A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China

Autor: 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, Yuan-Yuan Ji
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Chinese Medical Journal, Vol 133, Iss 8, Pp 899-908 (2020)
Druh dokumentu: article
ISSN: 0366-6999
2542-5641
00000000
DOI: 10.1097/CM9.0000000000000743
Popis: Abstract. 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
Databáze: Directory of Open Access Journals
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