Two-Year Real-World Outcomes of Paclitaxel-Coated Balloon Treatment for Arteriovenous Fistula Stenosis in Hemodialysis Patients

Objectives The objective of this clinical investigation is to assess the clinical performance and the safety of the drug-coated balloons, Luminor 18 or Luminor 35, in the treatment of arteriovenous fistula stenosis. Methods LUMIFAV was a retrospective, single-center, non-comparative, observational cohort study of adults (≥18 years) treated with paclitaxel-coated balloons between January 2020 and September 2022. Eligible patients had mature upper extremity arteriovenous fistulas, with de novo or recurrent stenosis successfully predilated to ≤30% residual stenosis. The primary endpoint was target lesion primary patency at 6-month follow-up; other endpoints included adverse device effects, mortality, reintervention, access circuit primary patency, and target lesion/vessel revascularization. Analyses included descriptive statistics and Kaplan-Meier estimates. Results Fifty-four patients (78% male; mean age 74 years) were enrolled in the study. Most lesions were juxta-anastomotic (63%); mean lesion length and diameter were 36.9 mm and 2.2 mm, respectively. Pre-dilation was performed in 96%, and 28% underwent post-dilatation. The target lesion primary patency rate at 6 months follow-up was achieved in 78% of patients (38/49; 95% CI [63.0%; 87.8]. No device-related adverse events occurred, and the cumulative mortality rates were 4%, 16%, and 29%, at 30 days, 12 months and 24 months post-index procedure respectively . Main causes were cardiovascular or malignancy. At 30 days, 12 months, and 24 months follow-up the target lesion primary patency rates were 100%, 51% and 26%, respectively; median time to target lesion primary patency failure was 16.2 months. Access circuit primary patency rates were 98%, 54%, 24%, and 15% at 30 days, 6, 12, and 24 months, respectively. Mean time to first reintervention was 6.8 months. Conclusions The Paclitaxel-coated balloons, Luminor 18 and Luminor 35, showed favorable safety and performance for treating arteriovenous fistulas stenosis in hemodialysis patients, supporting their role in maintaining patency without device-related complications and confirming their clinical utility for arteriovenous fistulas management, increasing the delay between re-intervention and maybe, the quality of life for this fragile population.