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