Endovascular Therapy for Post-Thrombotic Syndrome — A Randomized Trial

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.).

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Publication Details

Journal
New England Journal of Medicine
Published
2026-04-13
DOI
https://doi.org/10.1056/nejmoa2519001
Citations
2
Primary Topic
Venous Thromboembolism Diagnosis and Management
Type
article
Field-Weighted Citation Impact
29.49

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article

Endovascular Therapy for Post-Thrombotic Syndrome — A Randomized Trial

Akhilesh K. Sista, Daniel A. Leung, Kathryn Z. Mikkelsen, Siddhant Thukral et al.
2 citations
New England Journal of Medicine
Venous Thromboembolism Diagnosis and Management
29.49
article

Endovascular Therapy for Post-Thrombotic Syndrome — A Randomized Trial

Akhilesh K. Sista, Daniel A. Leung, Kathryn Z. Mikkelsen, Siddhant Thukral, Mahmood K. Razavi, Bhavraj Khalsa, S. Parpia, Natalie Weger, William A. Marston, Nassir Rostambeigi, Anthony J. Comerota, Borong Wang, Minhaj S. Khaja, Kush Desai, Aditya Sharma, Alfonso Tafur, Mary Clare Derfler, P. Kavali, Riyaz Bashir, S. Kahn, Patricia Nieters, Suresh Vedantham, Elizabeth A. Magnuson, Leslie Lake, Elaine M. Majerus, I. Weinberg, Angela Oliver, K. Sanfilippo, Ronald Winokur, Ezana M. Azene, Cassius Iyad Ochoa Chaar, Cassandra Hardy, Suman M. Wasan, Ajinkya Desai, K. Pallav Kolli, Naganathan Mani, Samuel Z. Goldhaber, Sanjeeva P. Kalva, David J. Cohen
article en
2 citations

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.).

New England Journal of Medicine
University of North Carolina at Chapel Hill (US), Brigham and Women's Hospital (US), Harvard University (US), University of California, San Francisco (US), Washington University in St. Louis (US), Cornell University (US), University of Michigan (US), Jacksonville College (US), Jewish General Hospital (CA), WinnMed (US), Jackson Memorial Hospital (US), University of Mississippi Medical Center (US), Yale University (US), Massachusetts General Hospital (US), Presbyterian Hospital (US), Northwestern University (PH), Mallinckrodt (United States) (US), Atrium Medical Cente (US), Christiana Hospital (US), Boston VA Research Institute (US), Evanston Hospital (US), Duke Medical Center (US), St. Joseph Hospital (US), Saint Luke's Hospital (US), University of Iowa Health Care (US), Cardiovascular Research Foundation (US), Mayo Clinic in Florida (US), Inova Alexandria Hospital (US), National Blood Clot Alliance (US), Orange County Heart Institute and Research Center (US), Wake Forest University (US), McGill University (CA), University of Missouri–Kansas City (US), The University of Texas Southwestern Medical Center (US), McMaster University (CA)
Washington University in St. Louis, Society of Interventional Radiology Foundation, American Vein and Lymphatic Society, National Institutes of Health, Canadian Institutes of Health Research, National Heart, Lung, and Blood Institute, National Center for Advancing Translational Sciences
Openalex Percentile: Top 0%
Venous Thromboembolism Diagnosis and Management
29.49
DOIOpen Access PDFOpenAlex
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