Episode 23: REFORM Trial: Biolimus DCB for In-Stent Restenosis Outcomes
Description
The REFORM study, a randomized controlled trial, assessed the efficacy of a biolimus-coated balloon (BCB) against a paclitaxel-coated balloon (PCB) for treating in-stent restenosis (ISR). While drug-coated balloons are a proven treatment for ISR, this study aimed to determine if a BCB was non-inferior to the established PCB. The study failed to demonstrate non-inferiority of the BCB, with the PCB showing better angiographic outcomes at 6 months. Despite this, clinical outcomes at 1 year were similar between the two groups, though the study wasn't powered to detect differences. The findings suggest the specific formulation of the BCB in this trial may have limited drug transfer or retention compared to the PCB. This is an AI-assisted podcast.
United States
