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Risk of Bleeding With 2 Doses of Dabigatran Compared With Warfarin in Older and Younger Patients With Atrial Fibrillation: An Analysis of the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) Trial
Open accessAbstract
BACKGROUND: Dabigatran 150 and 110 mg twice a day and warfarin are effective for stroke prevention in atrial fibrillation. The purpose of this study was to compare their risks of bleeding in the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial. METHODS AND RESULTS: The RE-LY trial randomized 18 113 patients to receive dabigatran 110 or 150 mg twice a day or warfarin dose adjusted to an international normalized ratio of 2.0 to 3.0 for a median follow-up of 2.0 years. Compared with warfarin, dabigatran 110 mg twice a day was associated with a lower risk of major bleeding (2.87% versus 3.57%; P=0.002), whereas dabigatran 150 mg twice a day was associated with a similar risk of major bleeding (3.31% versus 3.57%; P=0.32). There was a significant treatment-by-age interaction, such that dabigatran 110 mg twice a day compared with warfarin was associated with a lower risk of major bleeding in patients aged <75 years (1.89% versus 3.04%; P<0.001) and a similar risk in those aged ≥75 years (4.43% versus 4.37%; P=0.89; P for interaction <0.001), whereas dabigatran 150 mg twice a day compared with warfarin was associated with a lower risk of major bleeding in those aged <75 years (2.12% versus 3.04%; P<0.001) and a trend toward higher risk of major bleeding in those aged ≥75 years (5.10% versus 4.37%; P=0.07; P for interaction <0.001). The interaction with age was evident for extracranial bleeding, but not for intracranial bleeding, with the risk of the latter being consistently reduced with dabigatran compared with warfarin irrespective of age. CONCLUSIONS: In patients with atrial fibrillation at risk for stroke, both doses of dabigatran compared with warfarin have lower risks of both intracranial and extracranial bleeding in patients aged <75 years. In those aged ≥75 years, intracranial bleeding risk is lower but extracranial bleeding risk is similar or higher with both doses of dabigatran compared with warfarin. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00262600.
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“The risk of gastrointestinal bleeds was comparable to warfarin on dabigatran 110 mg twice daily 490 and on apixaban 5 mg twice daily 319”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [490]
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“Compared with warfarin, the risk of gastrointestinal bleeds was increased for dabigatran 150 mg twice daily, 396, 490 rivaroxaban 20 mg once daily, 491 and edoxaban 60 mg once daily.321”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [490]
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Dabigatran‐Induced Hyperkalemia in a Renal Transplant Recipient: A Clinical Observation
Zaleski, M., Dabage, N., Paixao, R. C., & Muniz, J. R. C. (2013) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.21 · Cited by 9
Dabigatran Excess: Case Report and Review of the Literature
Sarma, A. A., Rossi, J., Connors, J. M., & Giugliano, R. P. (2013) · Cardiology and Therapy · doi:10.1007/s40119-013-0016-1 · Cited by 9
Dabigatran: A Primer for Neurosurgeons
Fugate, J. E., Rabinstein, A. A., McBane, R. D., & Lanzino, G. S. (2012) · World Neurosurgery · doi:10.1016/j.wneu.2012.06.019 · Cited by 9
Preventive Strategies against Bleeding due to Nonvitamin K Antagonist Oral Anticoagulants
Lessire, S., Dincq, A.-S., Douxfils, J., Devalet, B., Nicolas, J., Anne, S., Larock, A., Jean-Michel, D., Gourdin, M. J., & Mullier, F. (2014) · BioMed Research International · doi:10.1155/2014/616405 · Cited by 9
“Based on the RE-LY trial, DE 150mg BID, combined with a single or dual antiplatelet therapy, increased the rate of extracranial bleeding [35].”
