Drug-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Hemodialysis Fistulae: A Randomized Controlled Trial

Abstract

Background: The aim of this study was to evaluate the efficacy and safety of paclitaxel-coated balloons (AcoArt Orchid) in treating dysfunctional arteriovenous fistulae.

Methods: The drug-eluting balloon for arteriovenous (AV) fistula in China trial was a prospective, multicenter, randomized controlled study. Patients who had ≥50% venous stenosis of the AV fistula and symptoms indicating significant hemodynamic changes were included. After successful predilation with a high-pressure balloon (residual stenosis ≤30%), patients were randomized 1:1 to either a paclitaxel-coated balloon or an uncoated control balloon. The primary efficacy outcome was assessed at 6 months, and safety assessment was conducted within 30 days of the procedure. The 12-month results were also analyzed.

Results: The study included 244 patients, equally distributed between the two groups. The primary target lesion patency was 91% (106/116) for the drug-coated balloon (DCB) group and 67% (79/118) for the plain balloon catheter group, representing a difference of 24.63% (95% confidence interval, 14.68 to 34.58; P < 0.001). The secondary efficacy end point was primary target lesion patency at 12 months, which was 66% (74/112) for the DCB group and 46% (52/112) for the plain balloon catheter group (95% confidence interval, 6.57 to 32.08; P = 0.004). The mean number of reinterventions per patient to maintain target lesion patency during the 12 months after the index procedure was 0.39 (48/122) in the DCB group and 0.77 (94/122) in the plain balloon catheter group ( P = 0.001). The primary safety end point did not differ between groups ( P = 0.25).

Conclusions: AcoArt Orchid DCB showed better primary patency rates compared with plain balloon angioplasty for treating stenotic lesions in dysfunctional hemodialysis AV fistulae at 6 and 12 months. It required fewer repeated interventions and had comparable safety in 1 year.

Clinical trial registry name and registration number: AcoArt III/Arterio-venous Fistula in China, NCT03366727 .