Dr. Eric Therasse discusses the results of a randomized clinical trial demonstrating benefit of drug eluting balloon (DEB) over balloon angioplasty alone in treatment of Dysfunctional Hemodialysis Access.

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SHOW NOTES

In this episode, Dr. Eric Therasse, an author of the recent JVIR article titled “Safety and Efficacy of Paclitaxel-Eluting Balloon Angioplasty for Dysfunctional Hemodialysis Access,” and our host Dr. Christopher Beck discuss the study design, outcomes, and implications for further research in the use of drug eluting balloons (DEBs) for hemodialysis access.

In this study, the control group received “plain old balloon angioplasty” (POBA), while the treatment group received angioplasty with Biotronik’s Passeo 18-Lux DEB. Dr. Therasse describes the angiographic endpoints, with primary endpoint as late lumen loss (to measure the degree of restenosis), and secondary endpoints as hemodialysis access failure and mortality at 12 months. He emphasizes that the clinical endpoints of this study were more significant than the angiographic endpoints because they showed that when treating dysfunctional hemodialysis access, there is decreased incidence and severity of restenosis with DEB compared with POBA.

Additionally, the doctors walk through obstacles that arose during the study, which included coordination of data collection across multiple centers, low patient enrollment rate, strict exclusion criteria, and the need for re-intervention prior to the standardized follow up date. Dr. Therasse comments on the increasing use of DEBs in clinical practices and their future cost-effectiveness. He also references other helpful articles for interested listeners (linked below).

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RESOURCES

Safety and Efficacy of Paclitaxel-Eluting Balloon Angioplasty for Dysfunctional Hemodialysis Access: https://www.jvir.org/article/S1051-0443(20)30961-1/fulltext

Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas: https://www.nejm.org/doi/10.1056/NEJMoa1914617?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: https://www.jvir.org/article/S1051-0443(19)30817-6/fulltext