New real-world data from the IN.PACT AV Access post-approval study, demonstrating strong safety and effectiveness outcomes for the IN.PACT AV drug-coated balloon (DCB, Medtronic) in the treatment of arteriovenous fistula (AVF) stenoses in patients with end-stage kidney disease (ESKD) on dialysis.
The 12-month outcomes were presented in a late-breaking session at the Society of Interventional Radiology (SIR) annual scientific meeting (11–15 April, Toronto, USA). A study intended to expand real-world experience, the prospective, multicentre study evaluated the IN.PACT AV DCB across 17 US clinical sites, with independent core laboratory and clinical events committee oversight.
The post‑approval study was designed as a confirmatory extension of the pivotal randomised controlled trial of the device—further strengthening the evidence base by evaluating performance in a real‑world AV access population with high comorbidity burden, Medtronic states in a press release.
“Real-world evidence is essential to understanding how therapies perform outside of controlled trial settings,” said Sanjay Misra (Mayo Clinic, Rochester, USA), principal investigator of the study, was quoted as saying. “The IN.PACT AV post-approval study provides important confirmation that drug-coated balloon treatment can deliver consistent, safe outcomes for AV fistula maintenance in everyday clinical practice in this complex dialysis population.”
Key, 12-month findings demonstrated that most treated AV fistulas were brachiocephalic (51.6%), followed by brachiobasilic (20.8%) and radiocephalic (20.8%); the most common lesion locations were the cephalic arch (25.8%) and venous outflow (25.2%), and lesions were de novo (59.5%) or non-stented restenotic (40.5%).
Target lesion primary patency at 12 months was 70.2% and access circuit primary patency at 12 months was 52.6%. Target lesion and access circuit patency rates were aligned with the 12-month outcomes observed for the IN.PACT AV DCB in the pivotal randomised trial (65.3%, 55.1%, respectively) and better than percutaneous transluminal angioplasty (PTA) rates (46.3%, 35%, respectively).
Fewer than one reintervention per patient was required through 12 months, which is below the average of 1.5 reintervention procedures per year. The serious infection rate at 12 months was 13.4%, below literature reports ranging from 19–23%
“These strong real-world data are an important contribution to the body of clinical data supporting the role of the IN.PACT AV DCB for AV fistula maintenance,” said David Moeller, SVP and president of Peripheral Vascular Health, which is part of the Cardiovascular Portfolio at Medtronic. “We are proud to lead the industry in generating long term clinical evidence in this space and grateful to improve durable AV fistula patency for patients with ESKD requiring dialysis, reducing their need for reinterventions.”
