Medtronic’s ABRE Study 36-Month Clinical Outcomes Characterized by Initial Clinical Presentation

November 2, 2022—Clinical outcomes at 36 months categorized by initial clinical presentation in the ABRE study of the Abre venous self-expanding stent (Medtronic) were presented by Stephen A. Black, MD.

The ABRE study is a prospective, interventional, multicenter study that evaluated 200 patients with symptomatic iliofemoral venous outflow obstruction. Patients were categorized based on initial clinical presentation by the enrolling investigator as postthrombotic syndrome (PTS; 47.5%), nonthrombotic iliac vein lesion (NIVL; 36.0%), or acute (posttreatment) deep vein thrombosis (aDVT; 16.5%).

Primary safety and effectiveness outcome measures were major adverse events at 30 days and primary patency at 12 months, respectively.

Dr. Black revealed the findings in a Late-Breaking Clinical Trials session at The VEINS conference, hosted by the VIVA Foundation and held October 30-31, 2022, in Las Vegas, Nevada.

As summarized in the VIVA Foundation press release, the long-term primary endpoint was freedom from target lesion revascularization (TLR) at 36 months.

Long-term secondary endpoints included primary patency, freedom from clinically driven TLR, delayed stent migration, stent fracture, quality-of-life (QOL) measures, and venous functional assessments through 36 months.

Dr. Black reported that based on Kaplan-Meier estimate, the 3-year primary patency rate was 70.4%, 97.1%, and 76.5% for PTS, NIVL, and aDVT, respectively. There were no stent fractures or delayed stent migrations. Mean EuroQoL five-dimensions index QOL and VEINES-QOL scores improved from baseline for all initial clinical presentations. The mean Villalta score in the target limb and mean Venous Clinical Severity Score decreased from baseline to 36 months for all initial clinical presentations.

The investigators concluded that the 3-year 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 across all initial clinical presentations. Patients in the study who received an Abre venous stent reported clinically significant improvement in QOL and functional outcome measures through 3 years when compared to baseline, advised the VIVA Foundation press release.