3:18 PM Abstract No. 84 Iliac and femoral vein occlusive disease treated with a self-expanding venous stent: 24-month results from the prospective, multicenter VERNACULAR trial

Abstract

To assess the performance of a self-expanding stent specifically designed for veins (VENOVO Venous Stent) for the treatment of iliac and femoral vein occlusions. The VERNACULAR study was conducted at 22 centers in the United States, Europe, and Australia. The intent-to-treat population included 170 patents, 93 postthrombotic syndrome patients (PTS) and 77 non-thrombotic iliac vein lesion patients (NIVL). 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 primary patency, the Venous Clinical Severity Score (VCSS) Pain Assessment, Quality of Life (CIVIQ-20), and target lesion revascularization (TLR) at 24 months. Radiographs were assessed for stent fracture by the venographic core laboratory. Freedom from MAEs through 30 days was 93.5%, non-inferior to a 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. Observations from the VERNACULAR trial at two years supported the 12-month results. The VENOVO stent could be deployed successfully in obstructive iliofemoral vein lesions. 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.