Efficacy and safety of paclitaxel drug-coated balloon angioplasty for stenosis of hemodialysis vascular access: 6-month results from a brazilian multicenter prospective study.

Background: Stenosis resulting from neointimal hyperplasia remains a significant concern associated with dysfunction of arteriovenous fistulas (AVF).

Objectives: To investigate the safety and efficacy of paclitaxel drug-coated balloon (DCB) angioplasty for treating failing AVFs.

Methods: Investigators analyzed 58 hemodialysis patients treated with Ranger^TM DCBs from December 2022 to December 2023 across four centers. Lesions treated were de novo or restenotic and located in the juxta-anastomosis, cannulation zone, and outflow segment. Patients were evaluated through physical examinations and Duplex ultrasound at 1, 3, and 6 months. The primary efficacy endpoint was target lesion primary patency at 1, 3, and 6 months, and the primary safety endpoint was freedom from serious adverse events through 30 days post-procedure. Secondary endpoints were access circuit primary patency and technical and procedural success.

Results: Nine patients (16%) had thrombosed access at the initial presentation, and 31 (53%) presented with recurrent stenosis. The target lesion primary patency rate at 6 months was 85.7%, and the access circuit primary patency rate at 6 months was 67.5%. No serious adverse events, either local or systemic, were reported. Sex, age, stenosis location, type of lesion, presence of thrombosis, lesion recurrence, diabetes status, or whether post-ballooning dilation was performed did not significantly affect the 6-month target lesion primary patency.

Conclusions: DCB angioplasty was shown to be safe and effective for treating peripheral stenosis in vascular access.