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IN.PACT AV Access randomized trial update: 3-year clinical results by anatomic and demographic subsets and 5-year

Andrew Holden1, Hiroaki Haruguchi2, Kotaro Suemitsu3

  • 1Department of Interventional Radiology, Auckland Hospital, Auckland, New Zealand. andrewh@adhb.govt.nz.

CVIR Endovascular
|August 19, 2026
PubMed

Insights

The drug-coated balloon (DCB) demonstrated sustained target lesion primary patency benefits over percutaneous transluminal angioplasty (PTA) for hemodialysis arteriovenous fistulas through 36 months, with no increased mortality observed over 5 years.

Area of Science:

  • Vascular Surgery
  • Interventional Radiology
  • Nephrology

Background:

  • The IN.PACT AV Access Study is a prospective, multicenter, randomized trial evaluating drug-coated balloons (DCB) against percutaneous transluminal angioplasty (PTA).
  • This study focuses on dysfunctional hemodialysis arteriovenous fistulas (AVF).
  • The trial is registered under NCT03041467.

Purpose of the Study:

  • To report 36-month outcomes stratified by anatomic and demographic subsets for DCB versus PTA in AVF treatment.
  • To assess all-cause mortality through 60 months in the IN.PACT AV Access Study.

Main Methods:

  • 330 participants were randomized 1:1 to receive either DCB or PTA.
  • Target lesion primary patency (TLPP) was assessed through 36 months.
  • Outcomes were analyzed across various lesion types, AVF types, lesion locations, and participant demographics. Mortality was tracked through 60 months.

Main Results:

  • DCB showed superior 36-month TLPP compared to PTA in de novo (50.6% vs 42.2%) and restenotic lesions (40.5% vs 22.7%).
  • Significant TLPP benefits for DCB were observed in radiocephalic (44.5% vs 33.8%) and brachiocephalic/brachiobasilic AVFs (39.9% vs 21.3%).
  • DCB also demonstrated numerical TLPP advantages in peri-anastomotic, cephalic arch, and venous outflow lesions, and across race and sex demographics. 60-month mortality was comparable (59.0% DCB vs 53.5% PTA).

Conclusions:

  • Drug-coated balloons offer a sustained TLPP benefit over PTA for AVF treatment across all analyzed subsets up to 36 months.
  • The study found no increased mortality signal associated with DCB use through 5 years.
  • DCB represents a safe and effective option for maintaining AVF patency in hemodialysis patients.
Abstract

Keywords:
Arteriovenous fistulasBrachiobasilicBrachiocephalicCephalic archDrug-coated balloonPTAPeri-anastomoticRaceRadiocephalicSexVenous outflow

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