One-year Clinical Outcomes from the Randomized-Controlled Arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) Trial

Abstract

Purpose: To summarize 12-month results from the randomized controlled arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial.

Methods: The WAVE trial is a prospective, multicenter study conducted across 43 international centers. In the randomized arm of the trial, patients with an arteriovenous fistula (AVF) on hemodialysis with evidence of stenosis within the peripheral venous outflow circuit were randomized 1:1 to treatment with the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE) or percutaneous transluminal angioplasty (PTA). Safety outcomes of interest at 12 months included device-related events and serious adverse events. Efficacy outcomes of interest at 12 months included target lesion primary patency (TLPP), access circuit primary patency (ACPP), and the number of re-interventions.

Results: Two hundred forty-five patients were analyzed (CIE n=122; PTA n=123). At 12 months, TLPP and ACPP were significantly higher for patients treated with the CIE vs. PTA (TLPP: 69.4% vs. 38.5%, p<0.0001; ACPP: 56.4% vs. 31.1%, p=0.0002). The mean number of re-interventions to maintain target lesion patency was significantly lower for patients treated with the CIE vs. PTA at 12 months (0.50±0.92 vs. 1.08±1.16, p<0.0001), as was the mean number of re-interventions required to maintain access circuit patency (1.08±1.63 vs. 1.70±1.93, p=0.001). Device-related events were lower for the CIE vs. PTA (2.9% vs. 9.5%, p=0.049). No significant differences were observed for the proportion of patients experiencing serious adverse events.

Conclusion: The superior performance of the CIE vs. PTA provides useful information to help physicians prolong vascular access patency for hemodialysis patients who experience stenosis in their venous outflow circuit.

Keywords: WRAPSODY® Cell-Impermeable Endoprosthesis; arteriovenous fistula; hemodialysis; percutaneous transluminal angioplasty; primary patency; re-intervention; stenosis.