Original Research

DOI: 10.4244/EIJ-D-24-00295

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

Yundai Chen1, MD; Lei Gao2, MD; Qin Qin3, MD; Jun Zhang4, MD; Shaobin Jia5, MD; Mingxing Wu6, MD; Yong He7, MD; Guosheng Fu8, MD; Jinghua Liu9, MD; Hui Chen10, MD; Qian Tong11, MD; Zaixin Yu12, MD; Jian An13, MD; Chunguang Qiu14, MD; Biao Xu15, MD; Yu Cao16, MD; Changqian Wang17, MD; Genshan Ma18, MD

Abstract

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: A total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was −0.02 (95% confidence interval [CI]: −0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm2 in the BCB group compared to 2.37±0.93 mm2 in the PCB group; the mean difference between the groups was −0.09 (95% CI: −0.94 to 0.76) mm2; 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)

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Volume 20 Number 13
Jul 1, 2024
Volume 20 Number 13
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