen
Department of Cardiology, Örebro University Hospital, Örebro, Sweden.
Thomas
T
Kellerth
Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
Jan
J
Ravkilde
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Lisette O
LO
Jensen
Department of Cardiology, Vilnius University Hospital, Vilnius, Lithuania.
Gintaras
G
Kalinauskas
Department of Cardiology, Danderyd Hospital, Stockholm, Sweden.
Rikard B A
RB
Linder
Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.
Markku
M
Pentikainen
Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
Anders
A
Hervold
Oxford Heart Centre, Oxford, UK.
Adrian
A
Banning
Department of Cardiology, Freeman Hospital and Institute of Cellular Medicine, Newcastle, UK.
Azfar
A
Zaman
Heart and Lung Centre, New Cross Hospital, Wolverhampton, UK.
Jamen
J
Cotton
Department of Cardiology, Haukeland University Hospital, Bergen, Norway.
Erlend
E
Eriksen
Department of Cardiology, East Tallinn Hospital, Tallinn, Estonia.
Sulev
S
Margus
Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; Department of Health Research and Policy (Epidemiology), Stanford University, Stanford, CA, USA.
Henrik T
HT
Sørensen
Department of Cardiac Surgery, Aarhus University Hospital, Skejby, Aarhus, Denmark.
Per H
PH
Nielsen
Department of Cardiology, Oulu University Hospital, Oulu, Finland.
Matti
M
Niemelä
Department of Cardiology, Oulu University Hospital, Oulu, Finland.
Kari
K
Kervinen
Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
Jens F
JF
Lassen
Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
Michael
M
Maeng
Department of Cardiology, Golden Jubilee National Hospital, Clydebank, Scotland.
Keith
K
Oldroyd
Department of Cardiology, Golden Jubilee National Hospital, Clydebank, Scotland.
Geoff
G
Berg
Belfast Heart Centre, Belfast Trust, Belfast, Northern Ireland.
Simon J
SJ
Walsh
Belfast Heart Centre, Belfast Trust, Belfast, Northern Ireland.
Colm G
CG
Hanratty
Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia.
Indulis
I
Kumsars
Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia.
Peteris
P
Stradins
Department of Cardiology, University of Northern Norway, Tromsø, Norway.
Terje K
TK
Steigen
Department of Cardiology, Örebro University Hospital, Örebro, Sweden.
Ole
O
Fröbert
Belfast Heart Centre, Belfast Trust, Belfast, Northern Ireland.
Alastair N J
AN
Graham
Department of Cardiovascular Surgery, University of Northern Norway, Tromsø, Norway.
Petter C
PC
Endresen
Department of Cardiology, Karolinska University Hospital, Huddinge, Stockholm, Sweden.
Matthias
M
Corbascio
Heart Hospital, Tampere University Hospital, Tampere, Finland.
Olli
O
Kajander
Sussex Cardiac Centre, Brighton and Sussex University Hospital, Brighton, UK.
Uday
U
Trivedi
Heart Center, Kuopio University Hospital, Kuopio, Finland.
Juha
J
Hartikainen
Department of Cardiac Surgery, Oulu University Hospital, Finland.
Vesa
V
Anttila
Sussex Cardiac Centre, Brighton and Sussex University Hospital, Brighton, UK.
David
D
Hildick-Smith
Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
Leif
L
Thuesen
Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. Electronic address: evald.christiansen@dadlnet.dk.
Evald H
EH
Christiansen
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000592:standards; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D009203:Myocardial Infarction; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D020521:Stroke; D016896:Treatment Outcome