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Efficacy and Safety of Paclitaxel-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Fistulas: A Multicenter Randomized Controlled Trial

医学 血管成形术 狭窄 靶病变 再狭窄 外科 病变 血液透析 动静脉瘘 临床终点 气球 切割气球 瘘管 随机对照试验 支架 放射科 内科学 经皮冠状动脉介入治疗 心肌梗塞
作者
Yanqi Yin,Yaxue Shi,Tianlei Cui,Hua Li,Jianghua Chen,Lihong Zhang,Zhengya Yu,Hong Li,Yan Yan,Kun Wu,Qizhuang Jin
出处
期刊:American Journal of Kidney Diseases [Elsevier]
卷期号:78 (1): 19-27.e1 被引量:30
标识
DOI:10.1053/j.ajkd.2020.11.022
摘要

Previous studies have illustrated the potential superiority of drug-coated balloons (DCBs) in maintaining patency after initial angioplasty for arteriovenous fistula (AVF) dysfunction due to stenosis. Our trial evaluated the efficacy and safety of DCBs for preventing fistula restenosis in Chinese hemodialysis patients.Multicenter, prospective, randomized, open-label, blinded end point, controlled trial.A total of 161 hemodialysis patients with fistula dysfunction from 10 centers in China.Participants were randomized 1:1 to treatment with initial dilation followed by DCB angioplasty or conventional high-pressure balloon (HPB) angioplasty.The primary end point was target lesion primary patency defined as the target lesion intervention-free survival in conjunction with an ultrasonography-measured peak systolic velocity ratio (PSVR) ≤2.0 at 6 months. The secondary end points included 1) device, technical, clinical, and procedural success; 2) major adverse events; 3) degree of target lesion stenosis at 6 months; and 4) clinically driven target lesion and target shunt revascularization within 12 months.The percentage with target lesion primary patency as defined by a PSVR ≤2.0 was higher in the DCB group than in the control group (65% vs 37%, respectively; rate difference, 28% [95% CI, 13%-43%]; P <0.001) at 6 months. The target lesion and target shunt intervention-free survival of the DCB group were not superior to those of the control group at 6 months (P = 0.3 and P = 0.2, respectively) but were superior at 12 months (target lesion intervention-free survival: 73% for DCB vs 58% for control [P = 0.04]; target shunt intervention-free survival: 73% for DCB vs 57% for control [P = 0.04]). The average degree of target lesion stenoses at 6 months was not significantly different between the 2 groups (44% ± 16% for DCB vs 49% ± 18% for control; P = 0.09). There were no significant differences in major adverse events or in device, technical, clinical, or procedural success rates between the groups.Small sample size; short follow-up period; procedural differences between the 2 groups such as unequal inflation times and balloon lengths.Compared to conventional HPB angioplasty, DCB treatment achieved superior primary patency defined using PSVR measured at 6 months and superior intervention-free survival of both the target lesion and the target shunt at 12 months without evidence of greater adverse events.Funded by ZhuHai Cardionovum Medical Device Co., Ltd.Registered at ClinicalTrials.gov with study number NCT02962141.
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