Comparison of Drug-Coated Versus Conventional Balloons for the Side Branches of Bifurcation Lesions: OCVC-BIF Study
In brief
Drug-coated balloons cut side-branch restenosis from 18% to 8%
In a randomized trial of 299 patients with coronary bifurcation lesions, adding a drug-coated balloon for the side branch reduced restenosis from 18.3% to 8.1%. Major cardiac events at 12 months were similar between groups, so the lower restenosis rate has not yet translated into a demonstrated clinical benefit.
- Journal
- Circulation. Cardiovascular interventions (Q1)
- Published
- 29 May 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Takayuki Ishihara, Tomoharu Dohi, Daisuke Sakamoto, Hirota Kida, Naotaka Okamoto, Atsushi Kikuchi, et al.
- PMID
- 42900708
- DOI
- 10.1161/CIRCINTERVENTIONS.125.016424
Why clinicians should know about it
- Picked for Cardiology and Cardiovascular Medicine (paper of the day, 21 October 2026): Randomized coronary bifurcation intervention trial with clinical outcomes
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.