Cardiovascular

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

Ishihara T, Dohi T, et al. • Circulation. Cardiovascular interventions • 2026

PubMed 42900708 DOI 10.1161/CIRCINTERVENTIONS.125.016424
TL;DR

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.

Key Findings

Results

Side-branch restenosis was lower in the DCB group than in the non-DCB group.

  • The restenosis rate was 8.1% in the DCB group versus 18.3% in the non-DCB group (P=0.012).
  • Restenosis was defined as ≥50% stenosis of the side branch, determined using 3-dimensional bifurcation quantitative coronary angiography.
  • The primary end point was assessed using scheduled coronary angiography at 9 months or symptom-driven angiography during the 1-year follow-up.
Results

The incidence of major adverse cardiac events at 12 months was similar between the DCB and non-DCB groups.

  • MACE occurred in 10.1% versus 12.4% (P=0.58).
  • MACE was defined as a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization, and stent thrombosis.
  • This was a key secondary end point.
Methods

The trial randomized 299 patients with bifurcation lesions to DCB or non-DCB treatment, and most had serial angiographic evaluation.

  • 151 patients were assigned to the DCB group and 148 to the non-DCB group, enrolled between October 2019 and September 2024.
  • Serial 3-dimensional bifurcation quantitative coronary angiography was performed in 262 (87.6%) patients.
  • The study was a multicenter, randomized, open-label trial.
Methods

The study compared two treatment strategies for bifurcation lesions in which DES was implanted in the main vessel followed by kissing balloon inflation.

  • The DCB group received additional side-branch dilatation with a DCB after DES implantation and kissing balloon inflation.
  • The non-DCB group received only DES implantation with kissing balloon inflation using conventional balloons.

What This Means

This trial looked at how to better treat narrowed heart arteries at a fork (a bifurcation), where a smaller side branch splits off from the main vessel. The side branch is a common place for the artery to narrow again after treatment. In 299 patients who received a stent in the main vessel and a kissing balloon technique, half-ish were randomly assigned to also have the side branch treated with a drug-coated balloon, which delivers medication to the artery wall, while the others received only the standard approach. About 8% of patients who received the drug-coated balloon had the side branch narrow again, compared with about 18% of those who did not. However, the overall rate of major heart events over 12 months (cardiac death, heart attack, repeat procedures driven by symptoms, and stent clots) was similar, about 10% versus 12%, and this difference could have been due to chance. This research suggests that adding a drug-coated balloon to the side branch can reduce re-narrowing seen on angiography, though in this study it did not clearly change broader clinical events at one year. The trial was open-label, meaning patients and doctors knew which treatment was used, and results are limited to the study population and follow-up period.

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Citation

Ishihara T, Dohi T, Sakamoto D, Kida H, Okamoto N, Kikuchi A, et al.. (2026). Comparison of Drug-Coated Versus Conventional Balloons for the Side Branches of Bifurcation Lesions: OCVC-BIF Study.. Circulation. Cardiovascular interventions. https://doi.org/10.1161/CIRCINTERVENTIONS.125.016424