Abstract
BACKGROUND: Post-thrombotic syndrome is common after deep-vein thrombosis and can cause severe symptoms involving the limbs that impair patients' activity and quality of life. Endovascular therapy can eliminate chronic venous obstruction and is hypothesized to reduce the severity of post-thrombotic syndrome. METHODS: We randomly assigned 225 patients with moderate or severe post-thrombotic syndrome and imaging-confirmed iliac-vein obstruction to receive endovascular therapy (iliac-vein stent placement and enhanced antithrombotic therapy) plus standard post-thrombotic syndrome care or standard post-thrombotic syndrome care alone. The severity of post-thrombotic syndrome at 6 months (the primary outcome) was assessed with the validated Venous Clinical Severity Score (VCSS) tool (scores range from 0 to 30, with higher scores indicating more severe post-thrombotic syndrome) by evaluators who were unaware of the group assignments. Key secondary outcomes included venous disease-specific and overall quality of life. RESULTS: At 6 months, the severity of post-thrombotic syndrome was lower in the endovascular-therapy group than in the no-endovascular-therapy group (mean [±SD] VCSS, 8.1±5.1 vs. 10.0±4.9; adjusted difference, -2.0; P = 0.001). Venous disease-specific quality of life as assessed with the Venous Insufficiency Epidemiological and Economic Study Quality of Life questionnaire was better in the endovascular-therapy group than in the no-endovascular-therapy group at 6 months (adjusted difference, 14.5 points; P<0.001), as was overall quality of life as assessed with the Medical Outcomes Study 36-Item Short-Form Health Status Survey physical component summary score (adjusted difference, 6.1 points; P<0.001); scores on both tools range from 0 to 100. Through 6 months, bleeding was more common in the endovascular-therapy group than in the no-endovascular-therapy group (in 11.6% vs. 3.6% of the patients; P = 0.03). CONCLUSIONS: Among patients with moderate or severe post-thrombotic syndrome and iliac-vein obstruction, endovascular therapy led to less severe post-thrombotic syndrome and better health-related quality of life than standard care over a 6-month period but with a higher risk of bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; C-TRACT ClinicalTrials.gov number, NCT03250247.).