Biolimus-Coated Balloon in Small-Vessel Coronary Artery Disease: The BIO-RISE CHINA Study |
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Affiliation: | 1. General Hospital of Northern Theater Command, Shenyang, People''s Republic of China;2. Sir Run Run Shaw Hospital Affiliated With the Zhejiang University School of Medicine, Hangzhou, People''s Republic of China;3. The First Hospital of Jilin University, Changchun, People''s Republic of China;4. The Second Hospital of Jilin University;5. Shanxi Cardiovascular Hospital, Taiyuan, People''s Republic of China;6. Cangzhou Central Hospital, Cangzhou, People''s Republic of China;7. Zhongda Hospital Southeast University, Nanjing, People''s Republic of China;8. Tianjin Medical University General Hospital, Tianjin, People''s Republic of China;9. Daqing Oilfield General Hospital, Daqing, People''s Republic of China;10. Beijing Anzhen Hospital, Beijing, People''s Republic of China |
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Abstract: | 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) |
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Keywords: | biolimus drug-coated balloon small-vessel disease BCB" },{" #name" :" keyword" ," $" :{" id" :" kwrd0030" }," $$" :[{" #name" :" text" ," _" :" biolimus-coated balloon DES" },{" #name" :" keyword" ," $" :{" id" :" kwrd0040" }," $$" :[{" #name" :" text" ," _" :" drug-eluting stent(s) FAS" },{" #name" :" keyword" ," $" :{" id" :" kwrd0050" }," $$" :[{" #name" :" text" ," _" :" full analysis set LLL" },{" #name" :" keyword" ," $" :{" id" :" kwrd0060" }," $$" :[{" #name" :" text" ," _" :" late lumen loss PCB" },{" #name" :" keyword" ," $" :{" id" :" kwrd0070" }," $$" :[{" #name" :" text" ," _" :" paclitaxel-coated balloon PCI" },{" #name" :" keyword" ," $" :{" id" :" kwrd0080" }," $$" :[{" #name" :" text" ," _" :" percutaneous coronary intervention PPP" },{" #name" :" keyword" ," $" :{" id" :" kwrd0090" }," $$" :[{" #name" :" text" ," _" :" per-protocol population PTCA" },{" #name" :" keyword" ," $" :{" id" :" kwrd0100" }," $$" :[{" #name" :" text" ," _" :" percutaneous transluminal coronary angioplasty RVD" },{" #name" :" keyword" ," $" :{" id" :" kwrd0110" }," $$" :[{" #name" :" text" ," _" :" reference vessel diameter |
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