MethodMinno, M. N. D. D., Ambrosino, P., Minno, A. D., Tremoli, E., & Minno, G. D. (2017) · Annals of Medicine · doi:10.1080/07853890.2016.1268710 · Cited by 9
“Accordingly, several sub-studies and meta-analyses have been performed to assess the safety and efficacy of NOACs in these specific clinical settings (13–23).”
BackgroundInfluentialLeft atrial appendage occlusion
Nietlispach, F., Moarof, I., Taramasso, M., Maisano, F., & Meier, B. (2017) · EuroIntervention · doi:10.4244/eij-d-17-00412 · Cited by 11
A 79-Year-Old Woman with Atrial Fibrillation and New Onset of Heart Failure
Schneider, B., Nazarenus, D., & Stöllberger, C. (2019) · ESC Heart Failure · doi:10.1002/ehf2.12435 · Cited by 9
“OAC for stroke prevention has the disadvantage of bleeding complications especially in older patients and in those with low body weight.(7) Most probably, the bleeding events in our patient resulted from overanticoagulation by prescribing standard anticoagulant doses for this small and underweight lady.”
BackgroundConti, A., Renzi, N., Catarzi, S., Mazzucchelli, M., Covelli, A., Pampana, A., Bongini, G., Bini, G., Leorin, M., & Ghiadoni, L. (2020) · Critical Pathways in Cardiology A Journal of Evidence-Based Medicine · doi:10.1097/hpc.0000000000000205 · Cited by 9
Kitamura, T., Torii, S., Hanayama, N., Oka, N., Tomoyasu, T., Irisawa, Y., Shibata, M., Hayashi, H., INOUE, T., & Miyaji, K. (2013) · International Heart Journal · doi:10.1536/ihj.54.11 · Cited by 9
Fox, K. A. A., White, H. D., Gersh, B. J., & Opie, L. H. (2013) · Elsevier eBooks · doi:10.1016/b978-1-4557-3322-4.00018-1 · Cited by 9
Warfarin After Bioprosthetic Aortic Valve Implantation
Mehta, S. R., & Weitz, J. I. (2012) · JAMA · doi:10.1001/jama.2012.91476 · Cited by 9
Xu, Y., Bechler, K., Callahan, A., & Shah, N. H. (2023) · Journal of Biomedical Informatics · doi:10.1016/j.jbi.2023.104420 · Cited by 9
Yamashita, T., Igawa, Y., Fukuzawa, M., Hayashi, T., Hennig, S., & Okumura, K. (2024) · Thrombosis and Haemostasis · doi:10.1055/s-0044-1785511 · Cited by 8
“15 Although the present PK data show a slightly lower plasma concentration with edoxaban 15 mg than the plasma concentration observed with the usual edoxaban dose in the elderly population in the ENGAGE AF-TIMI 48 study, 16 the incidences of stroke/systemic embolic events and major bleeding were…”
Impaired renal function and bleeding in elderly treated with dabigatran
Berthelot, E., Lavenu‐Bombled, C., Orostegui, L., Desconclois, C., & Assayag, P. (2014) · Blood Coagulation & Fibrinolysis · doi:10.1097/mbc.0000000000000077 · Cited by 8
Cafolla, A., Campanelli, M., Baldacci, E., Potasso, L., Bochicchio, R. A., Dragoni, F., & Foà, R. (2012) · European Journal Of Haematology · doi:10.1111/j.1600-0609.2012.01786.x · Cited by 8
“The RE-LY study showed the efficacy and safety of dabigatran etexilate, a new oral direct thrombin inhibitor, for stroke prevention in patients with AF aged 75 and older (24), but the higher risk of extracranial bleeding with dabigatran compared with dose-adjusted warfarin (PT/INR target 2,5) has been reported in pati…”
BackgroundLee, A., & Rajaratnam, R. (2014) · Journal of Neurology & Neurophysiology · doi:10.4172/2155-9562.1000248 · Cited by 8
Ghadban, R., Flaker, G., Katta, N., & Alpert, M. (2017) · Hemodialysis International · doi:10.1111/hdi.12600 · Cited by 8
Navas‐Blanco, J. R., Martini, A., & Fabbro, M. (2021) · Journal of Cardiothoracic and Vascular Anesthesia · doi:10.1053/j.jvca.2021.02.024 · Cited by 9
Novel anticoagulants in the management of atrial fibrillation: A comprehensive comparative analysis
Jwaid, M. M., Alwan, M. J., Ihsan, I., Jwaid, M. M., Muhsin, Y. F., Al-Hussaniy, H. A., & Iraqi, M. (2024) · Pharmacia · doi:10.3897/pharmacia.555.e113097 · Cited by 8
Vincentis, A. D., Soraci, L., Arena, E., Sciacqua, A., Armentaro, G., Aucella, F., Corsonello, A., Aucella, F., & Incalzi, R. A. (2024) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.16010 · Cited by 8
“23,24 According to our data, much more attention should be directed to the choice of the most suitable DOAC in this specific population, in order to provide the optimal balance between thromboembolic and bleeding risk.”
