Cited by 1,506Atrial Fibrillation Management and OutcomesCardiac Valve Diseases and TreatmentsVenous Thromboembolism Diagnosis and Management

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Dabigatran versus Warfarin in Patients with Mechanical Heart Valves

Eikelboom, John W., Connolly, Stuart J., Brueckmann, Martina, Granger, Christopher B., Kappetein, Arie P., Mack, Michael J., Blatchford, Jon, Devenny, Kevin, Friedman, Jeffrey, Guiver, Kelly, Harper, Ruth, Khder, Yasser, Lobmeyer, Maximilian T., Maas, Hugo, Voigt, Jens-Uwe, Simoons, Maarten L., Van de Werf, Frans·2013·New England Journal of Medicine

DOI 10.1056/nejmoa1300615

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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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Gulpen, A. J. W., ten Cate‐Hoek, A. J., & Cate, H. T. (2016) · Expert Review of Cardiovascular Therapy · doi:10.1080/14779072.2016.1224179 · Cited by 8
International normalized ratio (INR) values in patients receiving oral vitamin K antagonists and undergoing oral surgery: A clinical audit
Lombardi, N., Varoni, E. M., Sorrentino, D., & Lodi, G. (2020) · Special Care in Dentistry · doi:10.1111/scd.12485 · Cited by 8
Direct oral anticoagulants versus vitamin K antagonists in the first 3 months after bioprosthetic valve replacement: a systematic review and meta-analysis
Eikelboom, R., Whitlock, R. P., Muzaffar, R., Lópes, R. D., Siegal, D. M., Schulman, S., & Belley‐Côté, E. P. (2023) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezad110 · Cited by 8
Direct oral anticoagulants versus vitamin K antagonist after transcatheter aortic valve implantation
Hohmann, C., Pfister, R., Frerker, C., Beckmann, A., Walther, T., Bleiziffer, S., Ensminger, S. M., Bekeredjian, R., Seiffert, M., Sinning, J., et al. (2023) · Heart · doi:10.1136/heartjnl-2023-322548 · Cited by 8
Design and Rationale for the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices (DOAC LVAD) Study
Dimond, M. G., Looby, M., Shah, B., Sinha, S. S., Isseh, I. N., Rollins, A., Abdul-Aziz, A. A., Kennedy, J. L. W., Tang, D. G., Klein, K. M., et al. (2023) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2023.10.473 · Cited by 8
Anticoagulation for the acute management of ischemic stroke.
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Atrial Fibrillation: A Review of Recent Studies with a Focus on Those from the Duke Clinical Research Institute
Rao, M. P., Pokorney, S. D., & Granger, C. B. (2014) · Scientifica · doi:10.1155/2014/901586 · Cited by 9
Warfarin versus dabigatran etexilate: an assessment of efficacy and safety in patients with atrial fibrillation
Dzeshka, M. S., & Lip, G. Y. H. (2014) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2015.973847 · Cited by 8
Prevention and treatment of venous thromboembolism in patients with cancer
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Lessons from the RE-ALIGN trial
Iung, B., & Vahanian, A. S. (2014) · Archives of cardiovascular diseases · doi:10.1016/j.acvd.2014.02.002 · Cited by 8
“However, the presentation of the results of the Randomized, Phase II Study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients after Heart Valve Replacement (RE-ALIGN) at the annual congress of the European Society of Cardiology in September 2013, followed by their publication, was dis…”
Background
Dabigatran for the prevention and treatment of thromboembolic disorders
Enriquez, A. A., Baranchuk, A. M., Redfearn, D., Simpson, C. S., Abdollah, H., & Michael, K. (2015) · Expert Review of Cardiovascular Therapy · doi:10.1586/14779072.2015.1034692 · Cited by 8
Problems in anticoagulation of a patient with antibiotic treatment for endocarditis: interaction of rifampicin and vitamin K antagonists
Mizera, L., Geisler, T., Mörike, K., Gawaz, M., & Steeg, M. (2018) · BMJ Case Reports · doi:10.1136/bcr-2016-215155 · Cited by 8
Classification and characteristics of on‐label and off‐label apixaban use in Denmark and Sweden
Vinter, N., Linder, M., Andersen, M. T., Pedersen, A. B., Madsen, M., Schachterle, S. E., Ataher, Q., Mo, J., Johnsen, S. P., & Ehrenstein, V. (2019) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.4778 · Cited by 8
“Off‐label use of NOACs is of particular concern in patients with mechanical heart valves, where a higher risk of thrombotic and bleeding complications has been found compared with warfarin.(40,41) The evidence of the effect of NOACs in patients with other heart valve disorders is also limited.”
Result
Oral anticoagulant monitoring: Are we on the right track?
Onundarson, P. T., & Flygenring, B. (2019) · International Journal of Laboratory Hematology · doi:10.1111/ijlh.13008 · Cited by 8
Influence of Direct Thrombin Inhibitor and Low Molecular Weight Heparin on Platelet Function in Patients with Coronary Artery Disease: A Prospective Interventional Trial
Arantes, F. B. B., Menezes, F. R., Franci, A., Barbosa, C., Dalçóquio, T. F., Nakashima, C. A. K., Baracioli, L. M., Furtado, R. H. M., Nomelini, Q. S. S., Ramires, J. A. F., et al. (2019) · Advances in Therapy · doi:10.1007/s12325-019-01153-8 · Cited by 10
