A Randomized Prospective Study Comparing Outcomes of Angioplasty versus VIABAHN Stent-Graft Placement for Cephalic Arch Stenosis in Dysfunctional Hemodialysis Accesses.

Purpose: To determine if postintervention cephalic arch stenosis (CAS) primary patency and access circuit patency are superior with the VIABAHN stent graft compared with angioplasty at 3, 6, and 12 months.

Materials And Methods: All patients presenting with dysfunctional hemodialysis accesses with CAS over a 4-year period were assessed for inclusion in a randomized prospective study. A total of 14 patients were recruited across three centers. All patients had mature brachiocephalic fistulae. Five were randomized to undergo percutaneous transluminal angioplasty and nine to undergo stent-graft placement. Patency of the treated cephalic arch was assessed with transonic flow and/or follow-up fistulography. Variables assessed were diabetes, previous interventions performed on the access, access age and side, and sex. Patency was determined with Kaplan-Meier estimation.

Results: Anatomic and clinical success was obtained in all interventions. Mean patency intervals were 100 days in the PTA group and 300 days in the stent-graft group. Primary access circuit patency rates at 3, 6, and 12 months were significantly different: 20%, 0%, and 0% for PTA and 100%, 67%, and 22% for stent grafts (P < .01). Primacy target lesion patency rates at 3, 6, and 12 months were also significantly different: 60%, 0%, and 0% for PTA and 100%, 100%, and 29% for stent grafts (P < .01). No complications or adverse events were observed.

Conclusions: Treatment of CAS with the VIABAHN stent graft appears to provide statistically superior primary patency rates compared with balloon angioplasty.