An observational study assessing the use of Sirolimus-eluting balloons for side-branch treatment in the provisional...

Area of Science:

• Interventional Cardiology
• Vascular Medicine
• Drug Delivery Systems

Background:

• Drug-eluting balloons (DEB) are established for treating in-stent restenosis and small vessel disease.
• Limited data exists on DEB efficacy in complex coronary artery bifurcation lesions.

Purpose of the Study:

• To evaluate the effectiveness of provisional upfront side-branch DEB use in bifurcation lesions.
• To compare DEB treatment against plain old balloon angioplasty (POBA) and a two-stent strategy.

Main Methods:

• Observational study of 625 patients undergoing percutaneous coronary intervention (PCI) for bifurcation lesions.
• All patients received a drug-eluting stent (DES) in the main vessel; side branch treatment varied.
• Primary endpoint was target vessel failure (TVF); secondary endpoints included TV myocardial infarction and all-cause mortality.

Main Results:

• 311 patients received upfront DEB for the side branch, 188 received a second DES, and 126 underwent POBA.
• Target vessel failure occurred less frequently in the DEB (3.3%) and DES (3.3%) groups compared to POBA (7.5%).
• No significant differences were observed in target vessel myocardial infarction or all-cause mortality between groups.

Conclusions:

• Provisional side-branch stenting with upfront Sirolimus DEB is effective for non-left main bifurcation PCI.
• DEB treatment demonstrates a favorable safety profile in bifurcation lesions.
• DEB offers a promising alternative to repeat stenting or POBA in specific bifurcation scenarios.