1. A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China
- Author
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Quan-Min Jing, Xin Zhao, Ya-Ling Han, Ling-Ling Gao, Yang Zheng, Zhan-Quan Li, Ping Yang, Hong-Liang Cong, Chuan-Yu Gao, Tie-Min Jiang, Hui Li, Jun-Xia Li, Dong-Mei Wang, Geng Wang, Zhan-Chun Cong, Zhong Zhang, and Yuan-Yuan Ji
- Subjects
Target lesion ,Male ,medicine.medical_specialty ,China ,Paclitaxel ,medicine.medical_treatment ,Lumen (anatomy) ,lcsh:Medicine ,Coronary Artery Disease ,Balloon ,Lesion ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Internal medicine ,Angioplasty ,Target lesion stenosis ,Medicine ,Humans ,Coronary bifurcation lesions ,Myocardial infarction ,Drug-eluting balloon ,Aged ,business.industry ,lcsh:R ,Stent ,Drug-Eluting Stents ,General Medicine ,Original Articles ,Middle Aged ,medicine.disease ,Late lumen loss ,Stenosis ,Treatment Outcome ,030220 oncology & carcinogenesis ,Cardiology ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,Female ,medicine.symptom ,business ,030217 neurology & neurosurgery - Abstract
Supplemental Digital Content is available in the text, Background Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions. Methods Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses. Results At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was –11.3% (95% confidence interval: –16.3% to –6.3%, Psuperiority
- Published
- 2020