To evaluate the efficacy and safety of paclitaxel-coated balloon angioplasty in the treatment of thrombosed arteriovenous fistulas. This prospective, randomized, controlled study investigated the use of drug-eluting balloons in the treatment of the thrombosis of arteriovenous fistulas (AVFs) at our center between January 2018 and January 2023. A total of 246 patients were included in the study. The mean age of the patients was 61.3 ± 11.5 years. Of the patients, 150 (61%) were male and 96 (39%) were female. Angioplasty was performed using a plain balloon (PB) in 126 patients (51.2%) and a drug-coated balloon (DCB) in 120 (48.8%). The control images of the patients were obtained at the sixth and 12th months. Patency was evaluated during the follow-up. There was no significant difference between the two groups in terms of age, gender, hypertension, hyperlipidemia, diabetes, fistula location, or stenosis length. No significant difference was observed between the groups regarding the number of complications observed during and after the procedure. At the end of the sixth month, the patency rate was found to be 86.7% in the DCB group and 78.6% in the PB group. The 12th-month patency rate was 77.5% in the DCB group and 57.9% in the PB group. A significant difference was detected between the two groups in relation to the 6th- and 12th-month patency rates (p = 0.034 and p = 0.046, respectively). Drug-coated balloon angioplasty is an effective approach to the treatment of thrombosed AVFs, especially in terms of prolonging primary patency and reducing the need for secondary procedures.
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