Three-Year Outcomes of the Abre Venous Self-Expanding Stent System in Patients with Symptomatic Iliofemoral Venous Outflow Obstruction
Stephen Black, Marc Sapoval, David Dexter, Kathleen Gibson, Raghu Kolluri, Mahmood K. Razavi, Dorian J. deFreitas, Hong Wang, Stephanie Brucato, Erin H. Murphy, Marc Sapoval, Olivier Hartung, Houman Jalaie, Michael Lichtenberg, Gerard J. O’Sullivan, Marzia Lugli, Stephen Black, Steve Bandula, Kathleen Gibson, Erin H. Murphy, David Dexter, Raghu Kolluri, Mahmood K. Razavi, Dorian J. deFreitas, Paul J. Gagne, Charles B. Ross, Akram Khan, Windsor Kwan‐Chun Ting, John H. Rundback, Antonios Gasparis, David Williams, Jeffrey Hnath, Todd Berland, Haraldur Bjarnason
Abstract
PURPOSE: 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. METHODS: The ABRE study was a prospective, multicenter, nonrandomized study that enrolled and implanted Abre venous stents in 200 participants (mean age 51.5 years [SD ± 15.9], 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. RESULTS: 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 postthrombotic syndrome group, and 97.1% in the nonthrombotic iliac vein lesion group through 36 months. The overall mean lesion length was 112.4 mm (SD ± 66.1). 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. CONCLUSIONS: Results from the ABRE study demonstrated sustained patency with a good safety profile after implantation of a dedicated venous stent in patients with symptomatic iliofemoral venous outflow obstruction disease.