BD's Venovo Venous Stent Evaluated in 12-Month VERNACULAR Data

November 7, 2018—Michael D. Dake, MD, presented 12-month results from the prospective, multicenter, single-arm VERNACULAR clinical trial at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada.

VERNACULAR was designed to assess the performance of the self-expanding Venovo venous stent (BD Interventional) for the treatment of iliac and femoral vein occlusive disease. The study enrolled 170 patients who were treated at 22 centers in the United States, Europe, and Australia.

The study's primary efficacy measure was 12-month primary patency, defined as freedom from target vessel revascularization and freedom from thrombotic occlusion and stenosis > 50% (derived from duplex ultrasound). Secondary outcomes included the Venous Clinical Severity Score (VCSS) pain assessment and Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20), both hypothesis-tested for improvement at 12 months compared to baseline values.

The 12-month follow-up was completed by 156 patients, including 84 patients with postthrombotic syndrome (PTS) and 72 patients with nonthrombotic iliac vein lesions. All 219 stents were successfully deployed to the intended location.

At VIVA 2018, Dr. Dake reported that the 12-month primary patency rate was 88.3%, which was significantly better than a performance goal (74%) derived from the venous stent literature (P < .0001). The VCSS pain score at 12 months significantly improved from baseline, with a mean improvement in the pain score of -1.7 (P < .0001). CIVIQ-20 scores also significantly improved at 12 months from baseline, with a mean improvement of -15.7 (P < .0001).

Additional observations included a 12-month freedom from target lesion revascularization rate of 92.6% (95% confidence interval, 87.5%–96.1%). Radiographs were assessed by the Yale core lab for stent fractures, with no fractures reported at 12-month follow-up.

Dr. Dake concluded that 1-year results from the VERNACULAR trial demonstrated that the Venovo venous stent could be successfully deployed in obstructive iliac and femoral vein lesions, including acute or chronic deep vein thrombosis, PTS, or venous compression syndrome (eg, May-Thurner), with a primary patency rate of 88.3%, a low reintervention rate of 7.4%, and no core lab–assessed stent fractures.