Two-Year Data for Vici Venous Stent Published

August 23, 2018—Stephen A. Black, MD, FRCS(Ed), FEBVS, and colleagues have published 2-year findings from a single-center study evaluating the use of the Vici venous stent (Boston Scientific Corporation) in the European Journal of Vascular & Endovascular Surgery. The retrospective study evaluated 81 patients (101 limbs) undergoing stent placement for treatment of iliofemoral venous occlusion verified by venography and postthrombotic syndrome with Villalta score ≥ 5 at least 12 months after deep vein thrombosis.

Key among the data were primary, assisted primary, and secondary patency rates of 59%, 78%, and 87%, respectively. At 2 years, these figures were observed and reported to be 51%, 73%, and 82%. Clinically significant Villalta score improvement was reported in 37 of 53 limbs at 24 months, and poststenting Villalta scores were significantly lower at each of the 6-, 12-, and 24-month clinical follow-up assessments (P < .001). Subset analyses were conducted regarding stent termination points above and below the inguinal ligament, with no statistically significant difference noted in patency or clinical outcomes.

These data led the investigators to conclude that the Vici venous stent is associated with a good secondary patency rate and durable and substantial symptomatic resolution.

"Currently, there is little published long-term data for the new generation of venous stents, in particular for this subgroup of patients with chronic occlusive disease," said Mr. Black in comments to Endovascular Today regarding the study. Mr. Black is Consultant Vascular Surgeon and Honorary Senior Lecturer at Guy’s and St Thomas’ NHS Foundation Trust and King’s College in London.

"The biggest take home is that good results are achievable even in a traditionally challenging group like this," continued Mr. Black. "However, that is achieved only by working hard and paying attention to detail."

Regarding next steps in the research and how these data might inform future studies, Mr. Black says the experience will lead the group to continue to work on overcoming technical failure—in particular addressing the issue of stent thrombosis seen in this cohort. "We need to improve primary patency, improve patient selection criteria, and understand the mechanisms of failure," he said. "In addition, we need to understand the cost-effectiveness of these treatments in the long run."  

On August 8, Boston Scientific announced an agreement to acquire Veniti, Inc., the Fremont, California-based company that developed the Vici stent system. The platform received CE Mark approval in 2013, and Veniti submitted its premarket approval application to the US FDA in June 2018.