Paclitaxel Coated Balloons for Haemodialysis Vascular Access Stenosis: A Systematic Review and Meta-analysis of Randomised Controlled Trials

Abstract

Objective: Paclitaxel coated balloons have been used to prevent recurrent stenosis in haemodialysis vascular access. Despite the availability of many randomised controlled trials (RCTs), its effectiveness compared with plain balloon angioplasty remains inconclusive. This systematic review and meta-analysis aimed to clarify the effectiveness of paclitaxel coated balloons compared with plain balloon angioplasty for vascular access stenosis based on available randomized controlled trials.

Data sources: Embase.com and Ovid/Medline.

Review methods: A systematic literature search was performed in Embase.com and Ovid Medline on 02 September 2025 to identify RCTs comparing paclitaxel coated balloons with plain balloons for vascular access stenosis. The primary endpoint was loss of primary patency at 12 months. Risk of bias was assessed with the Cochrane risk of bias tool for randomised trials (RoB 2) and certainty of evidence was assessed with GRADE. The summary treatment effect was estimated by meta-analysis using random effects models with an inverse variance approach based on odds ratios. The meta-analysis was registered with PROSPERO (CRD42024502432) and conducted without external funding.

Results: The literature search identified 26 RCTs with 2 930 patients. The overall risk of bias was low in five studies, intermediate in 19 studies, and high in two studies. The odds ratio of primary patency loss after 12 months was 0.54 (95% confidence interval [CI] 0.44 - 0.66; p < .001) in favour of paclitaxel coated balloons, with little between study heterogeneity (I² 10%). This resulted in a number needed to treat of seven (95% CI 5 - 10) paclitaxel coated balloon angioplasties to prevent one access related re-intervention. Sensitivity analyses found no impact of variations in study design, risk of bias, or the time point of analysis on the treatment effect of paclitaxel coated balloons. In subgroup analyses, the treatment effect was not significantly different between arteriovenous fistulas and grafts, new and recurrent stenosis, or paclitaxel coated balloon type. The certainty of evidence was high for loss of primary patency and low for vascular access thrombosis and abandonment.

Conclusion: Paclitaxel coated balloon angioplasty for vascular access stenosis reduces the odds of re-intervention at 1 year compared with plain balloon angioplasty. This meta-analysis provides high certainty evidence to support a strong recommendation to use paclitaxel coated balloons when treating vascular access stenosis.

Keywords: Arteriovenous fistula; Balloon angioplasty; Drug coated; Haemodialysis vascular access; Paclitaxel.