title: Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts.
abstract: OBJECTIVE
  To compare the results of stent graft placement to balloon angioplasty for the treatment of stenosis at the venous anastomosis of failing and thrombosed prosthetic hemodialysis grafts.
  
  
  METHODS
  This prospective, multicenter trial included 293 patients randomized (1:1) to the stent graft (n = 145) or balloon angioplasty (n = 148) group for treatment of stenosis at the venous anastomosis of dysfunctional (n = 164) or thrombosed (n = 129) hemodialysis grafts. The primary study end point was target lesion primary patency at 6 months; participants were followed for up to 24 months. Primary patency of the access circuit was a secondary end point. Statistical analysis of effectiveness was performed using both the intent-to-treat population and the effectiveness-per-protocol (EPP) populations for primary patency end points. Statistical analysis of additional effectiveness end points was performed using the EPP population.
  
  
  RESULTS
  The 6-month target lesion primary patency was statistically greater in the stent graft group than the balloon angioplasty group (intent-to-treat, 51.6% vs 34.2% [P = .006]; EPP, 52.9% vs 35.5% [P = .008]). Compared with the angioplasty group, the stent graft group increased the median time from the index procedure to the next intervention on the target lesion by 95 days (203 vs 108 days). Patients with dysfunctional (stenotic) grafts had higher target lesion primary patency compared with patients with thrombosed grafts regardless of treatment (EPP, stent graft, 64.6% vs 36.1% and balloon angioplasty, 45.8% vs 23.5%). When compared with angioplasty, using a stent graft for treatment of a venous anastomotic stenosis of a thrombosed graft increased the 6-month target lesion primary patency by 53.6% (EPP, 36.1% vs 23.5%).
  
  
  CONCLUSIONS
  When compared with balloon angioplasty, a stent graft provided superior target lesion primary patency at 6 months for treatment of venous anastomotic stenoses of dysfunctional and thrombosed prosthetic hemodialysis grafts.
authors.affiliation: Vascular Access Services, Saint Louis, Mo. Electronic address: tmvesely@gmail.com.
authors.forename: Thomas
authors.initials: T
authors.lastname: Vesely
authors.affiliation: Palmyra Medical Center, St. Simons Island, Ga.
authors.forename: William
authors.initials: W
authors.lastname: DaVanzo
authors.affiliation: San Diego Vascular Access Center, San Diego, Calif.
authors.forename: Terry
authors.initials: T
authors.lastname: Behrend
authors.affiliation: Department of Medicine, University of Louisville, Louisville, Ky.
authors.forename: Amy
authors.initials: A
authors.lastname: Dwyer
authors.affiliation: Department of Radiology & Biomedical Imaging, Yale University School of Medicine, New Haven, Conn.
authors.forename: John
authors.initials: J
authors.lastname: Aruny
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects* / Q000295:instrumentation*; 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; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D006435:Renal Dialysis; D012086:Reoperation; D012307:Risk Factors; D015607:Stents; D013927:Thrombosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014654:Vascular Patency