Twelve-Month VERNACULAR Data for Venovo Venous Stent Presented at SIR 2019
March 28, 2019—Michael D. Dake, MD, opened the final plenary session of the Society of Interventional Radiology's (SIR) Annual Scientific Sessions presenting the 12-month data from the VERNACULAR study, which recently led to the first United States FDA approval of a dedicated venous stent.
Dr. Dake reported that the prospective multicenter trial demonstrated a primary patency benefit for the Venovo venous stent (BD Interventional) compared with a historical control at 12 months. Significant improvements in pain and quality of life scores compared with baseline were also observed.
VERNACULAR enrolled 170 patients in the common iliac, external iliac, and common femoral veins at 22 centers in the United States, Europe, and Australia. The trial's primary safety endpoint was freedom from major adverse events at 30 days, and its primary efficacy endpoint was 12-month primary patency. Subgroup analyses for patients with postthrombotic syndrome and nonthrombotic iliac vein lesions were conducted.
The trial's 30-day rate of freedom from major adverse events was 93.5%, besting the performance goal of 89%. The overall 12-month primary patency rate of 88.3% compared favorably with the performance goal of 74%, and the rate of target lesion revascularization was 7.4%. Dr. Dake also showed significant shifts to lower pain scores by Venous Clinical Severity Score and improved quality of life as evaluated by Chronic Venous Insufficiency Quality of Life Questionnaire–20 scores.
All stents were successfully deployed, and no stent fractures were observed at 12 months via core lab analysis. The trial's follow-up period will continue through 3 years, with 2- and 3-year data to be gathered and reported.
Dr. Dake, from the University of Arizona, is the study's principal investigator along with Gerard J. O'Sullivan, MD, from University College Hospital in Galway, Ireland. It was also announced at SIR that Dr. Dake is the society's president-elect.
BD Interventional announced FDA approval of the Venovo stent on March 14, 2019.