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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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MethodResultTratamiento antitrombótico en el paciente anciano con fibrilación auricular
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“According to event probabilities [16,17,28,29], patients move into the Markov mode l through the following health states: no major event, major hemorrhagic event, major thromboembolic event, and death (Figure 2).”
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MethodMajeed, A., Hwang, H.-G., Eikelboom, J. W., Connolly, S. J., Wallentin, L. C., Feuring, M., Brueckmann, M., Noack, H., Yusuf, S., & Schulman, S. (2016) · Thrombosis Research · doi:10.1016/j.thromres.2016.02.005 · Cited by 15
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BackgroundMethodChinese Guidelines for the Diagnosis and Management of Atrial Fibrillation
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“Since RE-LY, numerous subgroup analyses have examined safety in patient cohorts isolating certain risk factors including renal dysfunction, heart failure, older age, and a higher CHADS2 score, and all have demonstrated similar safety to warfarin (14-22).”
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“Also in the RE-LY study, which compared dabigatran with warfarin, patients aged[75 years had a higher bleeding rate, especially gastrointestinal bleedings, than warfarin-treated patients [21].”
MethodResultNon-Vitamin K Oral Anticoagulants in Stroke Patients: Practical Issues
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“As shown before, also in our study, in the vast majority, predominated lower GIB [44] possible by incomplete absorption of the active substance in the upper tract and increased NOACs availability in the lower tract [45].”
ResultHalperin, J. L., & Dorian, P. (2014) · Current Cardiology Reviews · doi:10.2174/1573403x10666140513104523 · Cited by 13
“, but the relative increase in bleeding risk was similar for both drugs [25] Dabigatran is approximately 80% excreted via the renal route, and higher concentrations of the drug accumulate in the blood of patients with renal dysfunction [26].”
Dabigatran-Associated Intracranial Hemorrhage
King, A. E., Szarlej, D., & Rincón, F. (2015) · The Neurohospitalist · doi:10.1177/1941874415569069 · Cited by 14
Percutaneous left atrial appendage closure for stroke prevention in atrial fibrillation
Swaans, M. J., Post, M. C., Rensing, B. J. W. M., & Boersma, L. V. A. (2012) · Netherlands Heart Journal · doi:10.1007/s12471-011-0236-8 · Cited by 14
“Additional drawbacks include higher drug costs, accumulation in case of renal impairment, and high discontinuation rates due to adverse events [23, 24].”
BackgroundLaboratory Assessment of the Anticoagulant Activity of Dabigatran
Kyriakou, E. S., Ikonomidis, I., Stylos, D., Bonovas, S., Papadakis, I., Nikolopoulos, G. K., Kokoris, S. I., Kalantzis, D., Economopoulou, C., Kopterides, P., et al. (2014) · Clinical and Applied Thrombosis/Hemostasis · doi:10.1177/1076029614564209 · Cited by 14
Meschia, J. F., Bushnell, C., Boden-Albala, B. M., Braun, L. T., Bravata, D. M., Chaturvedi, S., Creager, M. A., Eckel, R. H., Fornage, M., Goldstein, L. B., et al. (2014) · Cited by 15
Butkiewicz, M., RESTREPO, N. A., Haines, J. L., & Crawford, D. C. (2016) · PubMed Central · Cited by 14
Nantsupawat, T., Soontrapa, S., Nantsupawat, N., Sotello, D., Klomjit, S., Adabağ, S., & Perez‐Verdia, A. (2017) · Journal of Arrhythmia · doi:10.1002/joa3.12015 · Cited by 14
“From the RE-LY trial, 53% of major GIB occurred in the lower GI tract and 47% occurred in the upper GI tract.(7) There are limited data regarding effective strategy to reduce GIB among dabigatran users.”
BackgroundEpistaxis complicating treatment by anti-vitamin K and new oral anticoagulants
L’Huillier, V., Badet, C., & Tavernier, L. (2018) · European Annals of Otorhinolaryngology Head and Neck Diseases · doi:10.1016/j.anorl.2018.04.006 · Cited by 14
Grymonprez, M., Vanspranghe, K., Steurbaut, S., de Backer, T. L., & Lahousse, L. (2021) · Cardiovascular Drugs and Therapy · doi:10.1007/s10557-021-07279-8 · Cited by 14
Hohnloser, S. H., & Connolly, S. J. (2011) · European Heart Journal · doi:10.1093/eurheartj/ehr344 · Cited by 14
Ткачева, О. Н., Vorobyeva, N. M., Kotovskaya, Y. V., Рунихина, Н. К., Strazhesko, I. D., Вадимовна, В. С., Drapkina, O. M., Komarov, A. L., Orlova, Y. A., Панченко, Е. П., et al. (2021) · CARDIOVASCULAR THERAPY AND PREVENTION · doi:10.15829/1728-8800-2021-2847 · Cited by 14
Jeong, J., Heo, K., Lee, S., Ah, Y., Min, S., Han, J. M., & Lee, J. (2024) · Frontiers in Pharmacology · doi:10.3389/fphar.2024.1399955 · Cited by 13
Chin, P. K. L., Vella-Brincat, J., Walker, S. L., Barclay, M. L., & Begg, E. J. (2013) · Internal Medicine Journal · doi:10.1111/imj.12170 · Cited by 13
Antiplatelet Therapy in Cerebrovascular Disorders
Weber, R., Brenck, J., & Diener, H. (2012) · Handbook of experimental pharmacology · doi:10.1007/978-3-642-29423-5_21 · Cited by 14
Hernandez, I., Zhang, Y., & Saba, S. (2018) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2018.03.012 · Cited by 13
Туров, А. Н., Panfilov, S. V., & Tschiglinzeva, О. V. (2020) · Rational Pharmacotherapy in Cardiology · doi:10.20996/1819-6446-2020-20-07 · Cited by 13
Patti, G., & Haas, S. K. (2020) · Journal of Cardiovascular Pharmacology · doi:10.1097/fjc.0000000000000927 · Cited by 13
Bouchnita, A., Nony, P., Llored, J.-P. N., & Volpert, V. A. (2022) · Mathematical Biosciences · doi:10.1016/j.mbs.2022.108830 · Cited by 13
Sia, J. E. V., Lai, X., Wu, X., Zhang, F., Li, H., Cui, C., & Liu, D. (2023) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2023.106376 · Cited by 13
“Compared to the younger patients, the drug-related gastrointestinal bleeding risk of older adults on dabigatran was higher than that of warfarin (Eikelboom et al., 2011).”
