Vessel and balloon sizing in the IN.PACT AV access trial: post-hoc analysis of procedural characteristics and outcomes

Abstract Background Drug-coated balloons (DCBs) have demonstrated effectiveness and safety in the treatment of dysfunctional arteriovenous fistulas used for hemodialysis in larger randomized studies; however, the patient and lesion profiles that have the best DCB outcomes remain undefined. Pivotal trials with core lab adjudication are ideal to generate hypotheses for future studies of intra-procedural characteristics given they include both site-reported and independently assessed data. The IN.PACT AV Access Trial randomized 330 patients 1:1 to treatment with a DCB ( n = 170) or uncoated percutaneous transluminal angioplasty (PTA; n = 160). This exploratory post-hoc analysis investigated core lab adjudicated vessel sizing in the context of target lesion primary patency (TLPP) outcomes through 36 months. Participants were split into groups by median reference vessel diameter (RVD). Results The IN.PACT AV Access Trial randomized 330 patients 1:1 to treatment with a DCB ( n = 170) or uncoated percutaneous transluminal angioplasty (PTA; n = 160). This exploratory post-hoc analysis investigated core lab adjudicated vessel sizing in the context of target lesion primary patency (TLPP) outcomes through 36 months. Participants were split into groups by median reference vessel diameter (RVD). Conclusions This post hoc analysis identified that intra-procedural sizing decisions have the potential to positively impact outcomes in patients with dysfunctional fistula lesions. These findings warrant further prospective evaluation to define optimal DCB sizing strategies. Trial registration NCT03041467 . Registered 25 April 2017. Level of evidence 3 Graphical Abstract

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Journal
CVIR Endovascular
Published
2026-02-14
DOI
https://doi.org/10.1186/s42155-026-00650-6
Primary Topic
Central Venous Catheters and Hemodialysis
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article
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article

Vessel and balloon sizing in the IN.PACT AV access trial: post-hoc analysis of procedural characteristics and outcomes

Erica M. Knavel, Adie Friedman, Janaka K. Wickremesekera, Omran Abul-Khoudoud et al.
CVIR Endovascular
Central Venous Catheters and Hemodialysis
article

Vessel and balloon sizing in the IN.PACT AV access trial: post-hoc analysis of procedural characteristics and outcomes

