Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials

BackgroundRestenosis remains a significant problem in endovascular therapy for hemodialysis vascular access. Drug-coated balloon (DCB) angioplasty decreases restenosis in peripheral and coronary artery diseases. The aim of this systematic review and meta-analysis is to assess the patency outcomes following DCB angioplasty, as compared to conventional balloon (CB) angioplasty for the stenosis of hemodialysis vascular access.MethodsA comprehensive search in the MEDLINE, EMBASE, and CENTRAL databases was conducted in order to identify eligible randomized controlled trials evaluating DCB angioplasty for hemodialysis vascular access dysfunction. The primary endpoint was the 6-month target lesion primary patency and the secondary endpoints were 12-month target lesion primary patency and procedure-related complications. Risk ratios (RR) were pooled and relevant subgroups were analyzed separately.ResultsEleven randomized controlled trials comprised of 487 patients treated with DCB angioplasty and 489 patients treated with CB angioplasty were included. There were no significant differences in the target lesion primary patency at 6 months [RR, 0.75; 95% confidence interval (CI), 0.56, 1.01; p = 0.06] and at 12 months (RR 0.89; 95% CI, 0.79, 1.00; p = 0.06). The absence of benefit for the DCB group remained, even in the arteriovenous fistula subgroup or the subgroup of studies excluding central vein stenosis. The risk of procedure-related complication did not differ between the two groups (RR 1.00; 95% CI 0.98, 1.02; p = 0.95).ConclusionDCB angioplasty did not demonstrate significant patency benefit for the treatment of hemodialysis vascular access dysfunction. Wide variations in patency outcomes across studies were noted. Further studies focusing on specific types of access or lesions are warranted to clarify the value of DCB for hemodialysis vascular access. (PROSPERO Number CRD42019119938)背景：血液透析血管通路血管内治疗中，再狭窄（Restenosis）仍是一项亟待解决的重大临床难题。药物涂层球囊（drug-coated balloon, DCB）血管成形术可降低外周动脉疾病与冠状动脉疾病患者的再狭窄发生率。本系统评价与荟萃分析旨在对比药物涂层球囊血管成形术与传统球囊（conventional balloon, CB）血管成形术治疗血液透析血管通路狭窄后的通畅性结局。 方法：本研究全面检索MEDLINE、EMBASE及CENTRAL数据库，以筛选评估药物涂层球囊血管成形术治疗血液透析血管通路功能障碍的合格随机对照试验。本研究的主要终点为术后6个月靶病变初级通畅率，次要终点为术后12个月靶病变初级通畅率与手术相关并发症。研究合并计算风险比（risk ratio, RR），并对相关亚组进行单独分析。 结果：本研究共纳入11项随机对照试验，涉及487例接受药物涂层球囊血管成形术治疗的患者与489例接受传统球囊血管成形术治疗的患者。术后6个月靶病变初级通畅率无显著组间差异[风险比（RR）=0.75；95%置信区间（CI）：0.56~1.01；P=0.06]，术后12个月靶病变初级通畅率亦无显著组间差异（RR=0.89；95%CI：0.79~1.00；P=0.06）。即使在动静脉瘘亚组或排除中心静脉狭窄研究的亚组中，药物涂层球囊组仍未显示出获益优势。两组手术相关并发症风险无显著差异（RR=1.00；95%CI：0.98~1.02；P=0.95）。 结论：药物涂层球囊血管成形术在治疗血液透析血管通路功能障碍方面未表现出显著的通畅性获益优势。现有研究间的通畅性结局差异较大。未来需开展针对特定类型血管通路或病变的研究，以明确药物涂层球囊在血液透析血管通路治疗中的应用价值。本研究PROSPERO注册号为CRD42019119938。