Clinical classification and the subclinical atrial fibrillation challenge: a position paper of the European Cardiac Arrhythmia Society
Lévy, S., Santini, L., Cappato, R., Steinbeck, G., Capucci, A., & Saksena, S. V. (2020) · Journal of Interventional Cardiac Electrophysiology · doi:10.1007/s10840-020-00859-y · Cited by 9
Aortic valve replacement in younger adults: a biological valve is not the logical choice
Head, S. J., & Kappetein, A. P. (2015) · European Heart Journal · doi:10.1093/eurheartj/ehv644 · Cited by 8
Are Ticks the Answer to Medical Device-Associated Clotting?
Weitz, J. I., & Chan, N. (2019) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.08.1027 · Cited by 8
Update on Perioperative Antithrombotic Management
Boschitz, D., Fastowiec, D. M., & Bolliger, D. (2024) · Current anesthesiology reports · doi:10.1007/s40140-024-00633-0 · Cited by 7
Direct oral anticoagulants versus warfarin in adults with durable left ventricular assist devices: A systematic review and meta-analysis
Mhanna, M., Ayyad, M., Mortada, I., Al‐Abdouh, A., Jabri, A., Alharbi, A. A., Barbarawi, M., Beran, A., Duque, E. R., & Mansour, S. (2024) · Current Problems in Cardiology · doi:10.1016/j.cpcardiol.2024.102871 · Cited by 7
Effect of heparins, direct oral anticoagulants, and factor XII/factor XI inhibitors on catheter-initiated thrombin generation in platelet-rich plasma: an in vitro study
Hardy, M. J., Thonon, H., Douxfils, J., Vassart, J., Gouin‐Thibault, I., Lessire, S., Lecompte, T., & Mullier, F. (2025) · Journal of Thrombosis and Haemostasis · doi:10.1016/j.jtha.2025.06.016 · Cited by 7
Detecting nonvalvular atrial fibrillation and anticoagulant therapy in cardioembolic ischemic stroke
Min, J., & Farooq, M. U. (2016) · Postgraduate Medicine · doi:10.1080/00325481.2016.1195236 · Cited by 7
One Rare Warfarin Resistance Case and Possible Mechanism Exploration
Zhao, L. R., Zhai, Z., & Li, P. (2023) · Pharmacogenomics and Personalized Medicine · doi:10.2147/pgpm.s404474 · Cited by 7
Low-dose warfarin with a novel mechanical aortic valve: Interim registry results at 5-year follow-up
Gerdisch, M., Hagberg, R. C., Perchinsky, M. J., Joseph, M., Oo, A., Loubani, M., TSANG, G. M. K., Zacharias, J., & Sathyamoorthy, M. (2024) · Journal of Thoracic and Cardiovascular Surgery · doi:10.1016/j.jtcvs.2024.04.017 · Cited by 7
Evaluation of the safety and efficacy of direct oral anticoagulants compared with vitamin-k antagonists in the treatment of left ventricular thrombosis. A systematic review and meta-analysis
Mehrpooya, M., Barakzehi, M. R., & Nikoobakhsh, M. (2024) · Heart & Lung · doi:10.1016/j.hrtlng.2024.04.019 · Cited by 7
Future of factor XI inhibitors in cardiovascular practice
GRECO, A., Ammirabile, N., Landolina, D., Imbesi, A., Raffo, C., & Capodanno, D. (2024) · Minerva Cardiology and Angiology · doi:10.23736/s2724-5683.23.06474-8 · Cited by 8
Left Atrial Appendage Occlusion Addresses the Tremendous Unmet Needs of Stroke Prevention in Atrial Fibrillation That Persist Despite Recent Advances in Anticoagulation Therapy
Whisenant, B. K., Kar, S., & Bunch, T. J. (2014) · Circulation · doi:10.1161/circulationaha.114.008140 · Cited by 7
Dental Procedures in Patients with Atrial Fibrillation and New Oral Anticoagulants
Tsolka, P. (2014) · Arrhythmia & Electrophysiology Review · doi:10.15420/aer.2014.3.2.85 · Cited by 7
Monitoring of treatment with vitamin K antagonists: recombinant thromboplastins are more sensitive to factor VII than tissue‐extract thromboplastins
Biedermann, J. S., van den Besselaar, A. M. H. P., de Maat, M. P. M., Leebeek, F. W. G., & Kruip, M. (2017) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.13611 · Cited by 7
Anticoagulation Management After Transcatheter and Surgical Valve Replacement
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The year in cardiology 2014: arrhythmias and device therapy
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Non-vitamin K antagonist oral anticoagulants for stroke prevention in atrial fibrillation: safety issues in the elderly
Ajam, T., Cumpian, T. L., Tilkens, B. L., Jahangir, I. A., Frost, J., Ceretto, C., & Jahangir, A. (2020) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2020.1842191 · Cited by 7
Genetic Warfarin-Resistance Resulting in Surgery to Change a Prosthetic Valve
Malik, J., Ishaq, U., Javed, N., Baig, M. A., & Javaid, M. (2020) · European Journal of Case Reports in Internal Medicine · doi:10.12890/2020_001851 · Cited by 7

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: Eikelboom, John W.
Connolly, Stuart J.
Brueckmann, Martina
Granger, Christopher B.
Kappetein, Arie P.
Mack, Michael J.
Blatchford, Jon
Guiver, Kelly
Khder, Yasser
Lobmeyer, Maximilian T.
Voigt, Jens-Uwe
Simoons, Maarten L.
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
DOI: 10.1056/nejmoa1300615
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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Dabigatran versus Warfarin in Patients with Mechanical Heart Valves

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