VERNACULAR: Venous stent patent, improves pain, comfort at 3 years
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A venous stent was associated with improvement in pain and patient comfort while achieving patency for approximately 80% of patients at 3 years, researchers reported at the International Symposium on Endovascular Therapy.
As Healio previously reported, the stent (Venovo, BD) was associated with favorable outcomes at 1 year and at 2 years in the single-arm VERNACULAR study. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM, professor of radiology and surgery at Icahn School of Medicine at Mount Sinai and executive vice chairman in the department of diagnostic, molecular and interventional radiology for the Mount Sinai Health System, presented the 3-year results, which were published in Cardiovascular and Interventional Radiology.
“The stent is a self-expanding, open-cell nitinol stent,” Lookstein said during the presentation. “What is unique about this particular implant is the flared ends, which are designed to promote more uniform wall apposition and to prevent migration,” Lookstein said during the presentation.
The study included 170 patients (mean age, 52 years; 63% women) who had symptomatic venous outflow obstruction of at least 50% in the iliac and femoral veins.
At 3 years, the Kaplan-Meier estimate of primary patency was 84% (95% CI, 78.2-88.3; P vs. historical control < .0001), Lookstein said during the presentation.
The pain score from the Venous Clinical Severity Score averaged 2.2 at baseline but improved to 0.4 at 3 years (difference, –1.8; 95% CI, –1.95 to –1.66; P < .0001), he said, noting the change was consistent between those who had post-thrombotic syndrome and those who had nonthrombotic iliac vein lesions.
The Chronic Venous Disease Quality of Life Questionnaire score improved from 49.7 at baseline to 31.3 at 3 years (difference, –16.8; 95% CI, –20.07 to –13.54; P < .0001), and there was similar improvement in the post-thrombotic syndrome group and the nonthrombotic iliac vein lesion group, he said.
At 3 years, the rate of freedom from target lesion revascularization in the intention-to-treat population was 88.1% (95% CI, 81.8-92.8), the weighted primary patency rate in the intention-to-treat population was 79.5% (90% CI, 72.4-85.4) and there were no stent fractures, Lookstein said.
“The use of the Venovo venous stent to treat iliofemoral vein obstructions demonstrated excellent primary patency as compared to the objective performance goal,” Lookstein said. “The [pain] and quality of life scores improved immediately at 30 days and persisted, demonstrating the clinical efficacy, at the 3-year follow-up period.”
Reference:
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Lookstein R, et al. Late-Breaking Data and Hot Topics. Presented at: International Symposium on Endovascular Therapy; Jan. 16-19, 2022; Hollywood, Florida (virtual meeting).
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