VIRTUS: Two-Year Data on Venous Stent “Excellent”

by Debra L. Beck

Hollywood, FL (January 23, 2020) – Two-year findings from the VIRTUS trial of the VICI venous stent (Boston Scientific) showed a primary patency rate of 79.4%. As has been seen in other trials, primary patency was higher in non-thrombotic lesions (94.6%) as compared to post-thrombotic lesions (73.4%).  

“This is an excellent device, excellent performance, in a particularly challenging lesion subset, with continuing durable benefit even in chronic post-thrombotic cases out to twenty-four months follow-up,” reported Robert Lookstein, MD, from the Mount Sinai Health System in New York, NY.

There were no procedure or device-related deaths and no reports of stent movement. The rate of target vessel revascularization, including target-lesion and non-target lesion revascularization, was 11.3% at 2 years. 

VICI is one of two dedicated venous stents to recently receive FDA approval (May 2019), the other being the Venovo stent (BD) approved in early 2019. The VICI approval was based on one-year data from VIRTUS presented at ISET 2019, which showed a primary patency rate of 84%, handily exceeding the performance goal of 72.1% (P<0.001).

As previously reported, the venous clinical severity score (VCSS) declined from a mean of 10 at baseline to 5.6 at 12 months, with 64% of patients demonstrating at least a 3-point reduction in VCCS at 12 months.

Twelve-month safety and efficacy data from VIRTUS published in December in Circulation: Cardiovascular Interventions (Razavi et al. 2019;Dec 13.)

VIRTUS enrolled 170 patients (mean age, 54.4 years; 43.5% male) with obstruction of the iliofemoral venous outflow tract. Participants were prospectively enrolled at 22 sites to undergo endovenous stent placement with the VICI stent. The majority (76.5%) had post-thrombotic disease.

“This is the only FDA-approved close-cell design for the iliofemoral segment, and I think the primary patency out to two years should be well embraced for its ability to maintain patency for symptomatic patients with complex lesions,” said Dr. Lookstein.