Accès ouvert déclaré 2026 article

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

Andrew Holden, Hiroaki Haruguchi, Kotaro Suemitsu, Naoko Isogai, Jeffrey E. Hull, Bret N. Wiechmann, Hong Wang, Jennifer Seamans, R. Lookstein, on behalf IN.PACT AV Access Investigators, L. Kirksey, Federico Parod, David Hardy, Sean Lyden, Sanjay Misra, Haraldur Bjarnason, Andrew Stockland, Newton Neider, 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 Md, William Sharp, Shengfu Wang, Sreekumar Madassery, David Dexter, Samuel Steerman, Animesh Rathore, Richard DeMasi, Gordon Stokes, Scott McEnroe, Charles Joels, Mark Fugate, Michael Greer, L. 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, Rai Shimoyama, Jun Kawachi, Takaaki Murata, Nao Kum, 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, 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, Brigid Connor, Stephen Merrilees, David Semple, Andrew Hill, Janaka Kesara, Wickremesekera, Richard Evans, Lupe Taumoepeau, Anantha Narayanan, Irina Baimatova

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Résumé fourni par la source

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.

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DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref: IN.PACT AV Access randomized trial update: 3-year clinical results by anatomic and demographic subsets and 5-year extension mortality analysis
Date Crossref: 19/08/2026
Éditeur: Springer Science and Business Media LLC
Type: journal-article

Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude et ne compte pas comme une seconde source scientifique indépendante.

Institutions déclarées

Auckland City Hospital Shonan Kamakura General Hospital Richmond Vascular Center Society of Interventional Radiology The Cardiac and Vascular Institute Medtronic (Ireland)Icahn School of Medicine at Mount Sinai

Une affiliation ne permet pas de déduire la nationalité d’un auteur.

Sujets associés

Central Venous Catheters and HemodialysisVascular Procedures and ComplicationsDiagnosis and Treatment of Venous Diseases

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