Comparison of drug-coated versus conventional balloons for the side branch of the bifurcation lesion - multicenter randomized controlled study - (OCVC-BIF): Design and rationale

Abstract

Background: Although several clinical trials have suggested the usefulness of drug-coated balloons (DCB) for side-branch lesions, their efficacy and safety have not yet been established.

Methods and study design: The Osaka Cardiovascular Conference (OCVC) will conduct a multicenter, randomized, open-label, controlled trial aiming to examine whether additional DCB treatment for the side branch after main vessel stenting followed by kissing balloon inflation (KBI) is superior to only KBI by conventional balloons in PCI patients with coronary bifurcation lesions. The primary endpoint is restenosis of side branches documented by scheduled or symptom-driven coronary angiography during 9-month follow-up period after the index PCI. The key secondary endpoints include major adverse cardiac event which consists of cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis, and optical coherence tomography findings. A total of 300 patients will be enrolled and followed up to 1 year.

Summary: The OCVC-BIF trial is a randomized controlled trial designed to assess whether additional DCB treatment for side branch is superior to only KBI by conventional balloons in patients with coronary bifurcation lesions undergoing PCI with main vessel stenting.

Keywords: Bifurcation; Coronary intervention; Drug-coated balloon; Open-label randomized controlled trial; Restenosis.