June 16, 2020
Medtronic's ABRE Venous Stent Study Meets Safety and Effectiveness Endpoints; 12-Month Data Presented
June 16, 2020—Twelve-month data from Medtronic's ABRE pivotal, investigational device exemption, venous stent study were presented by Stephen Black, MD, during a Charing Cross (CX) 2020 virtual session dedicated to deep venous disease. The prospective multicenter international study assessing the Abre venous stent system in patients with symptomatic venous outflow obstruction met its primary safety and effectiveness endpoints, with a 2% (4/200) rate of major adverse events at 30 days and an overall 12-month primary patency rate of 88% (162/184). The prespecified primary safety and effectiveness performance goals were 12.5% and 75%, respectively.
The ABRE study enrolled 200 patients at 24 centers in the United States and Europe to evaluate the Abre self-expanding venous stent for treatment. Follow-up data were available for 95.5% (191/200) of patients. The population included patients with acute deep vein thrombosis (17%), postthrombotic syndrome (PTS; 47%), and nonthrombotic iliac vein lesion (36%) presentations. Mr. Black highlighted that the study population included 88 (44%) patients who required a stent extending below the inguinal ligament—a challenging clinical scenario probed at length throughout the CX 2020 session, and 52% had a history of venous thromboembolism.
Device success was reported in 100% of cases, and no stent fractures or delayed migrations have yet been observed. Major adverse event endpoint findings included zero patient deaths or major bleeding complications through 30 days; one clinically significant pulmonary embolism was reported (0.5%), as were three (1.5%) instances of stent thrombosis. The effectiveness outcome for primary patency at 12 months was defined as freedom from occlusion and ≥ 50% restenosis of the stented segment of the target lesion and freedom from clinically driven target lesion revascularization. Outcomes and events were adjudicated via a clinical events committee or imaging core lab.
Sustained and statistically significant improvements in quality-of-life data and venous functional assessment scores versus baseline were described (VEINES-QOL/Sym, EQ-5D, Villalta, and Venous Clinical Severity Score).
Mr. Black, consultant vascular surgeon at London's Guy's and St. Thomas' Hospital presented the data on behalf of Co-Principal Investigator Erin H. Murphy, MD, FACS, vascular surgeon and Director, Venous and Lymphatic Institute, Sanger Heart & Vascular at Atrium Health in Charlotte, North Carolina. Follow-up will continue through 3 years.
“The ABRE results add to the growing data pool that demonstrates treating venous patients is both safe and efficacious,” concluded Mr. Black in comments to Endovascular Today. “In particular, the ABRE study includes a significantly higher proportion of difficult PTS patients with stent extension below the ligament, and no fractures were observed.”
The Abre venous stent system has CE Mark and is available in Europe; in the United States, it is an investigational device not yet approved for commercial use.