Medtronic’s In.Pact AV DCB Compared to PTA at 36 Months in IN.PACT AV Access Study

April 27, 2022—Medtronic announced the presentation of new 36-month data from the randomized controlled IN.PACT AV Access study comparing the company’s In.Pact AV drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) in patients with de novo or nonstented restenotic arteriovenous (AV) fistula lesions. The data were presented at the Charing Cross International Symposium 2022 held April 26-28 in London, United Kingdom.

According to the company, the IN.PACT AV Access study’s 3-year data further demonstrated the ability for the In.Pact AV DCB to extend time to reinterventions from the index procedure by maintaining AV access site patency, therefore maximizing a patient’s uninterrupted access to lifesaving dialysis care.

In 3 years, the In.Pact AV DCB group demonstrated a continued clinical benefit compared to the PTA control group with no difference in mortality.

Medtronic reported that highlights for the In.Pact AV DCB group versus the PTA control group at 36 months included the following data:

• Kaplan-Meier estimated target lesion primary patency (43.1% vs 28.6%; log-rank P < .001)
• Kaplan-Meier estimated access circuit primary patency (26.4% vs 16.6%; log-rank P < .001)
• Kaplan-Meier estimated cumulative incidence of all-cause mortality post vital status update (26.6% vs 30.8%; log-rank P = .709)

Andrew Holden, MBChB, director of interventional radiology and associate professor of radiology, Auckland University School of Medicine in Auckland, New Zealand, commented in Medtronic’s press release, “The 36-month data from the IN.PACT AV Access study validates that treatment with the In.Pact AV DCB can lead to less life disruption and fewer reinterventions for patients for an extended period of time, further reinforcing the results of earlier data milestones.”

Dr. Holden, who is coprincipal investigator of the study, continued, “As the only pivotal DCB study in AV access to meet its primary effectiveness endpoint, the In.Pact AV DCB has shown unrivalled long-term clinical benefits that support its use as standard of care for AV fistula maintenance in patients with end stage kidney disease.”

The company advised that in August 2020 the primary endpoint results from IN.PACT AV Access study were published by Robert A. Lookstein, MD, et al in The New England Journal of Medicine (2020;383:733-742).