IN.PACT AV Access study of IN.PACT drug-coated balloon meets primary endpoints in patients with end-stage renal disease

Medtronic announced the first-ever results from the IN.PACT AV Access clinical study comparing the investigational IN.PACT AV drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) in patients with de novo or non-stented restenotic arteriovenous (AV) fistulae lesions. The study met primary safety and effectiveness endpoints. The IN.PACT AV Access study is a randomized controlled trial (RCT), which has enrolled 330 subjects at 29 sites in United States, Japan, and New Zealand. The primary effectiveness endpoint was defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through six months post-procedure and the primary safety endpoint was defined as the serious adverse event rate involving the AV Access circuit through 30 days post-procedure.

Overall, the IN.PACT AV DCB group demonstrated clinical benefit compared to the PTA control group. Key data highlights include: Per Kaplan-Meier estimates, the primary patency rate of the target lesion at 180 days was 86.1% in the IN.PACT AV DCB group compared to 68.9% in the PTA control group. Per Kaplan-Meier estimates, the primary patency rate of the target lesion at 210 days was 81.4% in the IN.PACT AV DCB group compared to 59.0% in the PTA control group. Patients in the IN.PACT AV DCB group required 56.0% fewer reinterventions to maintain target lesion patency through 210 days compared to those in the PTA control group. A low rate of access circuit-related serious adverse events, with 4.2% in the IN.PACT AV DCB study group compared to 4.4% in the PTA control group through 30 days. Additionally, the Kaplan-Meier estimated freedom from all-cause death through 360 days was 90.6% in the IN.PACT AV DCB study group and 90.4% in the PTA control group.

This data adds to the initial safety data presented at the FDA's Advisory Committee meeting of the Circulatory System Devices Panel in June, showing no difference in mortality rates in this patient population. AV fistulae, otherwise known as AV access sites, are created and used to deliver hemodialysis to patients with end-stage renal disease (ESRD). Over time, vessel restenosis limits the ability to use AV fistulae effectively. Data were presented at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting.