Twelve-Month Data From VIRTUS Trial Presented for Boston Scientific's Vici Venous Stent
January 22, 2019–Boston Scientific Corporation announced 12-month data demonstrating a high rate of patent target lesions in patients treated with the company's Vici venous stent system for iliac and femoral vein obstructions. Primary safety and efficacy results from the VIRTUS trial were presented as a first-time data release at LINC 2019, the Leipzig Interventional Course held January 22–25 in Leipzig, Germany.
The VIRTUS investigational device exemption trial is a prospective, multicenter, single-arm, nonrandomized study of the Vici stent. The trial is composed of 170 patients with chronic disease—75% of whom were diagnosed with clinically significant obstructions in the illiofemoral venous outflow tract resulting from postthrombotic syndrome and 25% of whom were diagnosed with nonthrombotic lesions (ie, May-Thurner syndrome).
In the VIRTUS trial, the Vici stent met its primary effectiveness endpoint with a primary patency rate of 84% at 12 months, which was greater than the predefined performance goal of 72.1% (P ≤ .0001). Nearly all of the patients treated with the Vici stent (98.8%) were free from major adverse events at 30 days postprocedure, which surpasses the predefined safety performance goal of 94%.
In Boston Scientific's announcement, Mahmood Razavi, MD, commented, "In treating patients with venous obstruction, the primary goal is to restore and maintain vessel patency to ensure the return of blood flow to the heart. In these results, the Vici stent demonstrated excellent performance outcomes in a difficult-to-treat patient population, which translates to improvement of long-term symptoms and enhanced quality of life in these patients." Dr. Razavi is Principal Investigator of the VIRTUS trial and Director of the Department of Clinical Trials at St. Joseph Hospital Heart and Vascular Center in Orange, California.
The Vici stent system received European CE Mark approval in 2013. In the United States, the Vici system is an investigational device and is not available for sale. The device was developed by Veniti Inc., which Boston Scientific acquired in August 2018.