VERNACULAR: Two-Year Data Strong for Venovo Venous Stent

Hollywood, FL (January 23, 2020) – At two years, primary patency was 84.3% with the Venovo venous stent (BD) in iliac and femoral vein obstructions, with the rates of freedom from target lesion revascularization (TLR) and target vessel revascularization (TVR) both clocking in at 89.4%.

There were no stent fractures at 2 years, according to Jose Almeida, MD, from the University of Miami Miller School of Medicine, who presented the findings at the International Symposium on Endovascular Therapy (ISET).

Venovo, a self-expanding nitinol stent designed for vein wall apposition, 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.

One-year primary findings showed freedom from major adverse events for 93.5% of patients in the intention-to-treat analysis, surpassing the literature-driven performance goal of 89% (P=.03). Primary patency at 1 year was 88.3%, passing the performance goal of 74% (P <.0001).

Freedom from TLR and TVR at 1 year were both 92.6%.

“There was significant improvement in pain scores and quality of life, compared to baseline, as you would expect with venous disease,” reported Dr. Almeida.

When divided into subgroups according to whether they had post-thrombotic syndrome (PTS; n=93) or non-thrombotic iliac vein lesion (NIVL; n=77), 2-year freedom from TLR and TVR was lower in the PTS group (82.8% for both TLR and TVR) compared to the NIVL group (97.3% for both).

“Patency was better in the non-thrombotic patients as they had less disease and better inflow,” said Dr. Almeida.

Similarly, primary patency for the post-thrombotic patients was 75.4% compared to 95.4% for those with NIVL.

Two-year follow-up was available in 86.4% of patients and patients will be followed for another year, reported Almeida.