title: Prospective, Randomized, Concurrently-Controlled Study of a Stent Graft versus Balloon Angioplasty for Treatment of Arteriovenous Access Graft Stenosis: 2-Year Results of the RENOVA Study.
abstract: OBJECTIVE
  To present final, 2-year data from randomized comparison of an expanded polytetrafluoroethylene stent graft (SG) and percutaneous transluminal angioplasty (PTA) for treatment of arteriovenous graft (AVG) anastomotic stenoses.
  
  
  METHODS
  A 28-site, prospective, controlled US study enrolled 270 patients with malfunctioning AVG anastomotic stenoses of ≥ 50%; 138 patients underwent SG placement, and 132 underwent PTA alone. Follow-up imaging and intervention were event-driven.
  
  
  RESULTS
  The study was completed by 191 patients (97 SG, 94 PTA). Five patients were lost to follow-up or withdrew; 74 patients died during the study (38 SG, 36 PTA). At 12 months, treatment area primary patency (TAPP) was SG 47.6% versus PTA 24.8% (P < .001), access circuit primary patency (ACPP) was SG 24% versus PTA 11% (P = .007), and index of patency function (IPF) was SG 5.2 months/intervention ± 4.1 versus PTA 4.4 months/intervention ± 3.5 (P = .009). At 24 months, TAPP was SG 26.9% versus PTA 13.5% (P < .001), ACPP was SG 9.5% versus PTA 5.5% (P = .01), and IPF was SG 7.1 months/intervention ± 7.0 versus PTA 5.3 months/intervention ± 5.2; estimated number of reinterventions before graft abandonment was 3.4 for SG patients versus 4.3 for PTA patients. There were no significant differences in adverse events (P > .05) except for restenosis requiring reintervention rates of 82.6% in PTA patients versus 63.0% in SG patients (P < .001).
  
  
  CONCLUSIONS
  At 2 years, SG use provided a sustained, greater than 2-fold advantage over PTA in treatment area and overall access patency. Time to subsequent intervention was longer in the SG group.
authors.affiliation: Department of Radiology and Medical Imaging, University of Virginia School of Medicine, 1215 Lee Street, Charlottesville, VA 22908. Electronic address: Ziv2@mac.com.
authors.forename: Ziv J
authors.initials: ZJ
authors.lastname: Haskal
authors.affiliation: Nephrology Associates Vascular Access Center, Newark, Delaware.
authors.forename: Theodore F
authors.initials: TF
authors.lastname: Saad
authors.affiliation: Capital Access Center, Raleigh, North Carolina.
authors.forename: Jeffery G
authors.initials: JG
authors.lastname: Hoggard
authors.affiliation: SKI Vascular Center, Tempe, Arizona.
authors.forename: Randy I
authors.initials: RI
authors.lastname: Cooper
authors.affiliation: Baystate Medical Center, Springfield, Massachusetts.
authors.forename: George S
authors.initials: GS
authors.lastname: Lipkowitz
authors.affiliation: Universal Vascular Center, El Paso, Texas.
authors.forename: Anwar
authors.initials: A
authors.lastname: Gerges
authors.affiliation: Dialysis Access Institute, Orangeburg, South Carolina.
authors.forename: John R
authors.initials: JR
authors.lastname: Ross
authors.affiliation: Illinois Kidney Disease and Hypertension Center, Peoria, Illinois.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Pflederer
authors.affiliation: Vascular & Interventional Care Center, Augusta, Georgia.
authors.forename: Samuel W
authors.initials: SW
authors.lastname: Mietling
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 / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011474:Prosthesis Design; D006435:Renal Dialysis; D019233:Retreatment; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014654:Vascular Patency
chemical_list: D011138:Polytetrafluoroethylene