Introduction:
The development of venous outflow circuit stenosis/occlusion within the arteriovenous graft or fistula (AVG/AVF) is a common, and potentially life-threatening, complication in patients on hemodialysis. However, there are limited treatment options available to restore access circuit patency. Prolonging vascular access has important implications for physicians and patients. WRAPSODY is a unique covered stent with flexible ends and a cell impermeable layer was specifically developed to help prolong vascular access patency by reducing cell migration and neointimal hyperplasia.
Methods:
This prospective, multicenter, international trial (the WAVE Study; NCT04540302) was conducted across 43 centers in the United States, South America, and the United Kingdom. Patients with venous outflow stenosis or occlusion were enrolled in either the AVG or AVF cohort based on their hemodialysis access. The AVG arm was a single cohort. The primary safety endpoint was the proportion of patients without any localized or systemic safety events through 30 days affecting the access of the venous outflow circuit and resulted in a reintervention, hospitalization, or death. The primary efficacy endpoint was the proportion of patients with 6-month target lesion primary patency (TLPP) defined as freedom from clinically-driven target lesion revascularization or target lesion thrombosis. Safety and efficacy outcomes of the AVG cohort were compared to performance goals (TLPP benchmark: 60%; safety benchmark: 89%). Patients in the AVF cohort were randomized (1:1) to treatment with WRAPSODY or percutaneous transluminal angioplasty (PTA).
Results:
A total of 113 patients were included in the AVG cohort. Six-month TLPP was significantly higher than the effectiveness performance goal (81.4% vs. 60%; p<0.001). The proportion of patients in the AVG cohort without a safety event was significantly higher than the safety performance goal (95.4% vs. 89%; p=0.0162). In comparison, 245 patients in the AVF cohort were randomized to WRAPSODY (n=122) or PTA (n=123). Patients were well-matched on demographics, medical history, and target lesion characteristics. Six-month TLPP was significantly higher in patients treated with WRAPSODY versus PTA (89.6% vs. 62.3%; p<0.0001). No statistically significant difference in safety events was observed 30 days post procedure (WRAPSODY: 3.4; PTA: 5.0%; p=0.54).
Conclusions:
The results suggest WRAPSODY may be a promising alternative for treating venous stenosis/occlusion in the venous outflow circuit.
Portions of this data would have been presented at ASN Kidney Week 2024.
I have potential conflict of interest to disclose.
Study was funded by Merit Medical
I did not use generative AI and AI-assisted technologies in the writing process.