School of Medicine and Health Sciences George Washington University Washington DC.
Department of General Surgery Cleveland Clinic Florida Weston FL.
J Am Heart Assoc. 2021 Dec 7;10(23):e022060. doi: 10.1161/JAHA.121.022060. Epub 2021 Nov 19.
Background Both drug-coated balloon (DCB) angioplasty and conventional plain balloon angioplasty (PBA) can be implemented to treat hemodialysis dysfunction. The present study aims to compare the safety and efficacy of these 2 approaches by conducting a meta-analysis of available randomized controlled trials. Methods and Results PubMed, Cochrane Library, and Embase databases were queried from establishment to January 2021. A total of 18 randomized controlled trials including 877 and 875 patients in the DCB and PBA groups, respectively, were included in the present meta-analysis. Target lesion primary patency, circuit patency, target lesion revascularization, and mortality were pooled. Odds ratios (ORs) were reported with 95% CIs. Publication bias was analyzed with funnel plot and Egger test. Target lesion primary patency was higher among patients who underwent DCB (OR, 2.93 [95% CI, 2.13-4.03], <0.001 at 6 months; OR, 2.47 [95% CI, 1.53-3.99], <0.001 at 1 year). Also, the DCB group had a higher dialysis circuit patency at 6 months (OR, 2.42; 95% CI, 1.56-3.77 [<0.001]) and 1 year (OR, 1.91; 95% CI, 1.22-3.00 [=0.005]). Compared with the PBA group, the DCB group had lower odds of target lesion revascularization during follow-up (OR, 0.43 [95% CI, 0.23-0.82], =0.001 at 6 months; OR, 0.74 [95% CI, 0.32-1.73], =0.490 at 1 year). The OR of mortality was comparable between 2 groups at 6 months (OR, 1.18; 95% CI, 0.42-3.33 [=0.760]) and 1 year (OR, 0.93; 95% CI, 0.58-1.48 [=0.750]). Conclusions Based on evidence from 18 randomized controlled trials, DCB angioplasty is superior to PBA in maintaining target lesion primary patency and circuit patency among patients with dialysis circuit stenosis. DCB angioplasty also reduces target lesion revascularization with a similar risk of mortality compared with PBA.
药物涂层球囊(DCB)血管成形术和传统的普通球囊血管成形术(PBA)均可用于治疗血液透析功能障碍。本研究旨在通过对现有随机对照试验进行荟萃分析,比较这两种方法的安全性和疗效。
从建立到 2021 年 1 月,检索了 PubMed、Cochrane 图书馆和 Embase 数据库。本荟萃分析共纳入了 18 项随机对照试验,其中 DCB 组和 PBA 组分别纳入 877 例和 875 例患者。汇总了靶病变一期通畅率、血运重建率、靶病变再血管化率和死亡率。采用 95%置信区间(CI)报告比值比(OR)。采用漏斗图和 Egger 检验分析发表偏倚。DCB 组患者靶病变一期通畅率较高(6 个月时 OR,2.93 [95%CI,2.13-4.03],<0.001;1 年时 OR,2.47 [95%CI,1.53-3.99],<0.001)。此外,DCB 组在 6 个月时(OR,2.42;95%CI,1.56-3.77 [<0.001])和 1 年时(OR,1.91;95%CI,1.22-3.00 [=0.005])的透析通路通畅率更高。与 PBA 组相比,DCB 组在随访期间靶病变血运重建的可能性较低(6 个月时 OR,0.43 [95%CI,0.23-0.82],=0.001;1 年时 OR,0.74 [95%CI,0.32-1.73],=0.490)。两组患者在 6 个月时(OR,1.18;95%CI,0.42-3.33 [=0.760])和 1 年时(OR,0.93;95%CI,0.58-1.48 [=0.750])的死亡率 OR 相似。
基于 18 项随机对照试验的证据,DCB 血管成形术在维持透析通路狭窄患者的靶病变一期通畅率和通路通畅率方面优于 PBA。DCB 血管成形术还可减少靶病变血运重建,与 PBA 相比,死亡率的风险相似。