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Dabigatran versus Warfarin in Patients with Mechanical Heart Valves
Abstract
BACKGROUND: Dabigatran is an oral direct thrombin inhibitor that has been shown to be an effective alternative to warfarin in patients with atrial fibrillation. We evaluated the use of dabigatran in patients with mechanical heart valves. METHODS: In this phase 2 dose-validation study, we studied two populations of patients: those who had undergone aortic- or mitral-valve replacement within the past 7 days and those who had undergone such replacement at least 3 months earlier. Patients were randomly assigned in a 2:1 ratio to receive either dabigatran or warfarin. The selection of the initial dabigatran dose (150, 220, or 300 mg twice daily) was based on kidney function. Doses were adjusted to obtain a trough plasma level of at least 50 ng per milliliter. The warfarin dose was adjusted to obtain an international normalized ratio of 2 to 3 or 2.5 to 3.5 on the basis of thromboembolic risk. The primary end point was the trough plasma level of dabigatran. RESULTS: The trial was terminated prematurely after the enrollment of 252 patients because of an excess of thromboembolic and bleeding events among patients in the dabigatran group. In the as-treated analysis, dose adjustment or discontinuation of dabigatran was required in 52 of 162 patients (32%). Ischemic or unspecified stroke occurred in 9 patients (5%) in the dabigatran group and in no patients in the warfarin group; major bleeding occurred in 7 patients (4%) and 2 patients (2%), respectively. All patients with major bleeding had pericardial bleeding. CONCLUSIONS: The use of dabigatran in patients with mechanical heart valves was associated with increased rates of thromboembolic and bleeding complications, as compared with warfarin, thus showing no benefit and an excess risk. (Funded by Boehringer Ingelheim; ClinicalTrials.gov numbers, NCT01452347 and NCT01505881.).
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“VKAs are currently the only treatment with established safety in AF patients with rheumatic mitral valve disease and/or a mechanical heart valve prosthesis.400”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [400]
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“The use of an NOAC in patients with mechanical heart valves was associated with increased rates of thromboembolic and bleeding complications when compared with warfarain.(13) On the contrary, all ineligible patients with stroke needed anticoagulation therapy.”
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“However, DOACs are contraindicated in patients with a prosthetic mechanical valve because of the greater risk of potentially fatal valve thrombosis [33, 34].”
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“As for patients with mechanical valves, NOACs are clearly contraindicated based on the findings from the REALIGN (Randomized Phase II Study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate of Patients After Heart Valve Replant) trial in which the use of dabigatran in patients with mechanical he…”
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“VKAs efficacy and safety have been established over time and all over the world by several studies [17,18], and currently represent the first-choice treatment in AF patients with rheumatic mitral valve disease and/or a mechanical heart valve prosthesis [19].”
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“Accordingly, several guidelines recommend anticoagulation to prevent stroke in AF and prefer the use of the DOACs over VKAs in most patients (35); a notable exception include AF patients with mechanical heart valve, in whom DOACs are contraindicated and warfarin is still preferred based on data from the RE-ALIGN trial…”
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Warfarin related nephropathy: a case report and review of the literature
Ng, C. Y., Tan, C. S., Chin, C. T., Lim, S. L., Zhu, L., Woo, K. T., & Tan, P. H. (2016) · BMC Nephrology · doi:10.1186/s12882-016-0228-4 · Cited by 24
Pollari, F., Fischlein, T. J. M., Fittkau, M., & Santarpino, G. (2015) · Journal of Thoracic and Cardiovascular Surgery · doi:10.1016/j.jtcvs.2015.10.059 · Cited by 24
Detecting and managing device leads inadvertently placed in the left ventricle
Trohman, R. G., & Sharma, P. S. (2018) · Cleveland Clinic Journal of Medicine · doi:10.3949/ccjm.85a.17012 · Cited by 24
Anticoagulation for Mechanical Heart Valves
Chan, N., Weitz, J. I., & Eikelboom, J. W. (2017) · Arteriosclerosis Thrombosis and Vascular Biology · doi:10.1161/atvbaha.117.309223 · Cited by 24
Diseases of the Cardiovascular System
Lockhart, P. B., & Sun, Y. (2021) · Wiley eBooks · doi:10.1002/9781119597797.ch14 · Cited by 27
Factor XI Inhibitors: A New Horizon in Anticoagulation Therapy
Presume, J., Ferreira, J., & Ribeiras, R. (2024) · Cardiology and Therapy · doi:10.1007/s40119-024-00352-x · Cited by 26
Current Antithrombotic Treatments for Cardiovascular Diseases: A Comprehensive Review
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The Year in Cardiology 2013: valvular heart disease (focus on catheter-based interventions)
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Al-Abcha, A. K., Saleh, Y., Elsayed, M., Elshafie, A. H., Herzallah, K., Baloch, Z. Q., Banga, S., Rayamajhi, S., & Abela, G. S. (2021) · Cardiovascular revascularization medicine · doi:10.1016/j.carrev.2021.04.019 · Cited by 23
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“predominantly contact-pathway mediated and where DOAC use has appeared to be inferior to warfarin [36].”
