Medtronic's IN.PACT AV Access Trial Meets Primary Safety and Effectiveness Endpoints
Posted on September 07, 2019 by Medtech[y] Staff
Medtronic ($MDT) announced that the primary safety and effectiveness endpoints were met in the IN.PACT AV Access clinical study, which compares 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 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.
“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.”
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 56.0% 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 U.S. 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,” said 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 U.S., 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.