Comparison of Drug-Coated Versus Conventional Balloons for the Side Branches of Bifurcation Lesions: OCVC-BIF Study.

Abstract

Background: Coronary bifurcation lesions remain one of the most challenging lesions. In particular, satisfactory clinical outcomes have not yet been achieved for side branches. The use of drug-coated balloons (DCBs) has demonstrated acceptable clinical outcomes in native coronary arteries. This study aimed to evaluate the efficacy and safety of additional DCB inflation in the side branches of bifurcation lesions.

Methods: The OCVC-BIF study (Comparison of Drug-Coated Versus Conventional Balloons for the Side Branch of Bifurcation Lesions) was conducted as a multicenter, randomized, open-label trial. Patients with bifurcation lesions scheduled for drug-eluting stent (DES) implantation in the main vessel followed by kissing balloon inflation were enrolled in the study. The patients were randomized to receive either additional dilatation of the side branch using a DCB after DES implantation with kissing balloon inflation (DCB group) or only DES implantation with kissing balloon inflation using conventional balloons (non-DCB group). The primary end point was restenosis of the side branch, assessed using scheduled coronary angiography at 9 months or symptom-driven coronary angiography during the 1-year follow-up. Restenosis was defined as ≥50% stenosis of the side branch, determined using 3-dimensional bifurcation quantitative coronary angiography. The key secondary end points included major adverse cardiac events at 12 months, which were defined as a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization, and stent thrombosis.

Results: In total, 299 patients were randomized into the DCB (151 patients) and non-DCB (148 patients) groups between October 2019 and September 2024. Serial 3-dimensional bifurcation quantitative coronary angiography evaluation was performed in 262 (87.6%) patients. The restenosis rate was lower in the DCB group than that in the non-DCB group (8.1% versus 18.3%, P=0.012). However, the incidence of major adverse cardiac events at 12 months was similar between them (10.1% versus 12.4%, P=0.58).

Conclusions: Additional DCB inflation in the side branch after main-vessel DES implantation with kissing balloon inflation decreases restenosis in the side branch in the treatment of bifurcation lesions.

Registration: URL: https://jrct.mhlw.go.jp/en-latest-detail/jRCTs052200077; Unique identifier: jRCTs052200077.