Bart Dolmatch (Portola Valley, USA) talks to Vascular News about some of the key data highlights from the 24-month AVeNEW trial, which compared the safety and efficacy of the Covera™ Vascular covered stent (BD) against percutaneous transluminal angioplasty (PTA) for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous access circuit.
The data, which was presented at CIRSE 2020, are “very compelling”, says Dolmatch, who notes that that the primary endpoints of safety at one-month and durability at six-months were “superior” for the covered stent compared to angioplasty alone. These results “hold up” at 24-months, he adds, with a greater target lesion primary patency for the covered stent group (N=69) compared to the PTA group (N=25), 41.8% vs. 10.4% respectively – highlighting a “dramatic improvement” at the target lesion site.
He also discusses the importance of circuit patency when treating hemodialysis patients, stating that there is now “robust data” to show that the use of the Covera™ Vascular covered stent is a “great strategy” for cephalic vein arch stenosis. Further sub-analyses showed that the Covera™ Vascular covered stent performed better regardless of the type of arteriovenous fistula, lesion location, de novo or recurrent lesions, concluded Dolmatch.
This video is sponsored by BD
Indication For Use: The Covera™ Vascular Covered Stent is indicated for use in hemodialysis patients for the treatment of stenoses in the venous outflow of an arterio-venous (AV) fistula and at the venous anastomosis of an ePTFE or other synthetic AV graft.
Warnings: DO NOT use in patients with known hypersensitivity to nickel-titanium or tantalum. · Placing a covered stent across a vessel side branch may impede blood flow and hinder or prevent future procedures. · DO NOT place a flared covered stent with the flared end in a straight vessel segment since this may lead to flow turbulences. · Covered stent placement beyond the ostium of the cephalic vein into the axillary/subclavian vein may hinder or prevent future access.
Potential Complications and Adverse Events: Complications and Adverse Events associated with the use of the Covera™ Vascular Covered Stent may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions.
Please consult product labels and package inserts for indications, contraindications, hazards, warnings, cautions, and information for use.