New randomized controlled data demonstrating the sustained and superior performance of IN.PACT AV drug-coated balloons (DCBs) compared to percutaneous transluminal angioplasty (PTA) through 36 months, with no difference in mortality, was revealed during a Podium 1st presentation at the 2022 Charing Cross (CX) Symposium in London, England, Medtronic announced.
“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,” said Andrew Holden, MBChB, director of interventional radiology and associate professor of radiology, Auckland University School of Medicine, Auckland, New Zealand. “As the only pivotal DCB study in arteriovenous (AV) access to meet its primary effectiveness endpoint, the IN.PACT AV DCB has shown unrivaled long-term clinical benefits that support its use as the standard of care for AV fistula maintenance in patients with end-stage kidney disease.”
As vessel restenosis limits the ability to use AV fistulas effectively over time, patients often undergo up to three AV fistula maintenance procedures per year to restore function. The need for frequent reinterventions can result in significant disruptions to critical hemodialysis care and increased costs to the healthcare system.
The IN.PACT AV Access study’s three-year data further demonstrates 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. Over three years, the IN.PACT AV DCB group demonstrated a continued clinical benefit compared to the PTA control group. Key highlights for this dataset include:
The Kaplan-Meier estimated target lesion primary patency through 36 months was 43.1% in the IN.PACT AV DCB group compared to 28.6% in the PTA control group (log-rank p<0.001). The Kaplan-Meier estimated access circuit primary patency through 36 months was 26.4% in the IN.PACT AV DCB group compared to 16.6% in the PTA control group (log-rank p<0.001).
The Kaplan-Meier estimated cumulative incidence of all-cause mortality post-vital status update through 36 months was 26.6% in the IN.PACT AV DCB group and 30.8% in the PTA control group (log-rank p=0.709).