BackgroundDOACs in the Anticoagulation of Mechanical Valves: A Systematic Review and Future Perspectives
Langenaeken, T., Vanoppen, A., Janssens, F., Tanghe, L., Verbrugghe, P., Rega, F., & Meuris, B. (2023) · Journal of Clinical Medicine · doi:10.3390/jcm12154984 · Cited by 23
Changing Practice of Anticoagulation: Will Target-Specific Anticoagulants Replace Warfarin?
Arepally, G. M., & Ortel, T. L. (2015) · Annual Review of Medicine · doi:10.1146/annurev-med-051113-024633 · Cited by 25
Alkherayf, F. A., Xu, Y., Gándara, E., Westwick, H. J., Moldovan, I. D., & Wells, P. S. (2016) · Thrombosis Research · doi:10.1016/j.thromres.2016.06.014 · Cited by 23
Bleeding in continuous flow left ventricular assist device recipients: an acquired vasculopathy?
Patel, S. R., Vukelic, S., & Jorde, U. P. (2016) · Journal of Thoracic Disease · doi:10.21037/jtd.2016.10.81 · Cited by 23
Liu, R., Cao, J., Zhang, Q., Shi, X., Pan, X., & Dong, R. (2017) · Medicine · doi:10.1097/md.0000000000005658 · Cited by 23
Maikranz, V., Siebenhofer, A., Ulrich, L.-R., Mergenthal, K., Schulz-Rothe, S., Kemperdick, B., Rauck, S., Pregartner, G., Berghold, A., Gerlach, F. M., et al. (2017) · BMC Family Practice · doi:10.1186/s12875-017-0588-2 · Cited by 23
Resumption of Anticoagulation After Intracranial Hemorrhage
da Silva, I. R. F., & Frontera, J. A. (2017) · Current Treatment Options in Neurology · doi:10.1007/s11940-017-0477-y · Cited by 24
Management of Anticoagulation in Patients With Prostate Cancer Receiving Enzalutamide
Shatzel, J. J., Daughety, M. M., Olson, S. R., Beer, T. M., & DeLoughery, T. G. (2017) · Journal of Oncology Practice · doi:10.1200/jop.2017.022004 · Cited by 23
Comuth, W., Henriksen, L. Ø., van de Kerkhof, D., Husted, S., Kristensen, S. D., de Maat, M. P. M., & Münster, A. B. (2018) · Thrombosis Research · doi:10.1016/j.thromres.2018.02.141 · Cited by 23
Martin, A., Godiér, A., Narayanan, K., Smadja, D. M., & Marijon, É. (2018) · Circulation · doi:10.1161/circulationaha.117.033326 · Cited by 23
Warfarin in patients with mechanical heart valves
Catterall, F., Ames, P. R. J., & Isles, C. (2020) · BMJ · doi:10.1136/bmj.m3956 · Cited by 23
Compensatory caspase activation in MPP+-induced cell death in dopaminergic neurons
Chee, J. L. Y., Guan, X. L., Lee, J. Y., Dong, B., Leong, S. M., Ong, E. H., Liou, A. K. F., & Lim, T. M. (2005) · Cellular and Molecular Life Sciences · doi:10.1007/s00018-004-4413-4 · Cited by 23
New targets for antithrombotic medications: seeking to decouple thrombosis from hemostasis
Barnes, G. D. (2024) · Journal of Thrombosis and Haemostasis · doi:10.1016/j.jtha.2024.12.003 · Cited by 22
Only high levels of dabigatran attenuate catheter thrombosis in vitro and in rabbits
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Management of Venous Thromboembolism
Finks, S. W., Trujillo, T. C., & Dobesh, P. P. (2016) · Annals of Pharmacotherapy · doi:10.1177/1060028016632785 · Cited by 22
Scherman, J., Manganyi, R., Human, P., Pennel, T. C., Brooks, A., Brink, J., & Zilla, P. (2018) · Journal of Thoracic and Cardiovascular Surgery · doi:10.1016/j.jtcvs.2018.06.083 · Cited by 22
Pastori, D., Lip, G. Y. H., Poli, D., Antonucci, E., Rubino, L., Menichelli, D., Saliola, M., Violi, F., Palareti, G., & Pignatelli, P. (2020) · British Journal of Haematology · doi:10.1111/bjh.16528 · Cited by 22
“…RE-ALIGN (Dabigatran short report First published online 20 February 2020 doi: 10.1111/bjh.16528 ª 2020 British Society for Haematology and John Wiley & Sons Ltd British Journal of Haematology, 2020, 190, 588–593 Etexilate in Patients With Mechanical Heart Valves) trial (Eikelboom et al., 2013).”
