Medtronic (NYSE:MDT) recently announced the results of a study showing that some kidney disease patients who had a drug-coated balloon (DCB) implanted to treat arteriovenous (AV) failure experienced fewer interruptions of dialysis treatment.
Many end-stage renal disease (ESRD) patients require AV fistulae in order to receive continuous dialysis. Blood vessels that feed the access site can narrow over time and patients often undergo multiple maintenance procedures per year to restore access site function. The need for frequent reinterventions can result in repeated hospital visits and significant disruptions to hemodialysis care. By being able to maintain access site patency, patients may experience longer periods of uninterrupted dialysis, according to a news release from Medtronic.
The IN.PACT AV Access trial followed 330 patients at 29 sites in U.S., Japan, and New Zealand. Six-month, primary endpoint results showed the number of blood vessel reinterventions to maintain patency was cut in half in patients treated with the In.Pact paclitaxel-coated balloon. Specifically, the rate of target lesion primary patency was 82.2% in participants treated in the In.Pact arteriovenous DCB group compared to 59.5% in the percutaneous transluminal angioplasty (PTA) control group. Results were published in the New England Journal of Medicine.
“This technology may positively impact patients’ quality of life, and demonstrate meaningful reductions in projected costs to the healthcare system,” said U.S. study principal investigator Dr. Robert Lookstein, a professor of radiology and surgery at the Icahn School of Medicine at Mount Sinai in New York. “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.”
For its primary safety endpoint, the In.Pact AV DCB group showed non-inferiority versus the PTA control group in the rate of severe adverse events involving the AV access circuit within 30 days, Medtronic reported. 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=0.931).
“When treated with standard PTA, ESRD patients requiring AV fistula maintenance often have to undergo anywhere from 1 to 3 access procedures per year. This, in addition to their multiple weekly dialysis appointments, results in even more time spent in a healthcare setting,” said Terry Litchfield, president of Access Solutions, a vascular access patient advocacy group. “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.