Inside Access is a new column from IR Quarterly that provides interviews and behind-the-scenes 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 JVIR.
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
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 observed a significant reduction in the incidence of access circuit thrombosis at the 36-month follow-up period. There were no concerns regarding safety at 36 months when the two cohorts were evaluated.
What do you consider the impact of these findings?
RL: The major findings were that the use of the IN.PACT AV DCB demonstrated continued and sustained clinical benefit at 36 months as demonstrated by primary patency of the target lesion, primary patency of the hemodialysis access and freedom from access circuit thrombosis.
What has been the response to these results thus far?
RL: Increasingly, vascular specialists who perform hemodialysis maintenance procedures are using these devices largely based on their clinical superiority as compared to plain balloon angioplasty.
What are the next steps? Any additional research planned?
RL: There is currently a prospective multicenter registry evaluating real-world applications of this technology, including use in AV grafts, in central veins and in-stent stenosis.
Is there anything not outlined in the paper that readers should know?
RL: This is the first prospective randomized trial with an independent core lab to demonstrate sustained clinical benefit of a DCB for AV fistula maintenance out to 36 months.
At a glance
- The IN.PACT AV Access study demonstrated a superior treatment effect of drug-coated balloons (DCBs) compared to percutaneous transluminal angioplasty (PTA) through 6 and 12 months, an effect durable through 24 and 36 months.
- Access circuit thrombosis is significantly lower in the DCB group than in the PTA group through 36 months, which is clinically relevant given the impact thrombosis has on patients and their vascular access.
- Two large, multicenter, adjudicated DCB trials (Lutonix AV and IN.PACT AV Access) demonstrated similar mortality rates between the DCB and PTA groups through 24 and 36 months, respectively, creating a definitive reference demonstrating the safety of DCB for the treatment of patients with end-stage kidney disease.
Key insights pulled from JVIR.
