Cited by 1,081Atrial Fibrillation Management and OutcomesVenous Thromboembolism Diagnosis and ManagementAcute Ischemic Stroke Management

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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

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Eikelboom, John W., Wallentin, Lars, Connolly, Stuart J., Ezekowitz, Mike, Healey, Jeff S., Oldgren, Jonas, Yang, Sean, Alings, Marco, Kaatz, Scott, Hohnloser, Stefan H., Diener, Hans-Christoph, Franzosi, Maria Grazia, Huber, Kurt, Reilly, Paul, Varrone, Jeanne, Yusuf, Salim·2011·Circulation

DOI 10.1161/circulationaha.110.004747

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Abstract

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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Background
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Lip, G. Y. H., Bongiorni, M. G., Dobreanu, D., Lewalter, T., Svendsen, J. H., & Blomström‐Lundqvist, C. (2013) · EP Europace · doi:10.1093/europace/eut292 · Cited by 21
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Pharmacogenetics of Antiplatelets and Anticoagulants: A Report on Clopidogrel, Warfarin and Dabigatran
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Antithrombotic Management of Atrial Fibrillation in the Elderly
Edholm, K., Ragle, N., & Rondina, M. T. (2015) · Medical Clinics of North America · doi:10.1016/j.mcna.2014.11.012 · Cited by 21
“The incidence of renal impairment increases with age, and renal impairment increases the risk of both TE and bleeding complications in patients with AF independent of other risk factors.(49,50) Because AF is primarily a disease of the elderly, these two conditions often coexist, leading to significant concerns about b…”
Background
Non–Vitamin K–Dependent Oral Anticoagulants for Nonvalvular Atrial Fibrillation in Patients With CKD: Pragmatic Considerations for the Clinician
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Off-label use of reduced dose direct oral factor Xa inhibitors in subjects with atrial fibrillation: a review of clinical evidence
Bo, M., Corsini, A., Brunetti, E., Isaia, G., Gibello, M., Ferri, N., Poli, D., Marchionni, N., & Ferrari, G. M. D. (2020) · European Heart Journal - Cardiovascular Pharmacotherapy · doi:10.1093/ehjcvp/pvaa103 · Cited by 21
Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) Versus Warfarin in Patients with Atrial Fibrillation and (Morbid) Obesity or Low Body Weight: a Systematic Review and Meta-Analysis
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Performance of the HAS‐BLED, ORBIT, and ATRIA Bleeding Risk Scores on a Cohort of 399 344 Hospitalized Patients With Atrial Fibrillation and Cancer: Data From the French National Hospital Discharge Database
Pastori, D., Marang, A., Bisson, A., Herbert, J., Lip, G. Y. H., & Fauchier, L. (2022) · Journal of the American Heart Association · doi:10.1161/jaha.121.026388 · Cited by 21
“29 This incidence was a bit higher in a real-world study, reaching 0.8%/year.”
Influential
Non-vitamin K oral anticoagulants in atrial fibrillation: Where are we now?
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Estimated glomerular filtration rate is associated with major bleeding complications but not thromboembolic events, in anticoagulated patients taking warfarin
Wieloch, M., Jönsson, K. M., Själander, A., Lip, G. Y. H., Eriksson, N., & Svensson, P. J. (2013) · Thrombosis Research · doi:10.1016/j.thromres.2013.01.006 · Cited by 21
“A >2-fold higher risk ofmajor bleedingwas evident in the RE-LY trial in patients on OAT with either dabigatran or warfarin with a creatinine clearance b50 ml/min, compared with those who had a clearance >80 mL/min [30], consistent with previous findings [15].”
BackgroundResult
Dabigatran Etexilate: An Oral Direct Thrombin Inhibitor for the Management of Thromboembolic Disorders
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Dosing challenges with direct oral anticoagulants in the elderly: a retrospective analysis
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Impact of renal function deterioration on adverse events during anticoagulation therapy using non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation
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“On the other hand, AF patients with impaired renal function are at higher risk for bleeding as well as thromboembolism compared with those with preserved renal function [7–12].”
BackgroundResultInfluential
Novel oral anticoagulants for stroke prevention in atrial fibrillation: a focus on the older patient