BackgroundKaku, S., Uemura, T., Saitoh, M., Suzuki, K., Iwatsuki, Y., Funatsu, T., & Kawasaki, T. (2012) · European Journal of Pharmacology · doi:10.1016/j.ejphar.2012.11.026 · Cited by 8
“: þ81 29 852 2955. any new oral anticoagulant should have a wider safety margin than currently available drugs (Eikelboom et al., 2011).”
BackgroundUpdate on the Clinical Management of Atrial Fibrillation: Guidelines and Beyond
Curtis, A. B. (2011) · Postgraduate Medicine · doi:10.3810/pgm.2011.11.2491 · Cited by 9
“extracranial bleeding risk was similar or higher with both doses of dabigatran compared with warfarin.(49)”
BackgroundMischke, K., Knackstedt, C., & Marx, N. (2012) · Thrombosis · doi:10.1155/2012/184573 · Cited by 8
Liew, A., & Douketis, J. D. (2013) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.2013.770838 · Cited by 8
“On the other hand, both doses of dabigatran when compared with warfarin conferred significantly lower risks of intracranial bleeding, irrespective of patient age and the quality of INR control [33].”
Background
Metadata
- Authors
- Eikelboom, J. W., Wallentin, L., Connolly, S. J., Ezekowitz, M., Healey, J. S., Oldgren, J., Yang, S., Alings, M., Kaatz, S., Hohnloser, S. H., Diener, H.-C., Franzosi, M. G., Huber, K., Reilly, P., Varrone, J., & Yusuf, S.
- Affiliations
- Goethe University Frankfurt (DE)
- ORCID
- Venue
- Circulation
- Published
- 2011-05-31
- Volume
- 123
- Issue
- 21
- Pages
- 2363-2372
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2064357176
- Cited by
- 1,081
- References
- 16
- Citations by year
- 2026: 11 · 2025: 17 · 2024: 21 · 2023: 20 · 2022: 36 · 2021: 43 · 2020: 64 · 2019: 61 · 2018: 56 · 2017: 77 · 2016: 95 · 2015: 121 · 2014: 99 · 2013: 167 · 2012: 156
- FWCI
- 100.82
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Health Sciences › Medicine › Clinical Neurology › Acute Ischemic Stroke Management
- Keywords
- dabigatran, warfarin, atrial fibrillation, major bleeding, intracranial hemorrhage, extracranial hemorrhage, stroke prevention, anticoagulation, elderly patients, age interaction, RE-LY trial, direct thrombin inhibitors, dose comparison, international normalized ratio, bleeding risk stratification, bleeding risk prediction model
- MeSH terms
- Dabigatran, Age Factors, Aged, Aged, 80 and over, Anticoagulants, Atrial Fibrillation, Benzimidazoles, Drug Administration Schedule, Female, Hemorrhage, Humans, Male, Middle Aged, Risk Factors, Time Factors, Warfarin, beta-Alanine
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