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
Journal of Vascular and Interventional Radiology(2016)
摘要
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 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 P P 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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关键词
ACPP,AV,CEC,CI,ePTFE,HR,IPF,ITT,KDOQI,PTA,TAPP
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