Newly released six-month results from single-arm arteriovenous graft (AVG) cohort in the WAVE (Wrapsody arteriovenous access efficacy) trial showed target lesion and access circuit primary patency rates of nearly 82% and 68.8%, respectively.
The latest data on the Wrapsody cell-permeable endoprothesis (Merit Medical) for treatment of stenosis or occlusion within the dialysis access outflow circuit were revealed during the final day of the 2024 VEITHsymposium (19–23 November, New York, USA) by co-principal investigator Mahmood K Razavi (St. Joseph Heart & Vascular Center, Orange, USA). “In light of the historically low patency rates for AVG patients, the positive results from the AV graft arm of the WAVE trial are very encouraging for physicians who manage these patients,” he said.
The WAVE trial was designed to evaluate the efficacy and safety of the WRAPSODY endovascular stent graft across two cohorts: up to 244 AV fistula patients randomized 1:1 to either the Wrapsody device or percutaneous transluminal angioplasty, and the AVG cohort.
The graft arm enrolled 112 patients across 43 international sites. Primary efficacy and safety endpoints were assessed by comparing actual rates for the device to performance goals for covered stents (efficacy: 60%; safety: 89%). Efficacy of the Wrapsody device was 81.4%–21.4 percentage points higher than the performance goal (p<0.0001). The proportion of graft patients who were free from an adverse event was higher than the safety performance (95.4% vs. 89%, p=0.0162).
“As you well know,” Razavi told VEITH 2024, “these types of numbers are somewhat unusual in this patient population, having this kind of patency.”
The historical controls were based in three prior stent graft studies, he explained, with patency ranging between 50–71% at six months.
The proportion of graft patients who were free from an adverse event was higher than the safety performance (95.4% vs. 89%, p=0.0162).
“The patency results from the WAVE trial are the highest that I have seen to date and are expected to meaningfully improve patients’ quality of life and vascular access survival,” said WAVE trial investigator Leonardo Harduin (Universidade Federal do Estado, Rio de Janeiro, Brazil). “These results will probably have a positive impact on costs related to the care of these patients.”
The device is being investigated in the USA under a US Food and Drug Administration (FDA) investigational device exemption (IDE)