BackgroundInfluentialFaroux, L., Cruz‐González, I., Arzamendi, D., Freixa, X., y, L. N.-F., Peral, V., Caneiro‐Queija, B., Mangieri, A., Trejo‐Velasco, B., Asmarats, L., et al. (2021) · International Journal of Cardiology · doi:10.1016/j.ijcard.2021.02.054 · Cited by 22
Matchar, D. B., Love, S. R., Jacobson, A. K., Edson, R., Uyeda, L., Phibbs, C. S., & Dolor, R. J. (2014) · Journal of Thrombosis and Thrombolysis · doi:10.1007/s11239-014-1128-8 · Cited by 22
“Despite the development of new oral anticoagulants, such as those targeting thrombin (dabigatran etexilate) and factor Xa (rivaroxaban and apixaban), warfarin remains the medication of choice for patients with MHV [6].”
BackgroundNavigating the choice of oral anticoagulation therapy for atrial fibrillation in the NOAC era
Hammersley, D. J., & Signy, M. (2017) · Therapeutic Advances in Chronic Disease · doi:10.1177/2040622317720106 · Cited by 22
Metadata
- Authors
- Eikelboom, J. W., Connolly, S. J., Brueckmann, M., Granger, C. B., Kappetein, A. P., Mack, M. J., Blatchford, J., Devenny, K., Friedman, J., Guiver, K., Harper, R., Khder, Y., Lobmeyer, M. T., Maas, H., Voigt, J.-U., Simoons, M. L., & Van de Werf, F.
- Affiliations
- Hamilton Health Sciences (CA)
- Boehringer Ingelheim (Germany) (DE)
- Duke University (US)
- Erasmus MC (NL)
- Heart Hospital Baylor Plano (US)
- Boehringer Ingelheim (United Kingdom) (GB)
- Boehringer Ingelheim (United States) (US)
- Boehringer Ingelheim (France) (FR)
- KU Leuven (BE)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2013-09-26
- Volume
- 369
- Issue
- 13
- Pages
- 1206-1214
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2016875529
- Cited by
- 1,506
- References
- 27
- Citations by year
- 2026: 52 · 2025: 84 · 2024: 111 · 2023: 95 · 2022: 102 · 2021: 140 · 2020: 130 · 2019: 113 · 2018: 119 · 2017: 128 · 2016: 116 · 2015: 131 · 2014: 147 · 2013: 36
- FWCI
- 97.35
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Valve Diseases and Treatments
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Keywords
- dabigatran, warfarin, mechanical heart valves, direct thrombin inhibitors, anticoagulation, thromboembolism, bleeding complications, pericardial bleeding, stroke, aortic valve replacement, mitral valve replacement, dose adjustment
- MeSH terms
- Dabigatran, Aged, Anticoagulants, Atrial Fibrillation, Benzimidazoles, Female, Heart Valve Prosthesis, Hemorrhage, Humans, Male, Middle Aged, Thromboembolism, Warfarin, beta-Alanine, Stroke
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