IN.PACT AV Drug-Coated Balloon Shows Promise in Treating Arteriovenous Fistulae Lesions in End-Stage Renal Disease Patients
DUBLIN and BARCELONA, Spain, Sept. 07, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) announced the first-ever results from the IN.PACT AV Access clinical study comparing the investigational IN.PACT™ AV™ drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) in patients with de novo or non-stented restenotic arteriovenous (AV) fistulae lesions. The study met primary safety and effectiveness endpoints and data were presented today at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting in Barcelona, Spain.
“Maintaining patency and limiting the frequency of reinterventions needed to keep AV access sites functioning properly remain significant treatment challenges for physicians treating AV fistulae lesions,” said Andrew Holden, M.D., director of interventional radiology at Auckland Hospital and associate professor of radiology at Auckland University. “These results demonstrate the promise of IN.PACT AV DCB to not only address these critical issues, but to potentially improve the quality of life of patients undergoing dialysis.”
AV fistulae, otherwise known as AV access sites, are created and used to deliver hemodialysis to patients with end-stage renal disease (ESRD). Over time, vessel restenosis limits the ability to use AV fistulae effectively. In order to restore function, patients often undergo one to three AV fistula maintenance procedures per year.1 The need for frequent reinterventions can result in significant disruptions to critical hemodialysis care and increased costs to the healthcare system. Drug-coated balloons have the potential to extend the time between reinterventions by maintaining AV access site patency, therefore maximizing a patient’s uninterrupted access to lifesaving dialysis care.
The IN.PACT AV Access study is a randomized controlled trial (RCT), which has enrolled 330 subjects at 29 sites in United States, Japan, and New Zealand. The primary effectiveness endpoint was defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through six months post-procedure and the primary safety endpoint was defined as the serious adverse event rate involving the AV Access circuit through 30 days post-procedure. Additional endpoints include but are not limited to: access circuit primary patency, cumulative target lesion revascularizations, and number of interventions required to maintain target lesion patency.
The study enrolled a challenging patient population who had been undergoing dialysis for an average of 4.3 years. Overall, the IN.PACT AV DCB group demonstrated clinical benefit compared to the PTA control group. Key data highlights include:
- Per Kaplan-Meier estimates, the primary patency rate of the target lesion at 180 days was 86.1% in the IN.PACT AV DCB group compared to 68.9% in the PTA control group (p