August 19, 2020
Results Published From Medtronic’s IN.PACT AV Access Trial
August 19, 2020—Medtronic announced that the primary endpoint results from the IN.PACT AV Access randomized controlled trial of the company's In.Pact AV drug-coated balloon (DCB) were published by Robert A. Lookstein, MD, et al in The New England Journal of Medicine (2020;383:733-742). The company noted that the In.Pact AV DCB, which is approved for the treatment of failing arteriovenous (AV) access, met both its primary safety and effectiveness endpoints.
According to Medtronic, the results reinforce that the In.Pact AV DCB limits the number of reinterventions needed to maintain patency in patients with end-stage renal disease (ESRD) who have AV fistula, leading to fewer interruptions to their dialysis therapy.
The trial enrolled 330 patients at 29 sites in the United States, Japan, and New Zealand, who were randomized to a group treated with the In.Pact AV DCB or to a control group treated with percutaneous transluminal angioplasty (PTA).
Through 6 months, the rate of target lesion primary patency was substantially higher in patients treated with In.Pact AV DCB than in the patients treated with PTA (82.2% vs 59.5%; P < .001).
Comparing the In.Pact DCB group versus the PTA control group, Kaplan-Meier estimates for this data set indicate:
- Primary patency of the target lesion rate at 180 days of 86.1% versus 68.9% (log-rank P < .001)
- Primary patency of the target lesion rate at 210 days of 81.4% versus 59% (log-rank P < .001)
Additionally, patients treated with In.Pact AV DCB required 56% fewer reinterventions to maintain lesion patency as compared with those treated with PTA through 6 months.
For the study’s primary safety endpoint, the In.Pact AV DCB group showed noninferiority versus the PTA control group in the rate of severe adverse events involving the AV access circuit within 30 days.
Through 12 months, the mortality rate was comparable between the In.Pact AV DCB group and the PTA control group (9.4% vs 9.6%; log-rank P = .931).
“The 6-month data demonstrate that with In.Pact AV DCB we can cut the number of reinterventions required to maintain vessel patency in half,” commented Dr. Lookstein,the study’s United States principal investigator, in Medtronic's press release. “This technology may positively impact patients’ quality of life and demonstrate meaningful reductions in projected costs to the health care system.”
Dr. Lookstein continued, “Right now, this is very important for ESRD patients on hemodialysis, who are at especially high risk of acquired infections. This technology may have the potential to allow these patients to experience continued, uninterrupted access to life-saving dialysis care, including fewer hospital visits to get their access sites maintained.” Dr. Lookstein is Professor of Radiology and Surgery, Executive Vice-Chair in the Department of Diagnostic, Molecular, and Interventional Radiology at the Icahn School of Medicine at Mount Sinai in New York, New York.
Terry Litchfield, President of Access Solutions, an organization focused on patient advocacy related to vascular access services, stated in Medtronic’s announcement, “When treated with standard PTA, ESRD patients requiring AV fistula maintenance often have to undergo anywhere from one to three access procedures per year. This, in addition to their multiple weekly dialysis appointments, results in even more time spent in a health care setting. These newly published data on In.Pact AV DCB not only show promise in keeping people living with ESRD out of the hospital for longer, they also demonstrate that using this DCB will reduce the number of interventions a patient will need each year, thus avoiding the time and expense of additional procedures to keep their dialysis access working well.”
The first results from the IN.PACT AV Access clinical study were presented at CIRSE 2019, the annual conference of the Cardiovascular and Interventional Radiology Society of Europe held September 7-11 in Barcelona, Spain.
In November 2019, Medtronic announced FDA approval of the In.Pact AV DCB indicated for the treatment of failing AV access in patients with ESRD undergoing dialysis. In Europe, the CE Mark-approved indication for the company’s In.Pact Admiral DCB was expanded for the treatment of failing AV access in patients with ESRD undergoing dialysis in January 2015.