ABRE Study: Clinical Outcomes Through 36 Months

Friday, October 14, 2022

9:09 AM – 9:22 AM US CDT

Location: Celestin D/E (Live Stream)

Presenting Author(s)

Stephen Black, MD, FRCS(Ed), FEBVS

Consultant Vascular Surgeon
Professor of Venous Surgery
Surgeon
Surrey, England, United Kingdom

Disclosure: Medtronic (Self, Products/Services: Yes.): Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness

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Co-Author(s)

Erin Murphy, MD, FACS

Vascular Surgeon, Director of the Venous and Lymphatic Institute
Sanger Heart and Vascular, Atrium Health
Charlotte, North Carolina

Disclosure: Boston Scientific (Self) : Consultant/Advisory Board (Products and Services: Supplies); Cook (Self) : Consultant/Advisory Board (Products and Services: Supplies); Cordis (Self) : Consultant/Advisory Board (Products and Services: Supplies); Gore (Self) : Consultant/Advisory Board (Products and Services: Supplies); Inari (Self) : Consultant/Advisory Board (Products and Services: Supplies); Medtronic (Self) : Consultant/Advisory Board (Products and Services: Supplies); Philips (Self) : Consultant/Advisory Board (Products and Services: Supplies)

Introduction, Objectives, and/or Purpose: To report the three-year safety and effectiveness outcomes following treatment of iliofemoral venous outflow obstruction with the Abre venous self-expanding stent.

Methods: The ABRE Study is a prospective, interventional, multicenter study that evaluated 200 participants with symptomatic iliofemoral venous outflow obstruction. Participants were treated with at least one Abre venous self-expanding stent between December 2017 and November 2018 and were followed for 36 months through study closure in 2022. Participants were from 24 centers in the United States, France, Germany, Ireland, Italy, and the United Kingdom. Primary outcome measures from the pivotal phase of the study for safety and effectiveness were major adverse events at 30 days and primary patency at 12 months. The long-term primary endpoint was freedom from target lesion revascularization (TLR) at 36 months. Long-term secondary endpoints included primary patency, delayed stent migration, stent fracture, quality of life measures (QoL), and venous functional assessments through 36 months.

Results: Patients were classified by the enrolling Investigator as post-thrombotic syndrome (47.5%), non-thrombotic iliac vein lesion (36.0%), and acute (post treatment) deep vein thrombosis (16.5%). Eighty-eight participants (44%) required stent extension below the inguinal ligament. The major adverse event rate at 30 days as well as the 12-month primary patency rate were previously published in Circulation: Cardiovascular Interventions. Based on Kaplan-Meier estimate the 3-year freedom from TLR rate was 83.7% and the primary patency rate was 81.6%. No stent fractures or delayed stent migrations were reported. Mean EQ-5D Index QoL score increased from 0.66±0.24 at baseline to 0.79±0.21. The mean VEINES-QoL score increased from 49.9±25.4 at baseline to 71.3±27.0 while the mean VEINES-Sym score increased from 51.8±25.0 at baseline to 72.4±26.1. The mean Villalta score in the target limb decreased from 11.2±5.7 at baseline to 4.9±5.1 and the mean Venous Clinical Severity Score decreased from 8.8±4.7 at baseline to 4.4±4.0.

Conclusion(s): The long-term outcomes of the ABRE Study support the safety and effectiveness of the Abre venous self-expanding stent when used to treat symptomatic iliofemoral venous outflow obstruction. Participants that received an Abre venous stent reported clinically significant improvement in quality-of-life and functional outcome measures through 3 years when compared to baseline.