Multicenter, Randomized Trial of Conventional Balloon Angioplasty versus Paclitaxel-Coated Balloon Angioplasty for the Treatment of Dysfunctioning Autologous Dialysis Fistulae

Abstract Purpose To investigate the potential added value of paclitaxel-coated balloon (PCB) angioplasty to reduce fistula dysfunction related to recurrent stenoses in patients undergoing hemodialysis. Materials and Methods A prospective, randomized study was conducted in 3 dialysis referral centers. From January 2013 to October 2015, 64 patients (22 female, 42 male) with dysfunctional autologous dialysis fistulae were randomized to undergo conventional percutaneous balloon angioplasty (n = 31) or PCB angioplasty (n = 33). Procedural and postprocedural data were assessed. Primary patency of the fistula was evaluated at 3, 6, and 12 months following the procedure. Statistical analysis was based on the Fisher exact test and independent t test. Results There were no procedural or postprocedural complications. After 3, 6, and 12 months of follow-up, primary patency rates after PCB angioplasty and percutaneous transluminal angioplasty (PTA) were 88% and 80% ( P  = .43), 67% and 65% ( P  = .76), and 42% and 39% ( P  = .95), respectively. Conclusions Although primary patency rates after PCB angioplasty in autologous dialysis fistulae at 3, 6, and 12 months of follow-up are slightly better than those after PTA, the difference is not statistically significant.