Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.
Department of Vascular Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Am J Kidney Dis. 2021 Jul;78(1):19-27.e1. doi: 10.1053/j.ajkd.2020.11.022. Epub 2021 Jan 5.
RATIONALE & OBJECTIVE: 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.
SETTINGS & PARTICIPANTS: 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.
先前的研究表明，在因狭窄而导致动静脉瘘（AVF）功能障碍的初始血管成形术后，药物涂层球囊（DCB）在维持通畅方面具有潜在优势。我们的试验评估了 DCB 预防中国血液透析患者动静脉内瘘再狭窄的疗效和安全性。
多中心、前瞻性、随机、开放标签、盲终点、对照试验。
共有来自中国 10 个中心的 161 名血液透析患者存在瘘功能障碍。
参与者按照 1:1 随机分为初次扩张后行 DCB 血管成形术或常规高压球囊（HPB）血管成形术的治疗组。
主要终点是目标病变一期通畅率，定义为 6 个月时超声测量的峰值收缩速度比（PSVR）≤2.0的目标病变无干预生存率。次要终点包括 1）设备、技术、临床和程序成功；2）主要不良事件；3）6 个月时目标病变狭窄程度；以及 4）12 个月内的临床驱动的目标病变和目标分流再血管化。
6 个月时，PSVR≤2.0 的目标病变一期通畅率在 DCB 组高于对照组（分别为 65%和 37%；差异率为 28%[95%CI，13%-43%]；P<0.001）。6 个月时，DCB 组的目标病变和目标分流无干预生存率并不优于对照组（P=0.3 和 P=0.2），但 12 个月时优于对照组（目标病变无干预生存率：DCB 组为 73%，对照组为 58%[P=0.04]；目标分流无干预生存率：DCB 组为 73%，对照组为 57%[P=0.04]）。两组 6 个月时的平均目标病变狭窄程度无显著差异（DCB 组为 44%±16%，对照组为 49%±18%；P=0.09）。两组间主要不良事件或设备、技术、临床或程序成功率无显著差异。
样本量小；随访时间短；两组之间存在程序差异，如充气时间和球囊长度不等。
与常规 HPB 血管成形术相比，DCB 治疗可在 6 个月时通过 PSVR 测量实现更好的一期通畅率，并在 12 个月时实现目标病变和目标分流的无干预生存率更高，且无证据表明不良事件增加。
由珠海心诺医疗科技有限公司资助。
ClinicalTrials.gov 登记号：NCT02962141。
