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Drug-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Hemodialysis Fistulae: A Randomized Controlled Trial

Yiping Zhao1, Pei Wang2, Yuzhu Wang3

  • 1Vascular Surgery Department, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai Jiaotong University, Shanghai, China.

Clinical Journal of the American Society of Nephrology : CJASN
|January 8, 2024
PubMed

Insights

Paclitaxel-coated balloons significantly improve arteriovenous fistula patency compared to standard balloons, reducing reintervention rates. This drug-coated balloon therapy offers comparable safety for hemodialysis access.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Nephrology

Background:

  • Dysfunctional arteriovenous fistulae (AVF) pose a significant challenge in hemodialysis access.
  • Venous stenosis is a common cause of AVF dysfunction, leading to reduced treatment efficacy.
  • Paclitaxel-coated balloons (PCB) are being investigated as a treatment for stenotic lesions.

Purpose of the Study:

  • To evaluate the efficacy and safety of the AcoArt Orchid paclitaxel-coated balloon (PCB) in treating dysfunctional AV fistulae.
  • To compare PCB angioplasty with standard balloon angioplasty in patients with AVF stenosis.

Main Methods:

  • A prospective, multicenter, randomized controlled trial (AcoArt III/Arterio-venous Fistula in China, NCT03366727).
  • 244 patients with ≥50% venous stenosis in AV fistulae were randomized to PCB or uncoated balloon.
  • Primary efficacy assessed at 6 months (target lesion patency); safety assessed within 30 days; 12-month outcomes analyzed.

Main Results:

  • Primary target lesion patency at 6 months was 91% for PCB vs. 67% for plain balloon (P < 0.001).
  • 12-month patency was 66% for PCB vs. 46% for plain balloon (P = 0.004).
  • Fewer reinterventions were needed in the PCB group (0.39/patient) compared to the plain balloon group (0.77/patient) (P = 0.001); safety was comparable (P = 0.25).

Conclusions:

  • AcoArt Orchid PCB demonstrated superior primary patency rates at 6 and 12 months compared to plain balloon angioplasty.
  • PCB treatment for stenotic AV fistulae resulted in a significant reduction in the need for repeat interventions.
  • The safety profile of paclitaxel-coated balloons was comparable to standard balloons within one year.
Abstract

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