Drug-Coated Balloon for Arteriovenous Access Stenosis in Hemodialysis Patients

Abstract

Hemodialysis access stenosis is a pervasive problem that occurs due to the physiology of the high-flow circuit. Stenosis occurs due to endothelial and smooth muscle injuries that result in neointimal hyperplasia. Percutaneous transluminal angioplasty is the standard treatment for dialysis access-induced stenosis. Unfortunately, it is also associated with vessel wall trauma, which causes further intimal hyperplasia and restenosis. Data from randomized controlled trials (RCTs) and systematic reviews of the use of drug-coated balloons (DCBs) for dialysis access stenosis have been controversial. While several single-center trials or RCTs have reported safe and effective use of DCBs, conflicting results still exist. Furthermore, paclitaxel is known to be associated with an increased mortality risk. Herein, we review the current evidence on the role of DCBs in the treatment of dialysis access stenosis.

Ranger™ paclitaxel-coated balloon versus conventional balloon angioplasty for treatment of failing arteriovenous fistulas and grafts in haemodialysis patients: A retrospective cohort study

“…As summarised by Kim, the disparities between the meta-analyses could be due to the inclusion of larger scale multicentre studies, 6,18,19 along with heterogeneity between the types of studies and their use of multiple PCBs of differing doses and type of excipient for the PCB. 7 Time-to-event analyses from our study also reveals a trend where superior PCB patency wears off and converges with their POBA-counterpart at approximately 9-10 months post-target procedure. This was observed in circuit access patency, overall TLPP and subgroups TLPP (denovo/recurrent, JAS/non-JAS) treatment group comparisons (Figures 1(b)-(c), 2(a)-(d)).…”

“…As summarised by Kim, the disparities between the meta-analyses could be due to the inclusion of larger scale multicentre studies, 6,18,19 along with heterogeneity between the types of studies and their use of multiple PCBs of differing doses and type of excipient for the PCB. 7…”

“…4 Endovascular options include treatment with conventional balloon angioplasty (POBA), which has a 6-months target lesion primary (TLPP) patency of 55%-60%, and a TLPP of 30%-40% at 12-months. [5][6][7] Neointimal hyperplasia (NIH), characterised by rapid smooth muscle proliferation, from vessel wall barotrauma and inflammation following angioplasty has been found to be a leading cause of restenosis and vascular access dysfunction. 8 To mitigate the effects of NIH post-fistuloplasty, drug-coated balloons (DCB) such as sirolimus-and paclitaxel-coated balloons (PCBs) have emerged as alternatives to POBA, providing anti-proliferative properties, showing promising 6-months TLPP rates (TLPP; Sirolimus 58%, Paclitaxel 67%).…”