title: 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: OBJECTIVE
  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.
  
  
  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.
authors: Fresenius Vascular Care, New York, New York. Electronic address: abigail.falk@gmail.com.
authors: Abigail
authors: A
authors: Falk
authors: Nephrology Associates of Central Florida, Orlando, Florida.
authors: Ivan D
authors: ID
authors: Maya
authors: Department of Medicine, Division of Nephrology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
authors: Alexander S
authors: AS
authors: Yevzlin
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation*; D005260:Female; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D011474:Prosthesis Design; D006435:Renal Dialysis; D012086:Reoperation; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014654:Vascular Patency
chemical_list: D011138:Polytetrafluoroethylene