Inside access Robert A. Lookstein, MD, FSIR


Outcomes of the IN.PACT AV Access trial


IN.PACT AV access randomized trial of drug-coated balloons for dysfunctional arteriovenous fistulae: Clinical outcomes through 36 months


Lookstein R, Haruguchi H, Suemitsu K, Roffe PS, Holden A. JVIR. 2023;34(12). DOI: doi.org/10.1016/j.jvir.2023.07.007


Inside Access is a new column from IR Quarterly that provides interviews and behind-the-scenes insight on open access articles from the Journal of Vascular and Interventional Radiology. Read the full article and learn more about JVIR’s open access options at the the journal's website, jvir.org.


What was the focus of the study? Robert A. Lookstein, MD, FSIR: The study was a prospective randomized trial evaluating the safety and efficacy of the IN.PACT arteriovenous drug- coated balloon (DCB) as compared to plain balloon angioplasty in the treatment of dysfunctional AV fistulae for hemodialysis. The trial was designed to demonstrate the superiority of DCBs (specifically the IN.PACT AV balloon) for this clinical application.


What were the key takeaways? RL: The original clinical findings at 6 months were published in the New England Journal of Medicine and subsequently led to the balloon receiving approval from the U.S. Food and Drug Administration for this clinical application. This manuscript in JVIR reviewed the 36-month outcomes. Specifically, there was sustained clinical benefit observed at a 36-month follow-up. Interestingly, we


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