Six-month safety and efficacy outcomes from the randomized-controlled arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial
Mahmood K. Razavi, Saravanan Balamuthusamy, Angelo Makris, Jeffrey Hoggard, Leonardo O Harduin, Prabir Roy‐Chaudhury, Robert G. Jones, Robert G. Jones, Mahmood K. Razavi, Mahmood K. Razavi, Andrew Wigham, Sanford Altman, Christopher Carsten, Thomas Casciani, David Dexter, Paul Gagne, Jeffrey G. Hoggard, Stephen Hohmann, Randy Cooper, Fernando Kafie, Lee Kirksey, Jonah Licht, Angelo N. Makris, Neghae Mawla, Robert Mendes, Joseph Sabat, Eric Peden, Scott Resnick, Prabir Roy-Chaudhury, Theodore Saad, Dana Mitchell, Theodore Yuo, Ounali Jaffer, Robert G. Jones, Kate Steiner, Fabio Rossi, Dheeraj Rajan, Saravanan Balamuthusamy, Omran Abul-Khoudoud, Stuart Harlin, Mark L. Lessne, Leonardo Harduin, Tim Rogers, Micah Watts, Yazan Khatib, Jeffrey Siegel, Robert Molnar, Dirk Hentschel, Karl A. Illig, Thiago Barroso, Douglas Cavalcanti, James Metcalfe
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.