2-Year Results Presented From Medtronic’s IN.PACT AV Access Trial

April 20, 2021—Medtronic announced that the safety and effectiveness results through 24 months for the IN.PACT AV Access clinical study were presented virtually at the 2021 Charing Cross Symposium.

According to Medtronic, the prospective, global, single-blinded, randomized controlled trial enrolled 330 patients at 29 sites in the United States, Japan, and New Zealand.

In the study, the company’s In.Pact AV drug-coated balloon (DCB) showed sustained and superior effectiveness through 2 years compared to standard percutaneous transluminal angioplasty (PTA) in patients with end-stage renal disease with de novo or nonstented restenotic native arteriovenous (AV) fistula in the upper extremity.

“A patient who receives hemodialysis will often need to have several reinterventions each year to maintain patency and keep critical access sites open and functioning properly,” commented Andrew Holden, MBChB, in the company’s announcement. “Being able to show these results at 2 years will ultimately impact standard of care for patients undergoing dialysis. For my patients, these durable results translate into fewer reinterventions and a better quality of life.” Dr. Holden is Director of Interventional Radiology at Auckland Hospital and Associate Professor of Radiology at Auckland University in Auckland, New Zealand.

Key data highlights per Kaplan-Meier estimates for this data set through 24 months for the In.Pact AV DCB versus the PTA control group include:

• Target lesion primary patency of 52.2% versus 36.2% (log-rank P < .001)
• Access circuit primary patency of 39.5% versus 25.4% (log-rank P < .001)
• Freedom from all-cause mortality of 82.4% versus 82.8% (log-rank P = .829)

In August 2020, the 6-month primary endpoint results from the IN.PACT AV Access trial were published by Robert A. Lookstein, MD, et al in The New England Journal of Medicine (2020;383:733-742).