Comparative study between drug-coated balloon angioplasty vs plain balloon angioplasty in management of venous stenosis in hemodialysis access circuit

Introduction
Juxta-anastomotic venous stenosis is a major concern associated with arteriovenous fistulas, which is mainly a result of neointimal hyperplasia. Although balloon angioplasty remains the cornerstone treatment for vascular access stenosis, the combination of venous anatomy and physiology, with the pre-existing endothelial dysfunction of uremic patients, generally leads to poor mid-term and long-term results. Theoretically, vascular access patency may be optimized by a technology that would both block negative vessel wall remodeling and inhibit fibromuscular hyperplasia. One such approach could be the use of angioplasty with drug-coated balloon (DCB) angioplasty.
Patients and methods
Within a 10-month period, 80 patients with different types of hemodialysis access stenosis in whom percutaneous transluminal angioplasty (PTA) was indicated were prosTectively, randomized to have either DCB or plain balloon angioplasty (PBA). This study was designed to compare primary patency rates and target lesion revascularization of DCB vs PBA to preserve the patency of the vascular access circuit in patients undergoing hemodialysis after 1 year of follow-up.
Results
All patients enrolled in the study completed the 1-year follow-up period. Access circuit primary patency results were also significantly in favor of DCB angioplasty (DCB, 287 days, and PBA, 156 days; =0.04). Target lesion revascularization-free survival was significantly superior in the DCB group according to the Kaplan–Meier survival analysis curve (DCB, 316 days, and PBA, 172 days; =0.041). There was no statistically significant difference in this subgroup analysis (>0.1).
Conclusion
In this two-center study, DCB angioplasty results in improved vessel patency and is superior to plain balloon dilation in the treatment of venous stenoses of failing native or prosthetic arteriovenous shunts used for dialysis access.