The TOPOS study

VASA, vol. 53, pp. 217–224

Abstract

Summary: Background: We aimed to study the long-term safety and efficacy of oblique venous stents for post-thrombotic syndrome (PTS) with iliac vein compression. Patients and methods: In the multinational, prospective, single-arm TOPOS study, PTS patients scheduled for endovascular therapy with the sinus-Obliquus® stent and optional distal extension with the sinus-Venous® or sinus-XL Flex® stent were enrolled at eight European vascular centres between October 2016 and December 2020. The primary outcome was primary stent patency at 24 months, and secondary outcomes included the clinical course of PTS (Villalta score, revised Venous Clinical Severity Score [rVCSS], Visual Analog Scale [VAS] of pain), quality of life changes (Chronic Venous Insufficiency Quality of Life Questionnaire, CIVIQ-20), and device-related complications. Results: We enrolled 60 patients (mean age 46±15 years, 68% women, 13% active ulcers): 80% required stent extension (70% below the inguinal ligament). The primary patency rate at 24 months was 80.7% (95%CI 68.1–90.0%); it was higher in patients without vs. those with stent extension (90.9% vs. 78.3%, p=.01). Compared to baseline, the Villalta, rVCSS, pain VAS, and CIVIQ-20 decreased by a median of 8 (interquartile range (IQR): 4–11), 5 (IQR: 3–7), 3 (IQR: 2–5), and 17 (IQR: 6–22) points, respectively; p<.001 for all parameters. Overall, 9 events of acute stent occlusion, 4 symptomatic stent stenosis, and 1 pulmonary embolism occurred. We did not observe major bleeding events or contralateral thrombosis. Conclusions: Endovascular treatment with the oblique stent and optional stent extension was safe and resulted in high patency rates at 24 months. The reduction in PTS severity was substantial and persisted over 2-year follow-up.

Authors 11

1. Tim Sebastian

   University Hospital Zurich

   Affiliation as printed

   Department of Angiology, University Hospital Zurich, Switzerland

2. Stefano Barco

   University Medical Center of the Johannes Gutenberg University Mainz · University Hospital Zurich

   Affiliation as printed

   Center for Thrombosis and Hemostasis, University Medical Center Mainz, Germany

   Department of Angiology, University Hospital Zurich, Switzerland

3. Davide Voci

   University Hospital Zurich

   Affiliation as printed

   Department of Angiology, University Hospital Zurich, Switzerland

4. Michael K. W. Lichtenberg

   Klinikum Arnsberg

   Affiliation as printed

   Department of Angiology, Arnsberg Medical Center, Arnsberg, Germany

5. Oliver Schlager

   Medical University of Vienna

   Affiliation as printed

   Department of Medicine II, Division of Angiology, Medical University of Vienna, Austria

6. Houman Jalaie Aachen

   Universitätsklinikum Aachen · RWTH Aachen University

   Affiliation as printed

   European Vascular Center Aachen-Maastricht, University Hospital RWTH Aachen, Germany

7. Rick de GRAAF
   Affiliation as printed

   Department of Radiology, Interventional Radiology and Nuclear Medicine, Clinic of Friedrichshafen, Germany

8. Christian Erbel

   Heidelberg University · University Hospital Heidelberg

   Affiliation as printed

   Department of Cardiology, Angiology, and Pneumology, Heidelberg University Hospital, Heidelberg, Germany

9. Alexander Maßmann

   Robert Bosch Hospital

   Affiliation as printed

   Department of Radiology and Nuclear Medicine, Robert-Bosch-Krankenhaus, Stuttgart, Germany

10. Marc Schindewolf

    University Hospital of Bern

    Affiliation as printed

    Division of Angiology, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland

11. David Spirk

    University of Bern

    Affiliation as printed

    Institute of Pharmacology, University of Bern, Switzerland