Medtronic has announced new randomised controlled data demonstrating the sustained and superior performance of the IN.PACT AV drug-coated balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) through 36 months, with no difference in mortality. The data were delivered as a Podium 1st presentation at the 2022 Charing Cross (CX) Symposium (26–28 April; London, UK).
“The 36-month data from the IN.PACT AV Access study validate 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 (Auckland University School of Medicine, Auckland, New Zealand). “As the only pivotal DCB study in arteriovenous access to meet its primary effectiveness endpoint, the IN.PACT AV DCB has shown unrivalled long-term clinical benefits that support its use as the standard of care for AVF [arteriovenous fistula] maintenance in patients with end-stage kidney disease.”
As vessel restenosis limits the ability to use fistulas effectively over time, patients often undergo up to three AVF maintenance procedures per year to restore function. The need for frequent reinterventions can result in significant disruptions to critical haemodialysis care and increased costs to the healthcare system, according to a Medtronic press release.
The IN.PACT AV Access study’s three-year data further demonstrate the ability for the IN.PACT AV DCB to extend time to reinterventions from the index procedure by maintaining access site patency, therefore maximising 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).
“Medtronic is committed to bringing forward technologies that improve the lives of patients undergoing dialysis,” said David Moeller, president of the Peripheral Vascular Health business, which is part of the Cardiovascular Portfolio at Medtronic. “These results demonstrate IN.PACT AV DCB’s ability to significantly reduce the number of reinterventions, as well as the potential to reduce comprehensive care costs.”
A full presentation of these data by Andrew Holden can be viewed online here.