La anticoagulación oral en el anciano con fibrilación auricular no valvular
Fernández, F. V., Jiménez, M. D. R. M., Cerviño, S. M. B., & Losada, M. D. M. M. (2015) · Revista Española de Geriatría y Gerontología · doi:10.1016/j.regg.2015.01.005 · Cited by 13
Brunetti, L., Sanchez-Catanese, B., Kagan, L., Wen, X., Liu, M., Buckley, B., Luyendyk, J. P., & Aleksunes, L. M. (2016) · Thrombosis Journal · doi:10.1186/s12959-016-0084-2 · Cited by 13
Gastrointestinal bleeding secondary to the new anticoagulants
Abraham, N. S., & Horsley‐Silva, J. L. (2016) · Current Opinion in Gastroenterology · doi:10.1097/mog.0000000000000310 · Cited by 13
“Blatchford score al impairment CrCl (ml/min) DO Dabigatran (mg BID) Rivaroxaba erate 30–50 150 1 re 15–30 75 1 creatinine clearance; DOAC, direct oral anticoagulant.”
BackgroundInfluentialFoody, J. M. (2017) · Clinical Interventions in Aging · doi:10.2147/cia.s111216 · Cited by 15
Anticoagulation in frail older people.
Damanti, S., Braham, S., & Pasina, L. (2019) · Europe PMC (PubMed Central) · doi:10.11909/j.issn.1671-5411.2019.11.005 · Cited by 13
Routine Repeat Head CT Does Not Change Management in Trauma Patients on Novel Anticoagulants
Cohan, C. M., Beattie, G., Dominguez, D. A., Glass, M., Palmer, B. J. A., & Victorino, G. P. (2020) · Journal of Surgical Research · doi:10.1016/j.jss.2019.11.009 · Cited by 13
Anti-thrombotic therapy in patients with atrial fibrillation and intracranial hemorrhage
Diener, H.-C., Stanford, S., Abdul-Rahim, A., Christensen, L., Hougaard, K. D., Bakhai, A., Veltkamp, R., & Worthmann, H. (2014) · Expert Review of Neurotherapeutics · doi:10.1586/14737175.2014.945435 · Cited by 12
“compared with warfarin [44], but again even the older patients recruited are more likely to have had a healthier clinical trial bias.”
Incorporating edoxaban into the choice of anticoagulants for atrial fibrillation
Eikelboom, J. W., & Weitz, J. I. (2015) · Thrombosis and Haemostasis · doi:10.1160/th15-02-0181 · Cited by 12
A randomised, double blind comparison of tecarfarin, a novel vitamin K antagonist, with warfarin
Whitlock, R. P., Fordyce, C. B., Midei, M. G., Ellis, D. J., Garcia, D. A., Weitz, J. I., Canafax, D. M., Albrecht, D., & Milner, P. G. (2016) · Thrombosis and Haemostasis · doi:10.1160/th15-11-0910 · Cited by 12
Suceveanu, A., Suceveanu, A., Parepa, I. R., Mazilu, L., Stoian, A. P., Diaconu, C. C., Botea, F., Herlea, V., Micu, S. I., Tuta, L. A., et al. (2020) · Experimental and Therapeutic Medicine · doi:10.3892/etm.2020.9335 · Cited by 13
“RE‐LY trial confirmed the presence of UDB in 47% of patients with dabigatran, indicating that other hemorrhagic mechanisms involving dabigatran use are hypothesized (12).”
BackgroundVerma, L. A., Penson, P. E., Akpan, A., Lip, G. Y. H., & Lane, D. A. (2023) · Expert Review of Cardiovascular Therapy · doi:10.1080/14779072.2023.2276892 · Cited by 12
“…risk assessment, incorporating personal preference and the process of shared decision making should be followed The efficacy and safety of NOACs vs. warfarin in people aged ≥75 years has been verified by secondary analyses of data from the original Phase III NOAC RCTs [23–26, 32 –36 ] ( Table 1).”
BackgroundMethodInfluential
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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