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

Background: This study aims to evaluate the efficacy and safety of paclitaxel-coated balloons (Acoart Orchid) in treating dysfunctional arteriovenous fistulae. Methods: The drug-eluting balloon for arteriovenous 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 pre-dilation 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 done 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 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 endpoint was primary target lesion patency at 12 months, which was 66% (74/112) for the drug-coated balloon 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 in order to maintain target lesion patency during the 12 months after the index procedure was 0.39 (48/122) in the drug-coated balloon group and 0.77(94/122) in the plain balloon catheter group (P=0.001). The primary safety endpoint did not differ between groups (P=0.25). Conclusions: AcoArt Orchid drug-coated balloon showed better primary patency rates compared with plain balloon angioplasty for treating stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas at 6 months and 12 months. It required fewer repeated interventions and had comparable safety in one year.