IN.PACT AV Access randomized trial update: 3-year clinical results by anatomic and demographic subsets and 5-year extension mortality analysis
PURPOSE: To report 36-month outcomes by anatomic and demographic subsets, and mortality through 60 months from the IN.PACT AV Access Study, a prospective, multicenter, randomized trial of a paclitaxel drug-coated balloon (DCB) versus percutaneous transluminal angioplasty (PTA) for dysfunctional hemodialysis arteriovenous fistulas (AVF). METHODS: The IN.PACT AV Access Study enrolled 330 participants at 29 international sites and randomized 1:1 to DCB (n = 170) or PTA (n = 160). Target lesion primary patency (TLPP) outcomes through 36 months were stratified by core laboratory-adjudicated anatomic subsets: lesion types (de novo and restenotic), AVF type (radiocephalic and brachiocephalic/ brachiobasilic), and lesion locations (peri-anastomotic, cephalic arch, and venous outflow). TLPP outcomes were also stratified by participant demographics. Mortality rates were reported through 60 months. RESULTS: Through 36 months, DCB showed numerically or statistically greater TLPP compared to PTA in de novo (50.6% versus 42.2%, p = 0.175) and restenotic (40.5% versus 22.7%, p < 0.001) lesions. Similarly, 36-month TLPP was significantly better for DCB compared to PTA in radiocephalic (44.5% versus 33.8%, p = 0.039) and brachiocephalic/ brachiobasilic (39.9% versus 21.3%, p = 0.011) AVFs. In lesion location subsets, 36-month TLPP was numerically greater with DCB versus PTA: peri-anastomotic (40.4% versus 31.1%, p = 0.047), cephalic arch (40.9% versus 27.9%, p = 0.079), and venous outflow (45.6% versus 25.5%, p = 0.048). Through 36 months, TLPP favored DCB treatment over PTA across race and sex. After incorporating additional vital status information, sixty-month freedom from all-cause mortality was 59.0% DCB versus 53.5% PTA (p = 0.510). CONCLUSION: Results showed sustained TLPP benefit for DCB compared to PTA in all subset analyses through 36 months and no mortality signal for DCB through 5 years. TRIAL REGISTRATION: ClinicalTrials.gov NCT03041467 . Registered 01 February 2017. LEVEL OF EVIDENCE: Level 1b, Randomized controlled trial.
Authors
- Adie Friedman
- Michael Dudkiewicz
- Kotaro Suemitsu (ORCID: https://orcid.org/0000-0002-4251-5315)
- Jun Kawachi (ORCID: https://orcid.org/0000-0001-6906-7949)
- Naomi Ota
- Husameddin El Khudari (ORCID: https://orcid.org/0000-0001-6846-1821)
- Kunihiro Ishioka (ORCID: https://orcid.org/0000-0001-9129-5075)
- Sreekumar Madassery (ORCID: https://orcid.org/0000-0002-4492-0058)
- Bret N. Wiechmann (ORCID: https://orcid.org/0000-0002-7022-497X)
- Katsunori Miyake (ORCID: https://orcid.org/0000-0001-8356-9646)
- Rai Shimoyama (ORCID: https://orcid.org/0000-0001-8601-0442)
- Takaaki Murata (ORCID: https://orcid.org/0000-0003-0053-7396)
- Chad Laurich
- Saho Kawanishi
- Kanako Oka
- L. Richard Sprouse
- Jennifer Seamans
- R. Lookstein (ORCID: https://orcid.org/0009-0001-4109-0634)
- Neghae Mawla
- Akihiro Higashimori (ORCID: https://orcid.org/0000-0001-9922-751X)
- Masahiko Fujihara (ORCID: https://orcid.org/0000-0002-7001-9220)
- Umar Waheed (ORCID: https://orcid.org/0000-0002-9000-1693)
- Haraldur Bjarnason (ORCID: https://orcid.org/0000-0003-0448-9168)
- Hiroaki Haruguchi (ORCID: https://orcid.org/0000-0001-5713-987X)
- Christopher Reisenauer
- Scott McEnroe
- Aslam Pervez
- Yuto Igarashi (ORCID: https://orcid.org/0000-0002-8605-0695)
- Andrew Holden (ORCID: https://orcid.org/0000-0002-8170-4960)
- Naoko Isogai (ORCID: https://orcid.org/0000-0003-3332-2527)
- Jeffrey E. Hull (ORCID: https://orcid.org/0000-0003-4094-5810)
- Sejan Patel
- Hong Wang (ORCID: https://orcid.org/0000-0001-5424-3946)
- Yoshiaki Yokoi (ORCID: https://orcid.org/0000-0002-6496-7515)
- Kevin Herman
- Alexander Hou
- Gordon Stokes
- Animesh Rathore
- Ahmed Kamel Abdel Aal
- Nobuyuki Morioka
- Fernando Kafie
- Mel Sharafuddin
- John Ross
- Wesley Mann
- Mohamed Sheta
- Jackson Ewart
- William Sharp
- Brendan O’Shea
- Sanjay Misra
- Hidemitsu Ogino
- David Hardy
- Jeff Horn
- Brian Miller
- Rohit Kashyap
- Angelo Santos
- Karthik Ramani
- Shengfu Wang
- Nikolaos Karagiorgos
- Shiliang Sun
- Yuma Sunou
- Jalal Hakmei
- Yuki Matsuoka
- Steven Beathard
- Patrick Kelly
- Syed Hussain
- John Rundback
- L. Kirksey
- Emily Bendel
- Sandeep Bagla
- Timothy Kresowik Md
- Huey McDaniel
- Sumi Hidaka
- Karn Gupta
- on behalf IN.PACT AV Access Investigators
- Erica Knavel
- Samuel Steerman
- Sean Lyden
- Jeffrey Hoggard
- Jennifer Ash
- Andrew Gunn
- Melissa Neisen
- Federico Parod
- Ronald Dreifuss
- Richard DeMasi
- Michael Greer
- Rachel Piechowiak
- Randy Cooper
- Charles Joels
- Naveen Atray
- Sandeep Laroia
- Paul Lewis
- Mark Fugate
- Newton Neider
- Rachel Oser
- Nathan Ertel
- David Dexter
- Andrew Stockland
- Nao Kum
- Mark London
- Omran Abul-Khoudoud
Institutions
- Auckland City Hospital (NZ)
- Medtronic (Ireland) (IE)
- Society of Interventional Radiology (US)
- Richmond Vascular Center (US)
- The Cardiac and Vascular Institute (US)
- Shonan Kamakura General Hospital (JP)
- Icahn School of Medicine at Mount Sinai (US)
Publication Details
- Journal
- CVIR Endovascular
- Published
- 2026-08-19
- DOI
- https://doi.org/10.1186/s42155-026-00746-z
- Primary Topic
- Central Venous Catheters and Hemodialysis
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Medtronic