VIVO: Venous stent safe, effective at 3 years
Click Here to Manage Email Alerts
In patients with symptomatic iliofemoral venous outflow obstruction, a venous stent was safe and effective at 3 years, according to results of the VIVO trial presented at VIVA 21.
The prospective, single-arm trial included 243 patients (mean age, 53 years; 70% women) in the U.S. and Taiwan who received the venous self-expanding stent (Zilver Vena, Cook Medical) to treat symptomatic iliofemoral venous outflow obstruction (30% acute).
The stent “is designed for treating iliac and common femoral venous outflow tract obstruction that is symptomatic,” Paul J. Gagne, MD, FACS, RVT, founder and lead physician of Vascular Care Connecticut in Darien, said during a presentation. “The VIVO study was the IDE trial for its safety and effectiveness.”
Among the cohort, 43% had postthrombotic syndrome and 24% had acute deep vein thrombosis, Gagne said. In addition, he said, 32.5% had stent extension below the inguinal ligament.
Previously reported data showed that the stent met the primary effectiveness endpoint of 30-day freedom from major adverse events and the primary safety endpoint of 12-month primary quantitative patency, Gagne said.
At 3 years, the rate of freedom from clinically driven reintervention was 92.6% (compared with 95.8% at 1 year) and the rate of freedom from any reintervention was 82.9% (compared with 89.9% at 1 year), he said.
The rate of patency as assessed by ultrasound was 90.3% compared with 92.5% at 1 year, Gagne said.
The mean change in Venous Clinical Severity Score was significant at 1 month (P < .0001) and sustained through 3 years, Gagne said, noting that at 3 years, the score declined by 4.2 points from baseline (95% CI, –4.6 to –3.5).
The Venous Disability Score improved at 3 years, as did the Clinical-Etiological-Anatomical-Pathophysiological “C” classification (P < .0001 for both), he said, noting that improvements were observed as early as 1 month.
The Chronic Venous Insufficiency Quality of Life Questionnaire score improved at 1 month and 3 years (P < .0001), and at 3 years, the mean decrease was 20.8 points (95% CI, –24.8 to –16.8), Gagne said.
There were no cases of stent fracture, he said.
“The VIVO clinical study included a real-world population, with a significant number of patients with acute DVT and postthrombotic disease, as well as compression lesions,” Gagne said during the presentation. “The results through 3 years support the continued safety and effectiveness of the Zilver Vena stent for the treatment of symptomatic iliac and common femoral vein disease.”
Collapse
Gagne PJ, et al. Late-Breaking Clinical Trials. Presented at: VIVA 21; Oct. 4-7, 2021; Las Vegas (hybrid meeting).
Click Here to Manage Email Alerts