IN.PACT AV Access Trial 24 Month Results Presented as a Podium First at Charing Cross Symposium
“A patient who receives hemodialysis will often need to have several reinterventions each year to maintain patency and keep critical access sites open and functioning properly,” said
AV fistulae are created and used to deliver hemodialysis to patients with ESRD. Over time, vessel restenosis limits the ability to use AV fistulae effectively. In order to restore function, patients often undergo one to three AV fistula maintenance procedures per year.3 The need for frequent reinterventions can result in significant disruptions to critical hemodialysis care and increased costs to the healthcare system. Drug-coated balloons have the potential to extend the time between reinterventions by maintaining AV access site patency, therefore maximizing a patient’s uninterrupted access to lifesaving dialysis care.
Over two years, the IN.PACT AV DCB group demonstrated a continued clinical benefit compared to the PTA control group. Key data highlights per Kaplan-Meier estimates for this dataset include:
- Target lesion primary patency through 24 months was 52.2% in the IN.PACT AV DCB group compared to 36.2% in the PTA control group (log-rank p<0.001).
- Access circuit primary patency through 24 months was 39.5% in the IN.PACT AV DCB group compared to 25.4% in the PTA control group (log-rank p<0.001).
- Freedom from all-cause mortality through 24 months was 82.4% in the IN.PACT AV DCB study group and 82.8% in the PTA control group (log-rank p=0.829).
“Medtronic is committed to providing physicians and patients with technology to improve dialysis access maintenance outcomes and reduce disruptions to care. Both our investment in this study as well as its results are a clear testament to this,” said
About the IN.PACT AV Access Study
The IN.PACT AV Access study is a prospective, global, single-blinded, randomized controlled trial (RCT), which enrolled 330 subjects at 29 sites in
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the
1 Holden, A.,
2 Trerotola SO, Saad TF, Roy-Chaudhury P; Lutonix AV Clinical Trial Investigators. The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis. J Vasc Interv Radiol.
3 THE USRDS Special Study Center. Transition of care in CKD. Prelude to Dialysis: Trends and Timely Transitions. Kalantar-Zadeh K. Et Al. 2016
4 Lookstein et al. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J Med 2020; 383:733-742.
View original content to download multimedia:http://www.prnewswire.com/news-releases/inpact-av-drug-coated-balloon-is-first-and-only-to-show-superior-and-sustained-results-through-two-years-compared-to-pta-in-treating-arteriovenous-fistulae-lesions-301270931.html