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

J Endovasc Ther. 2012 Apr;19(2):263-72. doi: 10.1583/11-3690.1.


Purpose: 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).

Conclusion: PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.

Trial registration: NCT01174472.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Arteriovenous Shunt, Surgical / adverse effects*
  • Blood Vessel Prosthesis Implantation / adverse effects*
  • Cardiovascular Agents / administration & dosage*
  • Catheters*
  • Constriction, Pathologic
  • Drug Delivery Systems / instrumentation*
  • Equipment Design
  • Female
  • Graft Occlusion, Vascular / diagnostic imaging
  • Graft Occlusion, Vascular / etiology
  • Graft Occlusion, Vascular / physiopathology
  • Graft Occlusion, Vascular / therapy*
  • Greece
  • Humans
  • Kaplan-Meier Estimate
  • Kidney Failure, Chronic / therapy
  • Male
  • Middle Aged
  • Paclitaxel / administration & dosage*
  • Proportional Hazards Models
  • Prospective Studies
  • Radiography
  • Renal Dialysis*
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Vascular Patency


  • Cardiovascular Agents
  • Paclitaxel

Associated data