A Novel Propyl Gallate‐Based Paclitaxel‐Coated Balloon for the Side Branch Treatment in Coronary Bifurcation Lesions

BACKGROUND: Drug-coated balloons are emerging as an important approach for the treatment of coronary bifurcation lesions (CBL). AIMS: This study aimed to evaluate the efficacy and safety of a novel paclitaxel-coated balloon (PCB), which used propyl gallate (PG) as the excipient, in treating the side branch of de novo CBL. METHODS: In this multicenter, randomized, non-inferiority trial, 236 patients across 17 centers were 1:1 randomized to the PG-based PCB or iohexol-based PCB groups. After stent deployment in the main vessel, the side branch was dilated with the allocated PCB. Angiographic follow-up was planned at 9 months and clinical follow-up at 12 months. The primary endpoint was diameter stenosis (DS) in the side branch during the angiographic follow-up. RESULTS: DS in the side branch was 21.3 ± 23.8% in the PG group versus 21.7 ± 24.3% in the control group (p = 0.198). After adjustment for centers, the difference of DS between the PG group and the control group was -0.11% (95% confidence interval, -6.84% to 6.62%), meeting the prespecified non-inferiority margin of 7%. Clinical outcomes at 12 months were comparable between groups. CONCLUSIONS: The PG-based PCB demonstrated non-inferior efficacy and safety in comparison with the iohexol-based PCB for side branch treatment in de novo CBL. The PG-based PCB could be used as a therapeutic alternative in CBL revascularization.