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

PURPOSE: To summarize 12-month results from the randomized controlled arm of the Wrapsody Arteriovenous Access Efficacy (WAVE) trial. MATERIALS AND METHODS: The WAVE trial was a prospective, multicenter study conducted across 43 international centers. In the randomized arm of the trial, patients with an arteriovenous fistula 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. Effectiveness outcomes of interest at 12 months included target lesion primary patency (TLPP), access circuit primary patency (ACPP), and the number of reinterventions. 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 than for those treated with PTA (TLPP: 70.4% vs 38.5%, P < .0001; ACPP: 56.4% vs 31.1%, P = .0002). The mean number of reinterventions to maintain target lesion patency was significantly lower for patients treated with the CIE than for those treated with PTA at 12 months (0.49 [SD ± 0.92] vs 1.08 [SD ± 1.16], P < .0001), as was the mean number of reinterventions required to maintain access circuit patency (1.08 [SD ± 1.63] vs 1.70 [SD ± 1.93], P = .001). Device-related events were lower for the CIE versus PTA (2.9% vs 9.5%, P = .049). No significant differences were observed for the proportion of patients experiencing serious adverse events. CONCLUSIONS: The superior performance of the CIE versus PTA provides useful information to help physicians prolong vascular access patency for hemodialysis patients who experience stenosis in their venous outflow circuit.