September 14, 2020
Twenty-Four–Month Data Presented From AVeNEW Trial of BD’s Covera Vascular Covered Stent
September 14, 2020—BD announced that updated 24-month data from the AVeNEW trial were presented by principal investigator Bart Dolmatch, MD, at the Cardiovascular and Interventional Radiological Society of Europe’s CIRSE 2020 Summit held online September 12-15.
AVeNEW compared outcomes using the Covera vascular covered stent (BD) versus percutaneous transluminal angioplasty (PTA) for the treatment of stenotic lesions in the venous outflow of upper-extremity arteriovenous fistula (AVF).
The prospective, multicenter, concurrently controlled randomized trial was composed of 280 patients enrolled at 24 sites in the United States, Europe, Australia, and New Zealand. Patients in the trial were randomized to treatment with Covera (n = 141) and PTA (n = 138). Follow-up in the trial will continue through 3 years.
In discussing the trial with Endovascular Today, Dr. Dolmatch commented, “For most people with renal failure, an AVF is their lifeline for hemodialysis. But AVF’s often develop dysfunction due to stenosis. While PTA reliably produces a good immediate result, restenosis is common. The AVeNEW trial is the first prospective randomized clinical study of PTA versus covered stent to treat stenotic AVF’s.”
The Covera covered stent was designed to treat stenotic lesions in AV access circuits. It is available in both a flared and a straight configuration to allow for precise sizing and apposition to the vessel wall, and it includes an easy-to-use thumbwheel delivery system. BD announced FDA premarket approval of the Covera for patients with end-stage renal disease who are on hemodialysis in March 2019.
The trial’s primary safety endpoint was the 30-day event rate, which was noninferior for Covera versus PTA (95% vs 96.4%; P = .002).
In the primary efficacy endpoint of target lesion primary patency at 6 months, Covera was superior to PTA (78.7% vs 47.9%; P < .001).
Dr. Dolmatch reported freedom from loss of TLPP at 24 months was 41.8% for Covera versus 10.4% for PTA (P < .001). At 180 days, the rates were 78.7% versus 47.9%; at 365 days, the rates were 56.6% versus 21.2%.
Secondary outcomes in 199 of 280 (71.1%) patients available at 24-month follow-up for Covera versus PTA included secondary patency 91.4% versus 91.4%; index of patency function (µ [days] ± SD) of 224.0 ± 183.4 versus 179.9 ± 134.7; mean access circuit reinterventions (µ ± SD) of 3.1 ± 2.6 versus 3.6 ± 2.4; and all-cause death of 16.9% versus 23.2%.
The freedom from loss of access circuit primary patency at 24 months was 15.5% for Covera versus 9.3% for PTA alone (P = .02). The rates at 180 days were 50.7% versus 43.8% and at 365 days were 28.9% versus 17.7%, reported Dr. Dolmatch at CIRSE.