Abstract No. 52 ▪ FEATURED ABSTRACT Three-year results from the prospective, multicenter VERNACULAR trial: treatment of iliofemoral venous disease with the self-expanding Venovo venous stent

Abstract

To assess performance and safety of the Venovo venous stent, a self-expanding stent specifically designed for the treatment of iliofemoral vein occlusions. Investigators in the international, multicenter VERNACULAR study enrolled 170 patients—93 post-thrombotic syndrome (PTS) and 77 non-thrombotic iliac vein lesion (NIVL) —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 and freedom from thrombotic occlusion and duplex-ultrasound derived stenosis >50%. Secondary outcomes included the Venous Clinical Severity Score (VCSS) Pain Assessment, Quality of Life (CIVIQ-20), target lesion revascularization (TLR), and stent fracture assessment (Yale venographic core laboratory) through 36 months. Freedom from MAEs through 30 days was 93.5%, non-inferior to a pre-specified performance goal (PG) of 89% (P = 0.032) while primary patency at 12 months was 88.3%, superior to a PG of 74% derived from the venous stent literature (P < 0.0001). Follow up at two years was 86.4% (147/170 patients). Primary patency at 24 months was 83.2% (90% CI 77.3%, 89.1%); 77.3% for the PTS subgroup and 95.2% for the NIVL patients. Primary patency estimated by Kaplan-Meier survival analysis was 84.3% for the ITT group at 760 days. The 24-month TLR rate was 10.9% resulting in a freedom from TLR of 89.4% (95% CI 83.6%, 93.7%). The mean VCSS Pain Score improved from 0.6 at 12 months to 0.4 (95% CI: 0.46, 0.74) at 24-months with an overall improvement from baseline of 1.9 (median 2.0); CIVIQ-20 scores at two years also improved (15.6 points) from baseline values. No stent fractures were observed at 12 or 24 months. 36-month follow-up is ongoing. The Venovo venous stent was deployed successfully in obstructive iliofemoral vein lesions (acute technical success: 100%). Primary patency was 88.3% at 12 months and 83.2% at 24 months. Reintervention rates were low, with no stent fractures reported through two years. Final, three-year results of the VERNACULAR Study will be presented at SIR 2021.