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Comparison of drug-coated versus conventional balloons for the side branch of the bifurcation lesion - multicenter
Tomoharu Dohi1, Takayuki Ishihara2, Hirota Kida1
1Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita 565-0871, Japan.
Insights
This trial investigates if drug-coated balloons (DCB) improve outcomes for coronary bifurcation lesions compared to conventional balloons after main vessel stenting. It aims to establish the efficacy and safety of DCB in treating side-branch lesions.
Area of Science:
- Interventional Cardiology
- Vascular Medicine
- Biomedical Engineering
Background:
- Coronary bifurcation lesions pose treatment challenges.
- Drug-coated balloons (DCB) show potential for side-branch lesions, but evidence is limited.
- Efficacy and safety of DCB in this context require further investigation.
Purpose of the Study:
- To evaluate the superiority of additional DCB treatment for side branches compared to conventional balloon angioplasty.
- To assess the impact of DCB on restenosis rates in coronary bifurcation lesions.
- To compare major adverse cardiac events and anatomical outcomes between DCB and conventional balloon strategies.
Main Methods:
- Multicenter, randomized, open-label, controlled trial (OCVC-BIF).
- Compares DCB for side branch post-main vessel stenting + kissing balloon inflation (KBI) versus KBI with conventional balloons.
- Primary endpoint: side branch restenosis at 9-month angiography; secondary endpoints include MACE and OCT findings. 300 patients enrolled, 1-year follow-up.
Main Results:
- Data on main results are not yet available as the trial is ongoing.
- The study is designed to provide robust evidence on restenosis and clinical outcomes.
- Optical coherence tomography will offer detailed insights into lesion morphology and treatment effects.
Conclusions:
- The OCVC-BIF trial will determine if adding DCB to conventional treatment improves outcomes for coronary bifurcation lesions.
- Results will inform clinical practice regarding the use of DCB in complex PCI.
- This study aims to establish a new standard of care for side-branch interventions.
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.
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