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

J Vasc Interv Radiol. 2024 May;35(5):664-675.e5. doi: 10.1016/j.jvir.2024.01.030. Epub 2024 Feb 8.

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.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Aged
  • Endovascular Procedures* / adverse effects
  • Endovascular Procedures* / instrumentation
  • Female
  • Femoral Vein* / diagnostic imaging
  • Femoral Vein* / physiopathology
  • Humans
  • Iliac Vein* / diagnostic imaging
  • Iliac Vein* / physiopathology
  • Male
  • May-Thurner Syndrome / diagnostic imaging
  • May-Thurner Syndrome / physiopathology
  • May-Thurner Syndrome / therapy
  • Middle Aged
  • Postthrombotic Syndrome / diagnostic imaging
  • Postthrombotic Syndrome / etiology
  • Postthrombotic Syndrome / physiopathology
  • Postthrombotic Syndrome / therapy
  • Prospective Studies
  • Prosthesis Design*
  • Quality of Life*
  • Risk Factors
  • Stents*
  • Time Factors
  • Treatment Outcome
  • Vascular Patency*
  • Venous Thrombosis / diagnostic imaging
  • Venous Thrombosis / physiopathology
  • Venous Thrombosis / therapy