The TOPOS study.

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Venous Thromboembolism

Background:

• Post-thrombotic syndrome (PTS) with iliac vein compression significantly impacts patient quality of life.
• Endovascular treatment is a key therapeutic option for managing PTS.
• Long-term safety and efficacy data for specific venous stents in PTS are crucial.

Purpose of the Study:

• To evaluate the long-term safety and efficacy of oblique venous stents for PTS.
• To assess primary stent patency and clinical outcomes at 24 months.
• To analyze the impact on PTS severity scores and quality of life.

Main Methods:

• Prospective, single-arm, multinational TOPOS study.
• 60 PTS patients received sinus-Obliquus® stent, with optional distal extensions.
• Primary endpoint: 24-month primary stent patency; secondary: Villalta score, rVCSS, VAS, CIVIQ-20, complications.

Main Results:

• 24-month primary patency rate was 80.7%.
• Significant reductions in Villalta score, rVCSS, pain VAS, and CIVIQ-20 (p<.001).
• Low rates of acute stent occlusion (9) and symptomatic stenosis (4); no major bleeding or contralateral thrombosis.

Conclusions:

• Endovascular treatment with oblique stents and extensions is safe for PTS.
• High patency rates and substantial, persistent reduction in PTS severity observed at 24 months.
• Supports the use of oblique venous stents for managing iliac vein compression in PTS.