Medtronic has 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 (7–11 September, 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,” says Andrew Holden, director of interventional radiology at Auckland Hospital and associate professor of radiology at Auckland University (Auckland, New Zealand). “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 haemodialysis 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. The need for frequent reinterventions can result in significant disruptions to critical haemodialysis 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 maximising a patient’s uninterrupted access to lifesaving dialysis care.
The IN.PACT AV Access study is a randomised controlled trial (RCT), which has enrolled 330 subjects at 29 sites in the USA, Japan, and New Zealand. The primary effectiveness endpoint was defined as freedom from clinically-driven target lesion revascularisation (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 revascularisations, 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<0.001).
- Per Kaplan-Meier estimates, the primary patency rate of the target lesion at 210 days was 81.4% in the IN.PACT AV DCB group compared to 59.0% in the PTA control group (p<0.001).
- Patients in the IN.PACT AV DCB group required 56% fewer reinterventions to maintain target lesion patency through 210 days compared to those in the PTA control group
- A low rate of access circuit-related serious adverse events, with 4.2% in the IN.PACT AV DCB study group compared to 4.4% in the PTA control group through 30 days.
Additionally, the Kaplan-Meier estimated freedom from all-cause death through 360 days was 90.6% in the IN.PACT AV DCB study group and 90.4% in the PTA control group. This data adds to the initial safety data presented at US Food and Drug Administration’s Advisory Committee meeting of the Circulatory System Devices Panel in June, showing no difference in mortality rates in this patient population.
“The data presented today at CIRSE demonstrate the potential of IN.PACT AV DCB to address restenosis in high-risk patients who currently have few long-term treatment options available to them,” comments Mark Pacyna, vice president and general manager of the Peripheral Vascular business, which is part of the Aortic, Peripheral, and Venous division at Medtronic. “As part of our commitment to improving outcomes, we look forward to generating further clinical evidence in support of this therapy.”
In the USA, IN.PACT AV DCB is an investigational device and not yet approved for commercial use. In January 2016, the CE (Conformité Européene) indication for the IN.PACT Admiral DCB was expanded for the treatment of failing arteriovenous access in patients with end-stage renal disease undergoing dialysis.
In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.