Optimed recently announced the presentation of two prospective, multicentre trials evaluating the performance and effectiveness of their venous stent systems at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany).
The TOPOS trial two-year results for the Sinus-Obliquus stent system for treatment of post-thrombotic syndrome (PTS) were presented by Tim Sebastian (University Hospital Zurich, Zurich, Switzerland). TOPOS is a prospective, multicentre, single-arm study which included patients with PTS and iliofemoral venous outflow obstruction. At 24 months, TOPOS had a primary stent patency rate of 81%, and secondary patency rate of 96%. Participants had a mean stent length of 22cm with 70% of stents extending beyond the inguinal ligament. The lesion length was longer in comparison to other prospective venous stent trials. Patients also sustained a reduction in disease severity and improvement in quality of life at 24 months. TOPOS did not include patients with non-thrombotic iliac vein lesions, in which patency rates are typically higher than in thrombotic disease.
“We are very encouraged by the durable vessel patency, reduction in symptoms and reversal of physical, social and psychological impairment caused by PTS,” Sebastian outlined. “In particular, this was a challenging PTS study population, with the majority of patients requiring multiple stents extending below the inguinal ligament.”
The STEVECO trial is a prospective, randomised, multicentre, 12-month trial comparing venous stenting using the Sinus-Venous stent to conservative treatment. The study measured Quality of Life, venous disease severity and patency. The population included patients with both PTS and non-thrombotic iliac vein lesions. Houman Jalaie (European Venous Center Aachen-Maastricht, Aachen, Germany) presented the STEVECO trial design and preliminary data.
“STEVECO demonstrates meaningful quality of life improvement comparing venous stenting to conservative treatment in a randomised study,” reported Jalaie. “This will be important evidence to share with our physician colleagues as we seek individualised treatment for our patients.”
“We would like to thank the TOPOS and STEVECO investigators for their contribution to advancing deep venous therapy,” noted Jürgen Kiesel, Optimed’s CEO. “We consider our company an innovator in purpose built stent design. We are committed to supporting physician thought leaders and their pursuit of clinical evidence. These presentations today reaffirm that commitment and we look forward to the future.”