VERNACULAR: Venous stent confers patency benefit at 1 year

Michael D. Dake

LAS VEGAS — A venous stent was associated with high rates of primary patency and low rates of target lesion revascularization, according to data presented at VIVA 18.

Researchers conducted the VERNACULAR study to evaluate the performance of the venous stent (Venovo, BD) for treating iliac and femoral vein occlusive disease. Some patients had deep vein thrombosis and/or May-Thurner syndrome and all had venous outflow obstruction of at least 50%.

Michael D. Dake, MD, senior vice president of health sciences and professor of medical imaging, surgery and medicine at the University of Arizona, conducted the nonrandomized, prospective, single-arm study in 170 patients (mean age, 52 years; 63% women).

“This is a self-expanding nitinol stent designed for veins,” Dake said during a presentation. It has 3-mm flared ends designed for vein wall apposition and six radiopaque tantalum markers.”

Endpoints of interest included 1-year primary patency, defined as freedom from target vessel revascularization and freedom from thrombotic occlusion and stenosis greater than 50% as measured by duplex ultrasound; 1-year change in Venous Clinical Severity Score (VCSS) and Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score; and 30-day freedom from major adverse events, including TVR, device- and/or procedure-related death, target limb major amputation, clinically relevant pulmonary embolism, vascular injury requiring revascularization, embolization and/or migration of the stent and device- or procedure-related DVT.

Primary patency at 1 year was superior to the prespecified literature-derived performance goal of 74% (88.3%; 90% CI, 82.4-94.2), Dake said.

Patency was more likely to be achieved in patients with nonthrombotic iliac vein lesions than in patients with postthrombotic syndrome (96.9% vs. 81.3%; P = .01), he said.

At 395 days, freedom from loss of primary patency by Kaplan-Meier sensitivity analysis was 88.9% (90% CI, 83.9-92.4), according to the researchers.

At 1 year, VCSS improved by –1.7 (95% CI, –1.8 to –1.5) and CIVIQ-20 score improved by –15.7 (95% CI, –18.4 to –13), Dake said.

The rate of freedom from 30-day major adverse events was 93.5% (90% CI, 89.5-96.3), which beat the prespecified literature-derived performance goal of 89% (P = .03), he said, noting that all 30-day major adverse events occurred in patients with postthrombotic syndrome.

There were no stent fractures at 1 year and the 1-year rate of freedom from TVR and TLR was 92.6%, according to the researchers.

“The Venovo venous stent when used to treat venous obstructions in the iliac and femoral veins demonstrated a primary patency benefit compared to a historical control at 12 months while demonstrating significant improvement in both VCSS pain scores and CIVIQ-20 quality of life score compared with baseline,” Dake said during the presentation. “Follow-up in the VERNACULAR trial is ongoing through 3 years.”

The device is not yet approved for use in the United States. – by Erik Swain

Reference:

Dake MD, et al. Late-Breaking Clinical Trials. Presented at: VIVA 18; Nov. 5-8, 2018; Las Vegas.

Disclosure: The study was funded by BD. Dake reports he received honoraria from Bard Peripheral Vascular and Cook Medical, consulted for Cook Medical, Novate Medical and W.L. Gore and Associates, and received research funding from Essential Medical, Novate Medical, Shockwave Medical and W.L. Gore and Associates.