Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER ® , RE-COVER™ II, and RE-MEDY™
Abstract
It is unclear whether thrombophilia causes resistance to anticoagulant therapy. Post hoc analyses of data from RE-COVER ® , RE-COVER ™ II, and RE-MEDY ™ were performed to compare dabigatran etexilate with warfarin for the treatment and prevention of venous thromboembolism (VTE) in patients with thrombophilia or antiphospholipid antibody syndrome (APS). There were no significant differences in symptomatic VTE/VTE-related deaths between dabigatran etexilate and warfarin in patients with or without thrombophilia. All bleeding event categories were less frequent with dabigatran etexilate than with warfarin, regardless of whether patients had thrombophilia, no thrombophilia, or were not tested. However, these differences did not reach significance in every group. In patients with APS, there was no significant difference in VTE/VTE-related deaths between the two treatment arms. Rates of bleeding events tended to be lower with dabigatran etexilate than with warfarin, reaching statistical significance for any bleeding event. In conclusion, the efficacy and safety of dabigatran etexilate were not significantly affected by the presence of thrombophilia or APS. ClinicalTrials.gov RECOVER IDENTIFIER NCT00291330; RECOVER II IDENTIFIER NCT00680186; RE-MEDY IDENTIFIER NCT00329238.
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In a post-hoc analysis of antiphospholipid syndrome patients in three RCTs of dabigatran versus warfarin and one RCT of rivaroxaban versus warfarin in venous thrombotic antiphospholipid syndrome, there were no differences in outcomes between direct oral anticoagulants and vitamin K antagonists for venous thrombosis.
“In a post-hoc analysis of patients with APS included in three RCTs of dabigatran versus warfarin,26 and in one RCT of rivaroxaban versus warfarin in patients with venous thrombotic APS,27 there were no differences in outcomes between treatment with DOACs and VKA for venous thrombosis”
From EULAR recommendations for the management of antiphospholipid syndrome in adults (2019) · cites this paper as [26]
Cites
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Oral Rivaroxaban for Symptomatic Venous Thromboembolism
(2010) · New England Journal of Medicine · doi:10.1056/nejmoa1007903 · Cited by 3,237 · see citing works
Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism
The Hokusai-VTE Investigators (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1306638 · Cited by 1,869 · see citing works
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EULAR recommendations for the management of antiphospholipid syndrome in adults
Tektonidou, M. G., Andreoli, L., Limper, M., Amoura, Z., Cervera, R., Costedoat-Chalumeau, N., Cuadrado, M. J., Dörner, T., Ferrer-Oliveras, R., Hambly, K., et al. (2019) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2019-215213 · Cited by 1,261 · see citing works
Antithrombotic Therapy for VTE Disease
Stevens, S. M., Woller, S. C., Kreuziger, L. B., Bounameaux, H., Doerschug, K., Geersing, G.-J., Huisman, M. V., Kearon, C., King, C. S., Knighton, A. J., et al. (2021) · Chest · doi:10.1016/j.chest.2021.07.055 · Cited by 1,043 · see citing works
How I treat recurrent venous thromboembolism in patients receiving anticoagulant therapy
Schulman, S. (2017) · Blood · doi:10.1182/blood-2017-03-742304 · Cited by 62 · see citing works
Self-citation
- Authors
- Goldhaber, S. Z., Eriksson, H., Kakkar, A., Schellong, S., Feuring, M., Fraessdorf, M., Kreuzer, J., Schueler, E., & Schulman, S.
- Affiliations
- Brigham and Women's Hospital (US)
- Sahlgrenska University Hospital (SE)
- Thrombosis Research Institute (GB)
- Krankenhaus Dresden-Friedrichstadt (DE)
- Boehringer Ingelheim (Germany) (DE)
- Accovion GmbH, Eschborn, Germany
- Thrombosis and Atherosclerosis Research Institute (CA)
- Corresponding author
- Goldhaber, Samuel Z
- ORCID
- Venue
- Vascular Medicine
- Publisher
- SAGE Publications
- Published
- 2016-11-02
- Volume
- 21
- Issue
- 6
- Pages
- 506-514
- ISSN
- 1358-863X (ISSN-L)
- 1477-0377
- OpenAlex
- W2548912661
- Cited by
- 89
- References
- 3
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 12 · 2023: 10 · 2022: 14 · 2021: 9 · 2020: 16 · 2019: 13 · 2018: 6 · 2017: 1
- FWCI
- 6.60
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Vascular Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bayer Fund
- National Institutes of Health
- Topics
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Keywords
- dabigatran etexilate, warfarin, acute venous thromboembolism, thrombophilia, antiphospholipid syndrome, direct oral anticoagulants, bleeding events
- MeSH terms
- Dabigatran, Acute Disease, Adult, Aged, Anticoagulants, Antithrombins, Female, Fibrinolytic Agents, Hemorrhage, Humans, Male, Middle Aged, Risk Factors, Time Factors, Warfarin, Randomized Controlled Trials as Topic, Treatment Outcome, Thrombophilia, Kaplan-Meier Estimate, Venous Thromboembolism
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