Erica M. Knavel, Adie Friedman, Janaka K. Wickremesekera, Omran Abul-Khoudoud, Rachel Oser, Melissa Neisen, Yoshiki Matsuo, Michael Dudkiewicz, Kotaro Suemitsu, Sandeep Laroia, Masaaki Murakami, Mark London, Sachiko Hirotani, Naomi Ota, Michael S. Greer, Tomofumi Tsukizawa, Christopher J. Reisenauer, Katsunori Miyake, Shunsuke Okamura, Yuma Tanabe, Takaaki Murata, Emily C. Bendel, Nozomi Abe, Sean P. Lyden, Chad Laurich, Saho Kawanishi, Kanako Oka, L. Richard Sprouse, Jennifer Ash, Tatsuro Sano, Keisuke Fukuda, David Semple, David Trevor Dexter, Kensuke IgarashiTomohiko Kuwabara, Lupe Taumoepeau, Nathan Ertel, Timothy F. Kresowik, Richard J. DeMasi, Newton B. Neidert, Jeffrey Hoggard, Charles S. Joels, Karn Gupta, Paul D. Lewis, Neghae Mawla, Randy I. Cooper, Bridget A. Wall, Kevin Herman, Masahiko Fujihara, Umar Waheed, Kiyoshi Mori, Naveen K. Atray, Irina Baimatova, Samuel Steerman, Ronald Dreifuss, Mark W. Fugate, Ryo Yamada, Stephen Merrilees, Scott McEnroe, Aslam Pervez, Naoko Isogai, Andrew J. Gunn, R. Lookstein, Tota Kiba, Andrew H. Stockland, Sandeep Bagla, Shinji Shiotani, Rachel Piechowiak, Yuichiro Kawai, Sejan Patel, Hiroaki Hara, Takeshi Hachisuka, Bret N. Wiechmann, Tomonari Ogawa, 日高 寿美, Kenta Ito, Yu Soma, Akira Kondo, Noriko Mori, Alexander Hou, Ken Matsuo, Animesh Rathore, Hajime Hasegawa, Nobuyuki Morioka, Yoshimi Okada, Shohei Fuchinoue, Huey G. McDaniel, Katsuyuki Miki, Takao Okawa, Fernando Kafie, Haraldur Bjarnason, Mel Sharafuddin, Husameddin El Khudari, John Ross, Kakuya Hagiwara, Wesley Mann, Yuichi Ogawa, Jun Kawachi, Kento Hirose, Kotaro Kai, Mohamed Sheta, Jackson Ewart, William Sharp, Brendan O’Shea, Sanjay Misra, Hidemitsu Ogino, David Hardy, Toru Hida, Hong Wang, Kunihiko Yasuda, Ahmed Kamel Abdel Aal, Jeff Horn, Brian Miller, Anantha Narayanan, Levester Kirksey, Nao Kume, Hiroaki Haruguchi, Rohit Kashyap, Kunihiro Ishioka, Angelo Santos, Karthik Ramani, Jeffrey Hull, Federico Parodi, Shengfu Wang, Koki Ogawa, Akihiro Higashimori, Kazuhiro Iwadoh, Ichiro Nakajima, Yoshihiro Yamamoto, Yuki Ito, Sayaka Morita, Shota Kimura, Nikolaos Karagiorgos, Richard Evans, Shiliang Sun, Brendan Buckley, Sreekumar Madassery, Yuto Igarashi, Yuma Sunou, Akira Sugawara, Jalal Hakmei, Andrew Hill, Andrew Holden, Yuki Matsuoka, Steven Beathard, Patrick Kelly, Yoko Matsuo, IN.PACT AV Access Investigators, Syed Hussain, John Rundback, Gordon Stokes
article en

Abstract

Abstract Background Drug-coated balloons (DCBs) have demonstrated effectiveness and safety in the treatment of dysfunctional arteriovenous fistulas used for hemodialysis in larger randomized studies; however, the patient and lesion profiles that have the best DCB outcomes remain undefined. Pivotal trials with core lab adjudication are ideal to generate hypotheses for future studies of intra-procedural characteristics given they include both site-reported and independently assessed data. The IN.PACT AV Access Trial randomized 330 patients 1:1 to treatment with a DCB ( n = 170) or uncoated percutaneous transluminal angioplasty (PTA; n = 160). This exploratory post-hoc analysis investigated core lab adjudicated vessel sizing in the context of target lesion primary patency (TLPP) outcomes through 36 months. Participants were split into groups by median reference vessel diameter (RVD). Results The IN.PACT AV Access Trial randomized 330 patients 1:1 to treatment with a DCB ( n = 170) or uncoated percutaneous transluminal angioplasty (PTA; n = 160). This exploratory post-hoc analysis investigated core lab adjudicated vessel sizing in the context of target lesion primary patency (TLPP) outcomes through 36 months. Participants were split into groups by median reference vessel diameter (RVD). Conclusions This post hoc analysis identified that intra-procedural sizing decisions have the potential to positively impact outcomes in patients with dysfunctional fistula lesions. These findings warrant further prospective evaluation to define optimal DCB sizing strategies. Trial registration NCT03041467 . Registered 25 April 2017. Level of evidence 3 Graphical Abstract

CVIR EndovascularVol. 9(1)
Auckland City Hospital (NZ), Society of Interventional Radiology (US), Medtronic (United States) (US), Richmond Vascular Center (US), The Cardiac and Vascular Institute (US), Shonan Kamakura General Hospital (JP), Icahn School of Medicine at Mount Sinai (US)
Boston Scientific Corporation, Abbott Vascular
Good health and well-being
Openalex Percentile: Top 60%
Central Venous Catheters and Hemodialysis
DOIOpen Access PDFOpenAlex
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