Final 3-Year VIVO Outcomes: Zilver Vena Venous Stent in Symptomatic Iliofemoral Venous Outflow Obstruction

The real-world safety and effectiveness of the Zilver Vena venous stent (Cook Medical) for the treatment of patients with symptomatic iliofemoral venous outflow obstruction were shown in the 3-year findings of the VIVO trial, presented at ISET 2022 by Anthony J. Comerota, MD, from the Inova Heart and Vascular Institute in Alexandria, Virginia.

The device is a self-expanding stent designed for the iliofemoral vein segment. It is currently available in more than 40 countries, including the US, EU, and China.

VIVO was a prospective, multicenter, single-arm trial that enrolled 243 patients (mean age, 53 years; 70% women; 67.5% with current or past deep vein thrombosis) in the US and Taiwan. Eligible participants had symptomatic outflow obstruction of one iliofemoral venous segment, (CEAP “C” [clinical] classification ≥ 3 or VCSS pain score ≥ 2).

Thirty percent of patients were presented with acute symptom onset of 30 days or less, and the remaining were considered chronic (symptom onset ³ 30 days). The mean lesion length was approximately 10 centimeters, and 22.3% of the patients presented with total occlusion of their iliac veins, said Dr. Comerota.

The primary safety endpoint was 30-day freedom from major adverse events, and the primary effectiveness endpoint was primary quantitative patency as assessed by venography at 12 months. Both endpoints were met, exceeding the corresponding performance goals (P<.0001).

Specifically, 3-year outcomes include high rates of freedom from clinically driven reintervention and freedom from any reintervention (see slide below).

In addition, patency by ultrasound at 3 years was 90.3% and clinical improvement, as measured by VCSS, VDS, change in CEAP “C”, and CIVIQ, was sustained through 3 years (P<.0001).

Importantly, there were no core laboratory-reported stent fractures, and only one core laboratory-reported migration (adjudicated as technique-related caused by device undersizing) through 3 years, as noted in the VIVA announcement.

“There was only one clinical migration, and that was adjudicated as a technical error in terms of undersizing of the stent,” reported Comerota. Core laboratory review of imaging identified no fractures through 3 years, “and that includes the 79 stents that had stents extended under the inguinal ligament,” he added.