The Abre venous stent (Medtronic) remains safe and effective for the treatment of iliofemoral venous obstructive disease out to 24 months. This is according to Erin Murphy (Sanger Heart and Vascular, Atrium Health, Charlotte, USA), who presented the latest ABRE trial data at this year’s International Symposium on Endovascular Therapy (ISET 2022; 16–19 January, Hollywood, USA).
“Iliofemoral obstruction can cause significant venous hypertension that can result in symptoms ranging from pain to oedema, venous claudication, skin changes and ulceration,” Murphy began, informing viewers that stenting can reduce these symptoms and improve quality of life in patients with non-thrombotic venous compression, post-thrombotic disease and acute deep vein thrombosis (DVT). However, the presenter stressed that longer-term safety and efficacy studies for newer venous stents—those she defined as being approved by the US Food and Drug Administration (FDA) between 2017 and 2021—are mandated.
The ABRE trial is a prospective, non-randomised, single-arm study of 200 patients with symptomatic iliofemoral venous outflow treated with the Abre venous stent, Murphy detailed, noting that patients were enrolled from 24 global sites, mostly in the USA. The study incorporates all patient subtypes that develop venous obstruction, the presenter added, including those with acute DVT, non-thrombotic disease and also post-thrombotic disease. The mean age of the patients included in ABRE was 51.5±15.9 years, and 66.5% (133/200) of the patients were female, Murphy conveyed. She highlighted that this was a clinically challenging cohort of patients, specifying that stents in 88 patients (44%) extended below the inguinal ligament.
The investigators conducted follow-up at one, six and 12 months, and then annually thereafter. At ISET 2022, Murphy revealed that effectiveness was sustained though 24 months, with a primary patency of 85.7% and freedom from clinically-driven target lesion revascularisation (CD-TLR) of 90.9%. In addition, the presenter communicated that no stent fractures or stent migrations were reported through 24 months, and that all patients demonstrated sustained and clinically meaningful improvements in quality of life measures and venous functional assessment scores.