Medtronic’s Abre Venous Self-Expanding Stent System Shows Sustained Effectiveness at 36 Months

October 14, 2022—Medtronic announced that the 36-month, final results from the ABRE clinical study were presented by Professor Stephen Black, MD, in a late-breaking clinical trial session at AVLS 2022, the 36th annual congress of the American Vein and Lymphatic Society held October 13-16 in New Orleans, Louisiana.

Prof. Black, who is Consultant Vascular Surgeon at Guy’s and St. Thomas’ Hospital in London, United Kingdom, serves as coprincipal investigator for the ABRE study.

Medtronic stated that the purpose of the ABRE clinical study was to evaluate the safety and effectiveness of the Abre venous self-expanding stent system, which is intended for the treatment of symptomatic iliofemoral venous outflow obstruction. The prospective, interventional, single-arm, multicenter, worldwide study enrolled patients across the spectrum of deep venous disease, including patients with postthrombotic syndrome (PTS) and nonthrombotic iliac vein lesion, and those who presented with an acute deep vein thrombosis.

“The 36-month ABRE data has continued to demonstrate the long-term durability of interventions in patients suffering from deep venous disease,” commented Prof. Black in the company’s press release. “The results show a sustained result in both technical aspects, but more importantly, in patient outcomes.”

According to Medtronic, the ABRE study was composed of a complex set of patients, including the following characteristics:

• PTS in 47.5% of patients
• Complete venous occlusion confirmed by the core lab in 35.8% of PTS patients
• Mean lesion length of 112.4 mm
• Stents extended below the inguinal ligament in 44% of patients

The company summarized the key findings through 36 months as follows:

• Effectiveness after treatment with the Abre venous stent was sustained with a primary patency rate of 81.6% and a freedom from clinically driven target lesion revascularization rate of 89.3% (both by Kaplan-Meier estimate)
• No stent fractures or delayed stent migrations
• Sustained and clinically meaningful improvements compared to baseline per EQ-5D and VEINES-QoL quality-of-life measurement
• Sustained and clinically meaningful improvements as measured by Villalta and Venous Clinical Severity Score venous functional assessments indicate less severity of PTS disease and venous disease overall