Drug‐Coated Balloon Versus Plain Balloon Angioplasty for Hemodialysis Dysfunction: A Meta‐Analysis of Randomized Controlled Trials

Abstract

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], P <0.001 at 6 months; OR, 2.47 [95% CI, 1.53–3.99], P <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 [ P <0.001]) and 1 year (OR, 1.91; 95% CI, 1.22–3.00 [ P =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], P =0.001 at 6 months; OR, 0.74 [95% CI, 0.32–1.73], P =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 [ P =0.760]) and 1 year (OR, 0.93; 95% CI, 0.58–1.48 [ P =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.

Comparative efficacy of five balloons for treating autogenous arteriovenous fistula stenosis: a Bayesian network meta-analysis

“…Four studies investigating the effect of DEB (21)(22)(23)(24) and nine studies investigating the effect of DCB were included in our NMA (12,(15)(16)(17)(18)(19)(20)(21)29). The results demonstrated that both DEB and DCB had a statistically higher patency rate compared with PBA at all time points, which was consistent with the results of several recently published studies (40,41). Meanwhile, both these studies demonstrated that the use of DCB did not cause a significant increase in patient mortality, indicating the high safety of DCB compared with PBA.…”

Study protocol for a Prospective, Randomized controlled trial of stEnt graft and Drug-coated bAlloon Treatment for cephalic arch stenOsis in dysfunctional arteRio-venous fistulas (PREDATOR)

“…The treatment of PCB in both arms is to ensure all patients receive ethical standard of care treatment while testing the research hypothesis since PCB can now be considered standard of care, especially for AVF with recurrent stenosis. 20 TLPP and ACPP are chosen as the primary endpoints because the study is designed to treat all stenosis in the AVF circuit in addition to CAS. Furthermore, it is the ACPP that is clinically meaningful for the patients.…”

Choosing the right treatment for the right lesion, Part II: a narrative review of drug-coated balloon angioplasty and its evolving role in dialysis access maintenance

“…Given the lack of clarity provided by the available RCTs, numerous systematic reviews and meta-analyses have been performed over the years. However, these have also been unable to provide a clearer sense of the effectiveness of DCB us in AV access, noting conflicting conclusions likely related to differences in the meta-analyses, including their unique inclusion criteria, availability of RCTs and other studies for inclusion based on time of publication, and different analytic methods (14,66,76,(103)(104)(105)(106)(107).…”

“…A 2021 meta-analysis by Fong et al included 12 RCTs and employed numerous types of analyses, with the majority suggesting a benefit associated with DCB use ( 105 ). Similarly, a 2021 meta-analysis by Liu et al included 18 RCTs and suggested DCBs improved TLPP and ACPP compared to POBA ( 106 ). However, this was followed by a 2022 meta-analysis by Luo et al including 14 RCTs which demonstrated no clear advantage of DCBs compared to POBA ( 73 ).…”