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Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial.
This is a prospective, randomised, open-label, non-inferiority trial comparing CABG versus PCI in patients with unprotected left main stenosis. The study was carried out at 36 hospitals in Latvia, Estonia, Lithuania, Germany, Norway, Sweden, Finland, the UK, and Denmark. In total, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat up to 5 years of follow up. Interestingly, only 8% of the patients in the CABG group had the right internal mammary artery used as a graft (93% had the left ITA used). The primary endpoint was a composite of major adverse cardiac and cerebrovascular events (MACCE; death from any cause, non-procedural myocardial infarction,14 repeat revascularisation, or stroke). The key findings of the NOBLE study are that CABG was better than PCI for the composite endpoint of MACCE; all-cause mortality was similar between the two groups; non-procedural myocardial infarction and need for repeat revascularisation were increased after PCI; a higher rate of stroke was observed in the CABG group after 30 days than in the PCI group, but an unexpected, numerically higher rate of stroke was found in PCI-treated patients in 5 year estimates; maximum angina pectoris score was higher after PCI at up to 5 years follow-up.