Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial

作者：Yundai Chen, Lei Gao, Qin Qin, Jun Zhang, Shaobin Jia, Mingxing Wu, Yong He, Guosheng Fu, Jinghua Liu, Hui Chen, Qian Tong, Zaixin Yu, Jian An, Chunguang Qiu, Biao Xu, Yu Cao, Changqian Wang, Genshan Ma · 发表于：EuroIntervention · 年份：2024 · DOI：10.4244/eij-d-24-00295 · 被引用次数：24 · 研究领域：Coronary Interventions and Diagnostics、Cardiac Imaging and Diagnostics、Angiogenesis and VEGF in Cancer

BACKGROUND: The treatment of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains challenging in current clinical practice. AIMS: The study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB). METHODS: This was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients. RESULTS: ; p=non-significant. CONCLUSIONS: This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov: NCT04733443).