Objective

A systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to determine the effectiveness and safety of drug coated balloon (DCB) angioplasty compared with uncoated plain balloon (PB) angioplasty in treating arteriovenous access stenosis.

Methods

MEDLINE, Embase, Scopus, and the Cochrane Central Register of Controlled Trials were searched for RCTs comparing paclitaxel coated DCB and PB angioplasty for arteriovenous access stenosis. The last date of the literature search was 31 December 2020. Risk of bias of the retrieved studies was assessed with the Cochrane Collaboration tool for assessing risk of bias (RoB 2.0). The random effects model was used to estimate the risk of loss of target lesion patency (six and 12 months) and circuit patency (six and 12 months). Procedure related adverse events and mortality rate were also compared. Patency results were pooled using the time to event meta-analytical method and the quality of evidence was assessed according to the GRADE approach.

Results

Sixteen eligible trials, including 1 682 lesions, were included in the quantitative analysis for the efficacy and safety of paclitaxel coated DCBs. DCBs were associated with a lower risk of loss of target lesion patency at six months (HR 0.53, 95% CI 0.42 – 0.66) and 12 months (HR 0.60, 95% CI 0.47 – 0.76), and were also associated with improved six and 12 month circuit patency. Overall quality of evidence was moderate to low. Procedural complications were rare, and the risk of death up to 12 months was similar between the two groups (OR 1.03, 95% CI 0.68 – 1.56).

Conclusion

Paclitaxel coated DCBs reduced the risk of loss of target lesion patency and circuit patency in arteriovenous access stenosis compared with PBs. Considering the heterogeneity of the included trials, there is a need to investigate optimal treatment regimens regarding drug dose and agent of the DCB and the treatment procedure.

中文翻译：

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编辑推荐——紫杉醇涂层球囊血管成形术与用于血液透析动静脉通路狭窄的普通球囊血管成形术：随机对照试验的系统评价和事件发生时间荟萃分析

客观的

对随机对照试验 (RCT) 进行了系统评价和荟萃分析，以确定药物涂层球囊 (DCB) 血管成形术与未涂层球囊 (PB) 血管成形术相比治疗动静脉通路狭窄的有效性和安全性。

方法

MEDLINE、Embase、Scopus 和 Cochrane Central Register of Controlled Trials 搜索了比较紫杉醇涂层 DCB 和 PB 血管成形术治疗动静脉通路狭窄的 RCT。文献检索的最后日期是 2020 年 12 月 31 日。使用 Cochrane Collaboration 评估偏倚风险的工具 (RoB 2.0) 评估了检索到的研究的偏倚风险。随机效应模型用于估计失去目标病灶通畅（6 个月和 12 个月）和回路通畅（6 个月和 12 个月）的风险。还比较了手术相关的不良事件和死亡率。通畅性结果使用事件发生时间元分析方法汇总，并根据 GRADE 方法评估证据质量。

结果

16 项符合条件的试验，包括 1 682 个病灶，被纳入紫杉醇涂层 DCB 有效性和安全性的定量分析。DCB 与在 6 个月（HR 0.53，95% CI 0.42 – 0.66）和 12 个月（HR 0.60，95% CI 0.47 – 0.76）时失去目标病灶通畅的风险较低，并且还与改善的 6 和12 个月的电路通畅。证据的总体质量为中到低。手术并发症很少见，两组之间长达 12 个月的死亡风险相似（OR 1.03，95% CI 0.68 – 1.56）。

结论

与 PBs 相比，紫杉醇涂层 DCBs 降低了动静脉通路狭窄中靶病变通畅性和回路通畅性丧失的风险。考虑到纳入试验的异质性，有必要研究DCB的药物剂量和药剂以及治疗程序的最佳治疗方案。