Comparison of Clinical Effectiveness of Drug-Coated Balloons versus Percutaneous Transluminal Angioplasty in Arteriovenous Fistulae Maturation Failure: A Multicenter Prospective Study

PURPOSE: To evaluate arteriovenous fistula maturation and 12-month patency in patients undergoing oversized balloon angioplasty with high-pressure balloons alone or with high-pressure balloons plus drug-coated balloons as part of endovascular treatment for arteriovenous fistula maturation failure. MATERIAL AND METHODS: This prospective, non-randomized study was conducted between 2022 and 2024 at four centers in Brazil. Patients with primary arteriovenous fistula failure underwent oversized balloon angioplasty with high-pressure balloons alone or with high-pressure balloons + drug-coated balloons. Vascular access primary and secondary patency rates were evaluated at 3, 6, and 12 months in 198 patients. The safety endpoint was the incidence of procedure-related complications. Exploratory analyses included the impact of demographic and clinical variables on primary patency rates. RESULTS: Technical success was achieved in 99% of patients (196/198). At 12 months, vascular access primary patency was 57.8% for high-pressure balloons + drug-coated balloons vs. 41.3% for high-pressure balloons alone (p = 0.011). Twelve-month vascular access secondary patency rates were similar between groups (88.5% for high-pressure balloons + drug-coated balloons vs. 87.0% for high-pressure balloons alone, p = 0.69). Cox regression analysis identified oversized balloon angioplasty with drug-coated balloons and male sex as protective factors, reducing the 12 month risk of primary patency loss. In contrast, brachiocephalic arteriovenous fistulas and initial thrombosis were associated with an increased risk of patency loss. CONCLUSION: Oversized balloon angioplasty with drug-coated balloons improved primary patency compared to high-pressure balloons alone.