Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction

• DOI: 10.1007/s00270-021-02975-2
• Publication Date: 2021-09-20T16:31:03Z
• Authors: Michael D. Dake; Gerard O’Sullivan; Nicolas W. Shammas; Michael Lichtenberg; Bibombe P. Mwipatayi; Richard A. Settlage
• Keywords: May–Thurner syndrome

Abstract Purpose To assess safety and patency of the Venovo venous stent for treatment iliofemoral vein obstruction. Materials Methods Twenty-two international centers enrolled 170 patients in VERNACULAR study (93 post-thrombotic syndrome; 77 non-thrombotic iliac lesions). Primary outcome measures were major adverse events at 30 days 12-month primary (freedom from target vessel revascularization, thrombotic occlusion, or stenosis > 50%). Secondary outcomes included Venous Clinical Severity Score Pain Assessment Chronic Quality-of-Life Questionnaire assessments (hypothesis tested). observations patency, lesion revascularization (TVR/TLR), assessment integrity through 36 months. Results Freedom was 93.5%, statistically higher than a pre-specified performance goal 89% ( p = 0.032) while 12 months 88.6%, also 74% < 0.0001). Mean quality-of-life improved compared to baseline values 84% (Kaplan–Meier analysis) freedom TVR/TLR 88.1%. There no embolization/migration, core laboratory assessed fractures reported Six deaths reported; none adjudicated as device procedure related. Conclusion The successfully deployed obstructive lesions met At 3 years, 84%, reintervention rates low, standardized pain baseline, there migration fractures. Level Evidence 2—prospective, multicenter, controlled clinical without concurrent control randomization. Pre-specified endpoints hypothesis-tested goals derived peer-reviewed literature. Registration clinicaltrials.gov Unique Identifier NCT02655887.