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

ABSTRACT 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.