A Prospective, Randomized Study of an Expanded Polytetrafluoroethylene Stent Graft versus Balloon Angioplasty for In-Stent Restenosis in Arteriovenous Grafts and Fistulae: Two-Year Results of the RESCUE Study

Abstract

PurposeTo assess the safety and efficacy of an expanded polytetrafluoroethylene stent graft versus balloon angioplasty for the treatment of in-stent restenosis in the venous outflow of hemodialysis access grafts and fistulae. Materials and MethodsTwo hundred seventy-five patients were randomized at 23 US sites to stent-graft placement or percutaneous transluminal angioplasty (PTA). Primary study endpoints were access circuit primary patency (ACPP) at 6 months and safety through 30 days; secondary endpoints were evaluated through 24 months. ResultsACPP at 6 months was significantly higher in the stent-graft group (18.6%) versus the PTA group (4.5%; P < .001), and freedom from safety events (30 days) was comparable (stent graft, 96.9%; PTA, 96.4%; P = .003 for noninferiority). The separation in ACPP survival curves remained through 12 months (stent graft, 6.2%; PTA, 1.5%). Treatment area primary patency (TAPP) was superior for the stent-graft group (66.4%) versus the PTA group (12.3%) at 6 months (P < .001), with a survivorship difference in favor of stent-graft placement maintained through 24 months (stent graft, 15.6%; PTA, 2.2%). ACPP and TAPP for the stent-graft group were better than those for the PTA group when compared within central and peripheral vein subgroups (P < .001). In central veins, TAPP was 13.6% in the stent-graft group versus 4.3% in the PTA group at 24 months (P < .001). ConclusionsStent-graft use provided better ACPP and TAPP than PTA when treating in-stent restenosis in patients receiving dialysis with arteriovenous grafts and fistulae.