Stephen Black (London, UK) talks to Venous News about the key 36-month results from the ABRE study, which evaluated the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.
Speaking at the 2022 Venous Endovascular Interventional Strategies (VEINS) meeting (30–31 October; Las Vegas, USA), Black states that the study has “really allowed us to demonstrate the sustainability of intervention in this difficult patient group. We have seen sustained patency and sustained improvements in quality of life and clinical severity scores,” he adds.
“What was different for the ABRE study [compared to other venous stent studies] was we focused on having clear definitions of the three separate populations that we typically treat—non-thrombotic iliac vein lesions, acute deep vein thrombosis and post-thrombotic syndrome,” says Black. “We had 47.5% of patients in the post-thrombotic subgroup, which is typically the hardest group to treat”, he notes, adding that this means “we can have confidence in the long-term patency figures which are sustained out to 36 months at 81.6%”.
Looking to the future Black states that there should be “a big focus on continuing to collect data” and that “we need to address the areas of failure”, for example why some patients do not maintain patency. He concludes by stating that he “would like to see a growth in the number of patients with deep venous disease being referred for consideration of intervention”.
Risks include: Pain, myocardial infarction, pulmonary embolism, and restenosis of stented segment.
This video is sponsored by Medtronic.
Intended Use/Indications: The Abre™ venous self-expanding stent system (Abre™ stent system) is indicated for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Contraindications: Do not use the Abre™ stent system with patients with known hypersensitivity to nickel titanium (nitinol), with patients who are judged to have a lesion that prevents complete inflation of a balloon dilatation catheter or proper placement of the stent or the stent delivery system, and with patients in whom anticoagulant or antiplatelet therapy is contraindicated.
Potential Adverse Effects of the Device on Health: The potential adverse effects (e.g., complications) associated with the use of the Abre™ stent system include, but are not limited to, access failure, access site infection, allergic reaction to contrast medium or procedure medications; aneurysm; AV fistula; bleeding; bruising; death; device breakage; device maldeployment; edema; embolization; fever; hematoma; hypertension; hypotension, nausea, or other vasovagal response; infection; myocardial infarction, arrhythmia, or other cardiovascular insufficiency; open surgical repair; pain; pseudoaneurysm; renal insufficiency or renal failure (new or worsening); respiratory distress or pulmonary embolism; sepsis; stent fracture; stent malapposition; stent malposition; stent migration; stroke, paradoxical embolism, transient ischemic attack, or intracerebral hemorrhage; tissue necrosis; venous occlusion, restenosis, or thrombosis, within or outside of stented segment; and vessel damage, including intimal injury, dissection, perforation, or rupture.
Warnings, precautions, and instructions for use can be found in the product labeling at manuals.medtronic.com.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.