VERNACULAR: 36-Month Findings for the Venovo Venous Stent

Use of the Venovo Venous Stent (BD) to treat iliofemoral vein obstructions is associated with lasting improvements in pain and patient comfort and a 36-month patency rate of 79.5% (84% in the Kaplan-Meier analysis), according to long-term data presented at ISET 2022 by Robert Lookstein, MD, of Mount Sinai Health, New York, NY.

Venovo is a self-expanding nitinol stent designed for vein wall apposition that was approved in March 2019 for the treatment of symptomatic iliofemoral venous outflow obstruction.

VERNACULAR is a pivotal IDE study conducted in 22 sites in the U.S., Europe, and Australia. Participants (n = 170) had symptomatic venous outflow obstruction in the iliac and femoral veins at ³50% on contrast venography. Mean age at baseline was 52 years and 37% were male. The majority of patients (n = 93) had post-thrombotic syndrome and 77 had nonthrombotic iliac vein lesions).

As previously reported, the trial met its primary outcome measures. Freedom from major adverse events through 30 days was 93.5%, statistically beating the pre-specified performance goal of 89% (P=0.032). Primary patency at 12 months was 88.6%, also statistically higher than a performance goal of 74% (P<0.0001).  

Mean pain scores and quality-of-life measures were statistically improved compared to baseline values at 36 months in what Dr. Lookstein called a “significant shift to lower pain scores” and “a significant shift to greater patient comfort.” (See below)

At 36 months, primary patency was 84% in the Kaplan–Meier analysis and 79.5% in the intention-to-treat population. Freedom from target vessel or target lesion revascularization was 88.1%.

There was no stent embolization/migration, and no core laboratory assessed stent fractures reported through 36 months. Six deaths were reported but none were adjudicated as device- or procedure related.

The 36-month findings from VERNACULAR were published in September 2021 in CardioVascular and Interventional Radiology (Dake MD, et al. 2021;44:1918-1929).