Medtronic’s In.Pact AV and In.Pact Admiral Devices Evaluated in Subset Data Presented at CIRSE

September 29, 2021—Medtronic announced the presentation of new subset data for its In.Pact AV paclitaxel drug-coated balloon (DCB) for arteriovenous (AV) access maintenance and for its In.Pact Admiral paclitaxel-coated percutaneous transluminal angioplasty (PTA) catheter. The presentations were made on September 28 in recorded sessions at the virtual CIRSE 2021 Summit, the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe held online September 25-28.

Andrew Holden, MBChB, presented 24-month outcomes by demographic subsets in the IN.PACT AV Access study, which is evaluating the In.Pact AV DCB to treat AV fistula lesions in end-stage renal disease patients. Dr. Holden reported the target lesion primary patency outcomes in males and females, as well as race and ethnic subgroups.

Professor Marianne Brodmann, MD, presented the 5-year results from the IN.PACT Global Study gender and diabetic subgroups in a livestreamed “First@CIRSE–New Frontiers” session.

As summarized by Medtronic, the IN.PACT AV Access subgroup findings included the following:

• Through 24 months, sustained superior target lesion primary patency was achieved with In.Pact AV DCB in men; Black, African American, or Asian patients; and those of non-Hispanic/Latino ethnicity.
• Benefits were seen in all other subgroups, including women, although sample sizes were small, and the treatment effect was not statistically significant.
• An additional time-to-event analysis demonstrated a 15+ month delay in the loss of target lesion primary patency between groups treated with DCB compared to PTA.

These demographic subset outcomes are an important addition to the clinical landscape and the practice of evidence-based medicine for patients at high risk of repeat interventions, noted Medtronic.

In the presentation of the IN.PACT Global Study gender and diabetic subgroups data, Prof. Brodmann concluded, “5-year real-world data from the IN.PACT Global Study continue to confirm the safety and effectiveness of the In.Pact Admiral paclitaxel-coated PTA catheter in females and diabetics.”

Medtronic summarized the findings from the gender cohort as follows:

• The 5-year Kaplan-Meier freedom from clinically driven target lesion revascularization (CD-TLR) rate was 69.1% for the females versus 69.6% for the males (log-rank P = .602).
• The 5-year Kaplan-Meier freedom from all-cause death after vital status update (96.4% vital status follow-up) was 76.9% for the females versus 79.9% for the males (log-rank P = .229).
• Low major target limb amputation cumulative incidence through 5 years was in both females and males (Kaplan-Meier estimate of 1.4% in the females and 1.8% in the males; log-rank P = .596).

The diabetic cohort data included the following:

• The 5-year Kaplan-Meier freedom from CD-TLR rate was 70.5% in the nondiabetic group versus 67.7% in the diabetic group (log-rank P = .246).
• The 5-year Kaplan-Meier freedom from all-cause death after vital status update (96.4% vital status follow-up) was 81.4% in the nondiabetic group versus 75.3% in the diabetic group (log-rank P = .004).
• There was low major target limb amputation cumulative incidence through 5 years in both the nondiabetic and diabetic group (Kaplan-Meier estimate of 1.1% in the nondiabetic and 2.5% in the diabetic; log-rank P = .085).