Comparison of peripheral cutting balloon angioplasty with conventional balloon angioplasty for recurrent hemodialysis vascular access stenosis: A prospective randomized controlled trial.

Abstract

Purpose: This study aimed to compare the efficacy and safety of cutting balloon angioplasty (CBA) and conventional balloon angioplasty (control group) for recurrent vascular access stenosis in arteriovenous fistulas.

Materials and methods: This prospective, randomized single-center clinical trial included patients with hemodynamically significant recurrent vascular access stenosis of an arteriovenous fistula. The Kaplan-Meier method was used to assess primary patency, whereas the log-rank test was used to evaluate differences in patency between groups. Functional evaluations were performed using Doppler ultrasonography.

Results: Patients (n = 122) were randomly assigned to undergo CBA or conventional balloon angioplasty between December 2012 and November 2017. The clinical success rate was 100% in both groups. The anatomical success rates were 65% and 56% in the CBA and control groups, respectively. The primary patency of the target lesion was significantly better in the CBA group (33.3%) than in the control group (16.1%) at 6 months (hazard ratio, 0.50; 95% confidence interval, 0.33-0.77; p = 0.00171). The stenosis percentage decreased significantly after angioplasty in the CBA group (Δ-50.7%) compared with the control group (Δ-41.9%) (p = 0.0008). Access flow, measured using duplex Doppler ultrasonography, improved after angioplasty in both groups (300-526 ml/min in the control group and, 268-546 ml/min in the CBA group). Change in access flow (Δ + 278 ± 162) in the CBA group tended to be greater than that in the control group (Δ + 226 ± 151) (p = 0.07). However, the difference was not statistically significant.

Conclusion: In patients with recurrent vascular access stenosis of the arteriovenous fistula CBA is effective and superior to conventional angioplasty.