Medtronic has announced the 36-month final results from the ABRE clinical study. The purpose of the ABRE clinical study was to evaluate the safety and effectiveness of the company’s Abre venous self-expanding stent system, intended for the treatment of symptomatic iliofemoral venous outflow obstruction.
The study results were presented in a late-breaking clinical trial session at the American Vein and Lymphatic Society (AVLS) 2022 annual meeting (13–16 October, New Orleans, USA). Stephen Black (Guy’s and St Thomas’ Hospital, London, UK), co-principal investigator for the ABRE study, presented the data.
“The 36-month ABRE data have continued to demonstrate the long-term durability of interventions in patients suffering from deep venous disease,” Black said. “The results show a sustained result in both technical aspects, but more importantly, in patient outcomes.”
The ABRE study included a complex set of patients. Within this patient group:
- 47.5% of patients were categorised as having post-thrombotic syndrome (PTS),
- 35.8% of PTS patients presented with a complete venous occlusion confirmed by the core lab
- Mean lesion length of patients was 112.4mm
- 44% of patients had stents that extended below the inguinal ligament.
Of note, the study results showed:
- Overall, effectiveness following treatment with the Abre venous stent was sustained through 36 months as evidenced by a Kaplan-Meier estimated primary patency rate of 81.6% and a Kaplan-Meier estimated freedom from clinically driven target lesion revascularization (CD-TLR) rate of 89.3%.
- No stent fractures or delayed stent migrations were reported through 36 months.
- Sustained and clinically meaningful improvements were observed through 36 months compared to baseline as measured by EQ-5D and VEINES-QoL quality of life.
- Sustained and clinically meaningful improvements through 36 months as measured by Villalta and VCSS venous functional assessments indicates less severity of PTS disease and venous disease overall.
“Medtronic is strongly committed to the deep venous market. As the 36-month results show, the Abre venous stent system safely and effectively treats venous disease,” said Dave Moeller, president of the Peripheral Vascular Health Operating Unit at Medtronic. “This study included many patients with highly challenging cases, showing that Abre is meaningfully able to improve patients’ quality of life—including those with severe disease—for a long period.”