The European Bifurcation Club Left Main Study (EBC MAIN): rationale and design of an international, multicentre, randomised comparison of two stent strategies for the treatment of left main coronary bifurcation disease

Abstract

Our aim is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions. The EBC MAIN study is a prospective, multinational, randomised clinical study of left main stem true bifurcation lesions (type 1,1,1 or 0,1,1: both left anterior descending and circumflex artery >2.75 mm diameter). The study hypothesis is that left main coronary bifurcation lesions are best treated with a planned single-stent strategy rather than a planned dual-stent strategy, with respect to death, target lesion revascularisation and myocardial infarction at one year. A total of 450 patients will be enrolled and treated either with a planned single or a planned dual zotarolimus-eluting stent strategy according to randomisation. The primary study endpoint is a composite of death, myocardial infarction and target lesion revascularisation at 12 months. Secondary endpoints are: death, myocardial infarctions, and target lesion revascularisation, each at 12 months; angina status, stent thrombosis, death, myocardial infarction, target lesion revascularisation at three- and five-year clinical follow-up. EBC MAIN will be the first randomised clinical trial to compare single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.