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“00% per year for warfarin).(62) Patients aged , 75 years had ICH rates of 0.”
Influential
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Update on the management of atrial fibrillation
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“In RE-LY, patients experienced similar rates of stroke/systemic embolism and ICH, regardless of age category [41].”
Background
The safety and efficacy of non-vitamin K antagonist oral anticoagulants in atrial fibrillation in the elderly
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Stroke prevention in atrial fibrillation
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“Thus, by balancing results of clinical trials, subanalysis and data from other studies [58,62,63], an attempt at identifying clinical and demographical characteristics of subjects to switch to DACs can be made (Table 5).”
Result
Assessing Bleeding Risk in Patients With Intentional Overdoses of Novel Antiplatelet and Anticoagulant Medications
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“org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Ag…”
Background
Stroke Prevention in Atrial Fibrillation: Understanding the New Oral Anticoagulants Dabigatran, Rivaroxaban, and Apixaban
San, T. R., Chan, M. Y., Teo, W. S., Tang, K. F., Siang, N. K., Lee, S. H., & Keong, C. C. (2012) · Thrombosis · doi:10.1155/2012/108983 · Cited by 18
“Some have been linked to use of dabigatran in elderly patients with severe renal impairment, a group that is known to have increased bleeding risk [59].”
Assessment of Aging-Related Function Variations of P-gp Transporter in Old-Elderly Chinese CHF Patients Based on Modeling and Simulation
Cui, C., Qu, Y., Sia, J. E. V., Zhu, Z., Wang, Y., Ling, J., Li, H., Jiang, Y., Pan, J., & Liu, D. (2022) · Clinical Pharmacokinetics · doi:10.1007/s40262-022-01184-5 · Cited by 19
Oral Anticoagulant Use and Appropriateness in Elderly Patients with Atrial Fibrillation in Complex Clinical Conditions: ACONVENIENCE Study
Bonanad, C., Formiga, F., Anguita, M. P., Torregrossa, R. P., & Gullón, A. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11247423 · Cited by 19
“Age has not been shown to increase the risk of major bleeds with DOACs, compared with VKAs, except in the case of high-dose dabigatran [53,54].”
Background
Novel Anticoagulants in Atrial Fibrillation: A Primer for the Primary Physician
Mookadam, M., Shamoun, F. E., & Mookadam, F. (2015) · The Journal of the American Board of Family Medicine · doi:10.3122/jabfm.2015.04.140297 · Cited by 19
Bleeding Risk, Management and Outcome in Patients Receiving Non-VKA Oral Anticoagulants (NOACs)
Werth, S., Breslin, T., NíAinle, F., & Beyer‐Westendorf, J. (2015) · American Journal of Cardiovascular Drugs · doi:10.1007/s40256-015-0123-6 · Cited by 19
Gastrointestinal disorders and dabigatran
Hoffman, A. W., & Galle, P. R. (2012) · Scandinavian Journal of Gastroenterology · doi:10.3109/00365521.2012.706825 · Cited by 19
“[42] Eikelboom JW,Wallentin L, Connolly SJ, EzekowitzM, et al.”
Real-Life Peak and Trough Dabigatran Plasma Measurements Over Time in Hospitalized Geriatric Patients with Atrial Fibrillation
Chaussade, E., Hanon, O., Boully, C., Labouree, F., Caillard, L. K., Gerotziafas, G., Vidal, J., & Elalamy, I. (2017) · The journal of nutrition health & aging · doi:10.1007/s12603-017-0982-4 · Cited by 19
Dabigatran Etexilate
McKeage, K. (2012) · PharmacoEconomics · doi:10.2165/11209130-000000000-00000 · Cited by 18
“In a subgroup analysis of the RE-LY trial, there was a significant treatment-by-age interaction for the primary safety endpoint, and both dabigatran dosages versus warfarin were associated with an increasing RR of major bleeding with increasing age.([22]) In patients aged <75 years, twice-daily dabigatran 110mg (1.”
BackgroundInfluential

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: Eikelboom, John W.
Wallentin, Lars
Connolly, Stuart J.
Healey, Jeff S.
Oldgren, Jonas
Alings, Marco
Kaatz, Scott
Hohnloser, Stefan H.
Diener, Hans-Christoph
Huber, Kurt
Yusuf, Salim
Venue: Circulation
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2011-05-31
Volume: 123
Issue: 21
Pages: 2363-2372
ISSN: 0009-7322 (ISSN-L)
1524-4539
DOI: 10.1161/circulationaha.110.004747
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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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

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