title: Paclitaxel-coated versus plain balloon angioplasty for dysfunctional arteriovenous fistulae: one-year results of a prospective randomized controlled trial.
abstract: OBJECTIVE
  To report 1-year results of a single-center randomized controlled trial comparing paclitaxel-coated balloon (PCB) versus high-pressure plain balloon angioplasty for the treatment of failing arteriovenous fistulae (AVFs).
  
  
  METHODS
  Forty patients (26 men; mean age, 61 y ± 14.63) were randomized at 1:1 to undergo PCB (n = 20) or high-pressure balloon (HPB; n = 20) angioplasty of dysfunctional AVFs. There were no significant differences in baseline demographics between groups. Enrollment required a clinical diagnosis of a dysfunctional AVF attributed to a single stenotic lesion verified with digital subtraction angiography. Primary endpoints included device success, anatomic success, clinical success, and target lesion revascularization (TLR)-free survival. Secondary endpoints included dialysis circuit primary patency and procedure-related complication rates.
  
  
  RESULTS
  Device success rates were 100% in the HPB group and 35% in the PCB group (P < 0001): further dilation with an HPB was needed to achieve anatomic success in 13 of 20 cases in the PCB group (65%). Anatomic and clinical success rates were 100% in both groups. TLR-free survival (PCB, 308 d; HPB, 161 d; hazard ratio [HR], 0.478; 95% confidence interval [CI], 0.236-0.966; P = .03) and access circuit primary patency (PCB, 270 d; HPB, 161 d; HR, 0.479; 95% CI, 0.237-0.968; P = .04) were significantly in favor of PCB angioplasty. No minor or major procedure-related complications occurred.
  
  
  CONCLUSIONS
  In this single-center study, the use of PCBs resulted in superior TLR-free survival and dialysis access circuit primary patency of dysfunctional AVFs. However, additional HPB postdilation was required in the majority of cases.
authors.affiliation: Interventional Radiology Department, Patras University Hospital, Patras, Achaia 26500, Greece.
authors.forename: Panagiotis M
authors.initials: PM
authors.lastname: Kitrou
authors.affiliation: Interventional Radiology Department, Patras University Hospital, Patras, Achaia 26500, Greece.. Electronic address: stavspiliop@upatras.gr.
authors.forename: Stavros
authors.initials: S
authors.lastname: Spiliopoulos
authors.affiliation: Interventional Radiology Department, Guy's and St. Thomas Hospitals National Health Service Foundation Trust, London, United Kingdom.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Katsanos
authors.affiliation: Nephrology Department, Patras University Hospital, Patras, Achaia 26500, Greece.
authors.forename: Evangelos
authors.initials: E
authors.lastname: Papachristou
authors.affiliation: Interventional Radiology Department, Patras University Hospital, Patras, Achaia 26500, Greece.
authors.forename: Dimitris
authors.initials: D
authors.lastname: Siablis
authors.affiliation: Interventional Radiology Department, Patras University Hospital, Patras, Achaia 26500, Greece.
authors.forename: Dimitris
authors.initials: D
authors.lastname: Karnabatidis
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000379:methods*; D001166:Arteriovenous Shunt, Surgical; D003131:Combined Modality Therapy / Q000295:instrumentation; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D006435:Renal Dialysis / Q000295:instrumentation* / Q000379:methods; D012086:Reoperation / Q000295:instrumentation; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage
chemical_list: D050257:Tubulin Modulators; D017239:Paclitaxel