药物涂层球囊与常规球囊血管成形术治疗血液透析动静脉瘘或移植物：系统评价和随机对照试验的荟萃分析。

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

机构信息

Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.

Department of Family Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.

出版信息

PLoS One. 2020 Apr 14;15(4):e0231463. doi: 10.1371/journal.pone.0231463. eCollection 2020.

BACKGROUND

Restenosis 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.

METHODS

A 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.

RESULTS

Eleven 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).

CONCLUSION

DCB 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

在血液透析血管通路的血管内治疗中，再狭窄仍然是一个重大问题。药物涂层球囊（DCB）血管成形术可降低外周和冠状动脉疾病的再狭窄率。本系统评价和荟萃分析的目的是评估与传统球囊（CB）血管成形术相比，DCB 血管成形术治疗血液透析血管通路狭窄的通畅结局。

方法

在 MEDLINE、EMBASE 和 CENTRAL 数据库中进行全面检索，以确定评估 DCB 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。主要终点是 6 个月时的靶病变主要通畅率，次要终点是 12 个月时的靶病变主要通畅率和与操作相关的并发症。汇总风险比（RR），并分别分析相关亚组。

结果

纳入了 11 项随机对照试验，共 487 例患者接受 DCB 血管成形术治疗，489 例患者接受 CB 血管成形术治疗。6 个月时的靶病变主要通畅率[RR，0.75；95%置信区间（CI），0.56，1.01；p=0.06]和 12 个月时的靶病变主要通畅率[RR，0.89；95%CI，0.79，1.00；p=0.06]无显著差异。即使在动静脉瘘亚组或不包括中心静脉狭窄的研究亚组中，DCB 组也没有获益。两组之间操作相关并发症的风险无差异（RR，1.00；95%CI，0.98，1.02；p=0.95）。