The randomized, multicenter, open-label OCVC-BIF trial was conducted across eight hospitals in the Osaka region (Japan) and included 300 patients with coronary bifurcation lesions — defined by a side-branch diameter >2.0 mm or functional significance as determined by the operator — treated using a provisional stenting technique with kissing balloon inflation (KBI).
Patients were assigned either to side-branch dilation with a drug-coated balloon (DCB) or to conventional balloon angioplasty without DCB. The primary endpoint was ≥50 % restenosis in the side branch at nine months or the need for angiography prompted by symptoms within the first year.
Use of the DCB significantly reduced side-branch restenosis (OR 0.36; 95 % CI 0.16–0.79; p = 0.012) without increasing complications or adverse events. There were no differences in major adverse cardiac events (MACE) or stent thrombosis.
Conclusion
Side-branch dilation with a drug-coated balloon following main-vessel stenting significantly reduces restenosis and improves angiographic outcomes without increasing adverse events. These findings may influence bifurcation treatment strategies, supporting DCB use as a complement to the provisional approach and providing evidence for future clinical guideline updates.
Presented by Takayuki Ishihara et al., TCT 2025 (Late-Breaking Clinical Trials), October 27, San Francisco, USA.
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