Medtronic recently announced the safety and effectiveness results through 24 months for the IN.PACT AV Access clinical study. The data, which were presented virtually as a Podium 1st at the Charing Cross (CX) 2021 Digital Edition (19–22 April, online) demonstrated that the IN.PACT AV drug-coated balloon (DCB) is the first and only DCB to show sustained and superior effectiveness through two years compared to standard percutaneous transluminal angioplasty (PTA) in end-stage renal disease (ESRD) patients with de novo or non-stented restenotic native arteriovenous fistulae (AVF) in the upper extremity.
“A patient who receives haemodialysis will often need to have several reinterventions each year to maintain patency and keep critical access sites open and functioning properly,” said Andrew Holden (Auckland Hospital and Auckland University, Auckland, New Zealand), who presented the results at CX 2021. “Being able to show these results at two 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.”
Over two years, the IN.PACT AV DCB group demonstrated a continued clinical benefit compared to the PTA control group. Key data highlights per Kaplan-Meier estimates for this dataset include:
- Target lesion primary patency through 24 months was 52.2% in the IN.PACT AV DCB group compared to 36.2% in the PTA control group (log-rank p<0.001).
- Access circuit primary patency through 24 months was 39.5% in the IN.PACT AV DCB group compared to 25.4% in the PTA control group (log-rank p<0.001).
- Freedom from all-cause mortality through 24 months was 82.4% in the IN.PACT AV DCB study group and 82.8% in the PTA control group (log-rank p=0.829).
About the IN.PACT AV Access study
The IN.PACT AV Access study is a prospective, global, single-blinded, randomised controlled trial, which enrolled 330 patients at 29 sites in the USA, Japan, and New Zealand. Results of the six-month pivotal IN.PACT AV Access study were presented at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting in 2019 (7–11 September, Barcelona, Spain) and also published in The New England Journal of Medicine in August 2020.