title: Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial.
abstract: OBJECTIVE
  To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG).
  
  
  METHODS
  The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1 ± 14.3 years) were randomized to undergo either PCB dilation (n = 20) or standard BA (n = 20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures).
  
  
  RESULTS
  Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006).
  
  
  CONCLUSIONS
  PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.
authors.affiliation: Department of Diagnostic and Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece. katsanos@med.upatras.gr
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Katsanos
authors.forename: Dimitris
authors.initials: D
authors.lastname: Karnabatidis
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Kitrou
authors.forename: Stavros
authors.initials: S
authors.lastname: Spiliopoulos
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Christeas
authors.forename: Dimitris
authors.initials: D
authors.lastname: Siablis
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects*; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D057785:Catheters; D003251:Constriction, Pathologic; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D006115:Greece; D006801:Humans; D053208:Kaplan-Meier Estimate; D007676:Kidney Failure, Chronic / Q000628:therapy; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011859:Radiography; D006435:Renal Dialysis; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel