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.

Academic Article

Abstract

  • PURPOSE: To 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 METHODS: Two 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. RESULTS: ACPP 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). CONCLUSIONS: Stent-graft use provided better ACPP and TAPP than PTA when treating in-stent restenosis in patients receiving dialysis with arteriovenous grafts and fistulae.

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    Keywords

  • Aged, Angioplasty, Balloon, Arteriovenous Shunt, Surgical, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation, Female, Graft Occlusion, Vascular, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Polytetrafluoroethylene, Prospective Studies, Prosthesis Design, Renal Dialysis, Reoperation, Risk Factors, Stents, Time Factors, Treatment Outcome, United States, Vascular Patency

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    Author List

  • Falk A; Maya ID; Yevzlin AS; RESCUE Investigators

    • Start Page

  • 1465

    • End Page

  • 1476

    • Volume

  • 27

    • Issue

  • 10