Medtronic’s IN.PACT AV Access Study Subanalysis Data Presented

April 26, 2023—Medtronic announced the presentation of additional 36-month data from a subanalysis of the IN.PACT AV Access study, as well as 48-month vital status outcomes.

The IN.PACT AV Access study is a randomized controlled trial comparing the company’s In.Pact AV drug-coated balloon (DCB) to standard percutaneous transluminal angioplasty (PTA) in patients with de novo or nonstented restenotic arteriovenous (AV) fistula lesions.

The data were presented by Professor Andrew Holden, MBChB, at CX 2023, the Charing Cross International Symposium (CXS) held April 25-27 in London, United Kingdom. Prof. Holden, who serves as a principal investigator of the IN.PACT AV Access study, is Director of Interventional Radiology and Associate Professor of Radiology at Auckland University School of Medicine in Auckland, New Zealand.

According to the company, the presentation showed durable, long-term results that demonstrated the sustained and superior performance of DCB compared to PTA through 36 months, with no difference in mortality through 48 months and sustained benefit seen in several subgroups.

Medtronic advised that the Kaplan-Meier estimated target lesion primary patency for several subgroups was reported through 36 months, demonstrating continued sustained effectiveness with DCB versus PTA as follows:

• Perianastomotic lesion location; 40.4% versus 31.1% (log-rank P = .047)
• Restenotic lesion type; 40.5% versus 22.7% (log-rank P <. 001)
• Forearm fistulas; 44.5% versus 33.8% (log-rank P = .039)
• Upper arm fistulas; 39.9% versus 21.3% (log-rank P = .011)

The Kaplan-Meier estimated cumulative incidence of all-cause mortality post vital status update through 48 months was 34.6% in the DCB group and 41.8% in the PTA control group (log-rank P = .42).

In August 2020, the initial results of the 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). The trial met both its primary safety and effectiveness endpoints—showing promise for the use of the In.Pact AV DCB to treat AV fistula lesions in patient with end-stage renal disease. Through 6 months, target lesion primary patency was 82.2% in the DCB group compared to 59.5% in the PTA group (log-rank P < .001). Additionally, there was a 56% reduction in reinterventions through 6 months.

Results have continued to demonstrate a durable and sustained treatment effect of the In.Pact AV DCB compared to PTA through 12 months, 24 months (presented at CXS in April 2021), and 36 months (presented at CXS in April 2022).

Recently published studies based on this data from the 12-month time point include the following:

• Clinical outcomes by Prof. Holden et al in Journal of Vascular and Interventional Radiology (2022;33:884-894)
• Economic outcomes by Jan B. Pietzsch, PhD, et al in Journal of Vascular and Interventional Radiology (2022;33:895-902)
• Economic outcomes focused on the Japanese and South Korean health care system by Ho Jong Chun, MD, et al in Nephrology (2022;27:859-868)
• Clinical outcomes of Japanese patients by Hiroaki Haruguchi, MD, et al online in Therapeutic Apheresis and Dialysis