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J Vasc Interv Radiol · Oct 2016
Randomized Controlled Trial Multicenter Study Comparative StudyA 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.
- Abigail Falk, Ivan D Maya, Alexander S Yevzlin, and RESCUE Investigators.
- Fresenius Vascular Care, New York, New York. Electronic address: abigail.falk@gmail.com.
- J Vasc Interv Radiol. 2016 Oct 1; 27 (10): 1465-76.
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.Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.
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