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

Aims: 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.

Methods and results: 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.

Conclusions: 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.