89.8%
6-Month
Target Lesion
Primary Patency
Positive 6-month findings from the randomized arteriovenous (AV) fistula arm of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial were shown at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) during a FIRST@CIRSE presentation.
The AV fistula arm of the WAVE trial enrolled 245 patients at 43 sites. Patients were randomized 1:1 to WRAPSODY or percutaneous transluminal angioplasty (PTA).
Target lesion primary patency in patients treated with WRAPSODY was 27 percentage points higher than patients in the PTA cohort (89.8% vs. 62.8%, p<0.0001).1 The proportion of patients who experienced an adverse event was similar between cohorts.2
1. The primary efficacy endpoint was defined as the freedom from clinically driven target lesion revascularization or target lesion thrombosis through 6 months.
2. The primary safety endpoint was the proportion of patients who experienced an adverse event in the 30 days following treatment that negatively affected the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis).