Three-Year Outcomes of the Abre Venous Self-Expanding Stent System in Patients with Symptomatic Iliofemoral Venous Outflow Obstruction

• DOI: 10.1016/j.jvir.2024.01.030
• Publication Date: 2024-02-08T04:04:51Z
• Authors: Stephen Black; Marc Sapoval; David J. Dexter; Kathleen Gibson; Raghu Kolluri; Mahmood Razavi; Dorian J. deFreitas; Hong Wang; Stephanie Brucato; Erin Murphy; Marc Sapoval; Olivier Hartung; Houman Jalaie; Michael Lichtenberg; Gerard O’Sullivan; Marzia Lugli; Stephen Black; Steve Bandula; Kathleen Gibson; Erin Murphy; David Dexter; Raghu Kolluri; Mahmood Razavi; Dorian deFreitas; Paul Gagne; Charles Ross; M. Akram Khan; Windsor Ting; John Rundback; Antonios Gasparis; David Williams; Jeffrey Hnath; Todd Berland; Haraldur Bjarnason

To report 36-month outcomes and subgroup analysis of the ABRE Study evaluating the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction disease.The ABRE Study was a prospective, multicenter, non-randomized study that enrolled and implanted Abre venous stents in 200 participants (mean age 51.5±15.9 years and 66.5% women) with symptomatic iliofemoral venous outflow obstruction at 24 global sites. Outcomes assessed through 36 months included patency, major adverse events, stent migration, stent fracture, and quality of life changes. Adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively.Primary, primary-assisted and secondary patency through 36 months by Kaplan-Meier estimates were 81.6%, 84.8% and 86.3%, respectively. The cumulative incidence of major adverse events through 36 months was 10.2%, mainly driven by 12 thrombosis events. Subgroup analyses demonstrated a primary patency of 76.5% in the acute deep vein thrombosis group, 70.4% in the post-thrombotic syndrome group, and 97.1% in the non-thrombotic iliac vein lesion group through 36 months. The mean lesion length was 112.4±66.1 mm. There were no stent fractures or migrations in this study. Quality of life and venous functional assessments demonstrated significant improvements from baseline to 36 months across all patient subsets.Results from the ABRE study demonstrated sustained patency with a good safety profile following implantation of a dedicated venous stent in patients with symptomatic iliofemoral venous outflow obstruction disease.