Three-year results of the VIVO clinical study support the continued safety and effectiveness of the Zilver Vena venous stent (Cook Medical) in the treatment of symptomatic iliofemoral venous outflow obstruction, attendees at the Vascular Interventional Advances (VIVA) 2021 (Oct. 5–7) in Las Vegas.
Paul Gagne, MD, a vascular surgeon and an associate clinical professor of surgery at New York University’s School of Medicine, presented the new data during a late-breaking session. “There are high rates of freedom from clinically driven reintervention, high rates of patency out to three years [by ultrasound], sustained clinical improvement in the patients’ response as scored by VCSS [Venous Clinical Severity Score], VDS [vascular duplex scan], CIVIQ [Chronic Venous Insufficiency Questionnaire] and change in CEAP [Clinical, etiology, anatomy, pathophysiology] ‘C,'” he told the gathering.
“In spite of a significant number of patients in this study who had extension under the inguinal ligament, no stent fractures have been identified by core lab evaluation.”
Patients with symptomatic obstruction of one iliofemoral venous segment were enrolled—those with a CEAP clinical classification ≥3 or VCSS pain score ≥2. Follow-up through three years included measures of patency, reintervention, clinical outcomes (measured by VCSS, VDS, CEAP “C,” and CIVIQ), and device integrity measures of fracture and migration.
The VIVO study enrolled 243 patients (70% female; mean age, 53±15 years; 67.5% with current or past deep vein thrombosis). The 30-day primary safety endpoint and 12-month primary effectiveness endpoint were met, exceeding the corresponding performance goals (p<0.0001), and improvement in clinical outcome measures was demonstrated at 12 months (p<0.0001).
Follow-up through three years is complete, Gagne told VIVA attendees, reporting that results observed at 12 months were maintained. Specifically, three-year outcomes include high rates of patency by ultrasound (90.3±2.2%), freedom from clinically-driven reinterventions (92.6± 2%), and freedom from reinterventions (82.9±2.6%). Clinical improvement, as measured by VCSS, VDS, CEAP “C”, and CIVIQ, was sustained through three years (p<0.0001).
There were no core lab-reported stent fractures, and only one core lab-reported migration (adjudicated as technique-related due to device undersizing) through three years.
Session moderator Niten Singh, MD, associate chief of vascular surgery at UW Medicine in Seattle, commented: “It’s nice to see a venous stent with some longer-term outcomes being successful.”