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Background <p>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.</p> <p>The IN.PACT AV Access Trial randomized 330 patients 1:1 to treatment with a DCB (<i>n</i> = 170) or uncoated percutaneous transluminal angioplasty (PTA; <i>n</i> = 160). This exploratory post-hoc analysis investigated core lab adjudicated vessel sizing in the context of target lesion primary patency (TLPP) outcomes through 36&#xa0;months. Participants were split into groups by median reference vessel diameter (RVD).</p> Results <p>The IN.PACT AV Access Trial randomized 330 patients 1:1 to treatment with a DCB (<i>n</i> = 170) or uncoated percutaneous transluminal angioplasty (PTA; <i>n</i> = 160). This exploratory post-hoc analysis investigated core lab adjudicated vessel sizing in the context of target lesion primary patency (TLPP) outcomes through 36&#xa0;months. Participants were split into groups by median reference vessel diameter (RVD).</p> Conclusions <p>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.</p> Trial registration <p><a href="https://clinicaltrials.gov/study/NCT03041467">NCT03041467</a>. Registered 25 April 2017.</p> Level of evidence <p>3</p> Graphical Abstract <p></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月14日

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

摘要

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