Hemodialysis Arteriovenous Fistula and Graft Stenoses: Randomized Trial Comparing Drug-eluting Balloon Angioplasty with Conventional Angioplasty

Purpose: To compare lesion primary patency and restenosis rates between drug-eluting balloon (DEB) percutaneous transluminal angioplasty (PTA) and conventional balloon PTA (cPTA) in the treatment of arteriovenous fistula (AVF) and arteriovenous graft (AVG) stenosis. Materials and Methods: In this prospective study, 119 participants (mean age, 59.2 years; 79 men, 40 women) with failing AVFs (n=98) or AVGs (n=21) were randomly assigned to undergo either DEB PTA (n=59) or cPTA (n=60) from January 2012 to May 2013. Primary end points were lesion primary patency and restenosis rates at 6 months; secondary outcomes were anatomic and clinical success after PTA, circuit primary patency at 6 months and 1 year, and lesion primary patency at 1 year. Statistical analysis was performed by using the Kaplan-Meier product limit estimator, and hazard ratio was calculated by using Cox proportional hazards regression. Complication rates were assessed in both groups. Results: Estimated lesion primary patency in the DEB PTA and cPTA arms was 0.81 and 0.61, respectively, at 6 months (P=.03) and 0.51 and 0.34, respectively, at 1 year (P=.04). Estimated circuit primary patency in the DEB PTA and cPTA arms was 0.76 and 0.56, respectively, at 6 months (P=.048) and 0.45 and 0.32, respectively, at 1 year (P=.16). Restenosis rate was 34.0% (16 of 47) for DEB PTA and 62.9% (22 of 35) for cPTA at 6 months (P=.01). No major complications were noted. Conclusion: Drug-eluting balloon angioplasty was effective in prolonging lesion primary patency of dialysis access stenoses at 6 months and 1 year. (c) RSNA, 2018