The purpose of a new study published in PLoS One was to evaluate the safety and efficacy of a sirolimus-coated balloon (SCB) catheter on improving the patency of failing arterio-venous fistulas (AVF) with de novo and recurrent stenoses.

This was a single-center, single-arm prospective pilot study that included 33 – 18 males; mean age 64.7±11.6 years, end-stage renal failure Asian patients – with a dysfunctional AVF, who underwent SCB angioplasty between May 2019-January 2020. All procedures were performed under local anesthetic without sedation and as day surgery. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 3 and 6 months.

Overall, 47 stenotic target lesions were treated and 72.7% patients were for restenosis. Main indications for intervention was low/dropping access flow in 63.6% and the most common target lesion was in the juxta-anastomosis 40.4%. There was 100% technical and procedural success with no peri-procedural complications related to the SCB. The target lesion primary patency rates at 3 and 6 months were 97.9% and 82.9%, respectively. Circuit access patency rates at 3 and 6 months were 93.9% and 68%, respectively. There was one death at 6 months and 12.1% overall mortalities till date, all from patients underlying co-morbidities.

From the results, it was concluded that SCB angioplasty for dysfunctional AVF circuits is a safe and efficacious modality in Asian hemodialysis patients at six months, comparable if not better than the paclitaxel data reported to date in the literature.

Source: PLoS One. 2020 Oct 27;15(10):e0241321. doi: 10.1371/journal.pone.0241321.