Six-month safety and efficacy outcomes from the randomized-controlled arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial
Razavi, Mahmood K Balamuthusamy, Saravanan Makris, Angelo N Hoggard, Jeffrey G Harduin, Leonardo O Roy-Chaudhury, Prabir Jones, Robert G
Razavi, Mahmood K
Balamuthusamy, Saravanan
Makris, Angelo N
Hoggard, Jeffrey G
Harduin, Leonardo O
Roy-Chaudhury, Prabir
Jones, Robert G
Affiliation
St. Joseph Heart and Vascular Center; Texas Research Institute; Chicago Access Care; North Carolina Nephrology; University of Rio de Janeiro State; University of North Carolina Kidney Center; University Hospitals Birmingham NHS Foundation Trust
Other Contributors
Hohmann, Stephen
Cooper, Randy
Kafie, Fernando
Kirksey, Lee
Licht, Jonah
Mawla, Neghae
Mendes, Robert
Berman, Scott
Peden, Eric
Resnick, Scott
Saad, Theodore
Mitchell, Dana
You, Theodore
Jaffer, Ounali
Steiner, Kate
Rossi, Fabio
Rajan, Dheeraj
Abul-Khoudoud, Omran
Harlin, Stuart
Lessne, Mark L
Rogers, Tim
Watts, Micah
Khatib, Yazan
Siegel, Jeffrey
Molnar, Robert
Hentschel, Dirk
Illig, Karl A
Barroso, Thiago
Cavalcanti, Douglas
Metcalfe, James
Cooper, Randy
Kafie, Fernando
Kirksey, Lee
Licht, Jonah
Mawla, Neghae
Mendes, Robert
Berman, Scott
Peden, Eric
Resnick, Scott
Saad, Theodore
Mitchell, Dana
You, Theodore
Jaffer, Ounali
Steiner, Kate
Rossi, Fabio
Rajan, Dheeraj
Abul-Khoudoud, Omran
Harlin, Stuart
Lessne, Mark L
Rogers, Tim
Watts, Micah
Khatib, Yazan
Siegel, Jeffrey
Molnar, Robert
Hentschel, Dirk
Illig, Karl A
Barroso, Thiago
Cavalcanti, Douglas
Metcalfe, James
Publication date
2025-01-23
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Abstract
Stenosis within the arteriovenous fistula (AVF) of hemodialysis patients leads to vascular access dysfunction and inadequate hemodialysis. Percutaneous transluminal angioplasty (PTA) is the standard therapy for stenosis. However, rates of restenosis and loss of access patency remain high. Outcomes of a novel cell-impermeable endoprosthesis (CIE) have not been investigated in this setting. Therefore, our study was designed to address this as a prospective, international, multicenter pivotal trial (NCT04540302) with 245 patients with stenosis in their venous outflow circuit randomized to treatment: 122 receiving CIE and 123 receiving PTA across 43 international centers. Primary endpoints included target lesion primary patency (TLPP) at six months (freedom from clinically driven target lesion revascularization or target lesion thrombosis) and freedom from safety events through 30 days post-index procedure that affected the access circuit and resulted in reintervention, hospitalization, or death. Access circuit primary patency (ACPP) was evaluated as a secondary efficacy endpoint. Six-month TLPP and ACPP were significantly higher for the CIE cohort versus PTA (TLPP: 89.6% vs. 62.3%; ACPP: 72.2% vs. 57.0%). Thirty days post-index procedure, there was no statistically significant difference in the freedom from safety events for the CIE versus PTA (96.6 vs. 95.0%). No differences were observed in adverse events between either cohort. Our study shows that among patients with stenosis in their AVF, the CIE was superior to PTA with respect to six-month TLPP and ACPP with no observed difference in 30-day primary safety events.
Citation
Razavi MK, Balamuthusamy S, Makris AN, Hoggard JG, Harduin LO, Roy-Chaudhury P, Jones RG; WAVE Trial Investigators. Six-month safety and efficacy outcomes from the randomized-controlled arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial. Kidney Int. 2025 Apr;107(4):740-750. doi: 10.1016/j.kint.2025.01.006. Epub 2025 Jan 23.
Type
Article