Biolimus-Coated Balloon in Small-Vessel Coronary Artery Disease: The BIO-RISE CHINA Study

• Published in: JACC. Cardiovascular interventions 2022-06, Vol.15 (12), p.1219-1226
• Main Authors: Xu, Kai, Fu, GuoSheng, Tong, Qian, Liu, Bin, Han, XueBin, Zhang, Jun, Ma, GenShan, Yang, Qing, Li, Hui, Zhou, Yujie, Jing, Quanmin, Li, Yi, Han, YaLing
• Format: Article
• Language: English
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2022.03.024

BACKGROUNDDrug-coated balloons are a safe and effective option for patients undergoing percutaneous coronary intervention, but prior randomized studies have exclusively used paclitaxel-coated devices. OBJECTIVESThe aim of this study was to assess for the first time the safety and efficacy of a novel biolimus-coated balloon (BCB) in patients with small-vessel coronary disease. METHODSIn a prospective trial conducted at 10 centers in China, 212 patients with small-vessel native coronary disease (reference vessel diameter 2.0-2.75 mm, lesion length ≤25 mm) were randomized to receive a BCB or an uncoated balloon. The primary endpoint was in-segment late lumen loss at 9 months. RESULTSIn the per-protocol population, angiographic late lumen loss at 9 months was 0.16 ± 0.29 mm in the BCB group vs 0.30 ± 0.35 mm with the plain balloon (P = 0.001). Late luminal enlargement (positive remodeling) occurred in 29.7% of patients in the BCB group vs 9.8% of patients with plain balloons (P = 0.007). In the full analysis set population, after 12 months, target lesion failure rates were 6.7% in the BCB group vs 13.9% with the plain balloon (HR: 0.47; 95% CI: 0.19-1.16), and rates of the patient-oriented clinical outcome were 14.3% with the BCB vs 21.8% with the plain balloon (HR: 0.64; 95% CI: 0.33-1.24). CONCLUSIONSIn this first-in-human study, a novel BCB showed superior efficacy to plain balloon angioplasty in patients with small-vessel coronary disease undergoing percutaneous coronary intervention. Positive vascular remodeling was more frequent, and there was a trend toward improved clinical outcomes. (A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery Disease [Brave]; NCT03769623).