10:30 AM Abstract No. 1 ■ ABSTRACT OF THE YEAR A prospective, multicenter evaluation of the Venovo self-expanding vascular stent used to treat obstructive lesions of the iliac and femoral veins: 12-month results from the VERNACULAR trial

Abstract

To assess the performance of the Venovo Venous Stent (Becton Dickinson Peripheral Interventions) for the treatment of iliac and femoral vein occlusions. The VERNACULAR study was conducted at 22 centers in the United States, Europe, and Australia. Primary endpoints were major adverse events (MAEs) through 30 days and 12-month primary patency, defined as freedom from target vessel revascularization, thrombotic occlusion, and duplex-ultrasound derived stenosis >50%. Secondary outcomes included the Venous Clinical Severity Score (VCSS) Pain Assessment and Quality of Life (CIVIQ-20), both tested for superiority to baseline values. Radiographs were assessed at 12 months for stent fracture by the Yale Angiographic Core Lab. The 12-month interim report reviewed 156 patients (91.8%), including 84 post-thrombotic syndrome (PTS) and 72 non-thrombotic iliac vein lesion (NIVL) patients. All stents (223) were successfully deployed to the intended location. Freedom from MAEs through 30 days was 93.5%, non-inferior to a performance goal (PG) of 89% (p = 0.032). Primary patency at 12 months was 88.3% (81.3% PTS; 96.9% NIVL), superior to a performance goal (74% PG) derived from the venous stent literature (p < 0.0001). An additional sensitivity analysis of primary patency estimated a survival probability of 88.9% (Kaplan-Meier) for the intention to treat (ITT) population. The VCSS pain score at 12 months was 0.6 (95% CI: 0.46, 0.74), a significant improvement from baseline (2.3; p < 0.0002); CIVIQ-20 scores also improved significantly (15.7 points) from baseline values (p < 0.0001). Additional observations included 12-month freedom from target lesion revascularization of 92.6% (90% CI: 87.5%, 96.1%) for the ITT group (PTS: 87.6%; NIVL: 98.6%). No stent fractures were observed at 12-months. Initial results from the VERNACULAR trial demonstrated that the Venovo stent could be deployed successfully in obstructive iliofemoral vein lesions. Primary patency was 88.3% at 12 months. Rates of MAEs and reintervention were low, with no stent fractures reported through one year. Follow up is ongoing through 3 years.