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