Comparison of Drug-Coated Balloon versus Plain Balloon Angioplasty for the Treatment of Arteriovenous Fistula Stenosis: A systematic review and meta-analysis of randomized controlled trials.

PURPOSE: Drug-coated balloon (DCB) angioplasty is a promising therapy for arteriovenous fistula (AVF) stenosis in hemodialysis patients. However, comparative evidence on the long-term efficacy of DCB versus plain balloon angioplasty (PBA), the sources of heterogeneity, and its differential effects on various access types remains inconclusive. This meta-analysis synthesizes randomized controlled trial (RCT) data to evaluate clinical outcomes of these approaches.

MATERIALS: This meta-analysis of randomized controlled trials (RCTs) evaluated DCB versus PBA for AVF stenosis (PROSPERO CRD420250651907). We systematically searched PubMed, Embase, and Web of Science from inception to February 17, 2025, for RCTs reporting 6-month target lesion primary patency.

RESULTS

Twenty-one RCTs (n = 2,537 patients) were included. DCB significantly improved primary patency at 6 months (OR 2.43, 95% CI: 1.81-3.27; P = 0.002) and 12 months (OR 1.88, 95% CI: 1.54-2.30; P = 0.230), but the benefit attenuated at 24 months (OR 1.36, 95% CI: 1.00-1.85; P = 0.794). Complication and mortality rates were comparable between groups at all timepoints.

CONCLUSIONS

DCB angioplasty provides superior short-to-medium-term primary patency versus PBA for AVF stenosis, although this benefit diminishes with prolonged follow-up. The two modalities show comparable safety. The higher initial cost of DCB necessitates individualized treatment decisions based on patient life expectancy and lesion characteristics.