DCB-BIF Trial Results Favor Use of Drug-Coated Balloons to Rescue Jeopardized Side-branches After Provisional Bifurcation Stenting

The use of drug-coated balloons (DCBs) in coronary interventions has gained momentum, particularly with the recent FDA approval of the first DCB for coronary use in the United States. By combining balloon angioplasty with antiproliferative drug delivery, the promise of coronary DCBs lies in avoiding coronary stent implantation and downstream stent-related complications such as in-stent restenosis. The possibility of using DCBs to rescue side branches during provisional coronary bifurcation stenting is particularly attractive.

Bifurcation lesions account for nearly one in every five coronary interventions. Provisional stenting is a widely accepted strategy for simple true bifurcation lesions. However, managing the pinched side branch remains a technical challenge, particularly for the large branches subtending large portions of the myocardium.

DCBs, which deliver drugs like paclitaxel to inhibit neointimal hyperplasia, have demonstrated efficacy in de novo coronary lesions and in-stent restenosis in previous trials, including the AGENT IDE trial. However, their role in the context of bifurcation stenting remains underexplored, particularly for side branches pinched during provisional stenting.

Gao and colleagues recently published the multicenter randomized DCB-BIF Trial results, a randomized controlled trial enrolling patients undergoing provisional stenting for coronary bifurcation lesions. Following main branch stenting, patients with a compromised side branch (≥70% ostial stenosis) were treated with either standard noncompliant balloon (NCB) angioplasty or a DCB. The primary endpoint was major adverse cardiac events, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target-lesion revascularization at 1-year follow-up. The trial enrolled 784 patients, of which 391 were treated with DCB and 393 with NCB.

Results were promising for the DCB cohort. The study demonstrated a significant reduction in the one-year MACE rate in the DCB group compared to the standard balloon angioplasty group (Kaplan-Meier rate: 7.2% vs 12.5%; HR: 0.56; 95% CI: 0.35-0.88; P = 0.013), driven by a reduction in myocardial infarction in the DCB group. Curiously, periprocedural events contributed to a significant portion of this difference, which would not be an expected benefit of antiproliferative drug delivery, and calls into question the actual mechanism driving this clinical difference. For instance, could the longer balloon inflation times mandated for DCB have conferred some of the endpoint reduction rather than the drug itself? Of note, intracoronary imaging was used in less than a third of procedures.

At face value, these findings have substantial clinical implications. Using DCBs in provisional bifurcation stenting offers a simplified, effective approach to managing side branch compromise. By delivering localized anti-proliferative therapy without adding a permanent implant, DCBs may reduce the risk of late complications such as restenosis and myocardial infarction, which are key drivers of adverse outcomes in bifurcation interventions.

The recent FDA approval of DCBs for coronary use in the United States catapulted coronary DCBs into commercial availability here in the US, although with substantial financial cost. DCBs will likely be increasingly used in specific lesion subsets, including stent failure and small vessel disease. The present study by Gao et al. provides cautious encouragement for using DCBs to treat compromised side branches during provisional stenting over NCBs. Further studies should focus on elucidating the mechanisms of benefit and further phenotyping which lesions may alternatively benefit more from side-branch rescue with a stent versus DCB versus conservatively deferring further intervention.

References

Gao, X, Tian, N, Kan, J. et al. Drug-Coated Balloon Angioplasty of the Side Branch During Provisional Stenting: The Multicenter Randomized DCB-BIF Trial. JACC. 2025 Jan, 85 (1) 1–15. https://doi.org/10.1016/j.jacc.2024.08.067