Dabigatran versus warfarin in patients with atrial fibrillation

Connolly, Stuart J.; Ezekowitz, Michael D.; Yusuf, Salim; Eikelboom, John; Oldgren, Jonas; Parekh, Amit; Pogue, Janice; Reilly, Paul A.; Themeles, Ellison; Varrone, Jeanne; Wang, Susan; Alings, Marco; Xavier, Denis; Zhu, Jun; Diaz, Rafael; Lewis, Basil S.; Darius, Harald; Diener, Hans-Christoph; Joyner, Campbell D.; Wallentin, Lars

doi:10.1056/nejmoa0905561

Cited by 11,215Atrial Fibrillation Management and OutcomesVenous Thromboembolism Diagnosis and ManagementAcute Ischemic Stroke Management

Dabigatran versus warfarin in patients with atrial fibrillation

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Connolly, Stuart J., Ezekowitz, Michael D., Yusuf, Salim, Eikelboom, John, Oldgren, Jonas, Parekh, Amit, Pogue, Janice, Reilly, Paul A. +12 more·2009·New England Journal of Medicine

DOI 10.1056/nejmoa0905561

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Abstract

BACKGROUND: Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. METHODS: In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. RESULTS: Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051). CONCLUSIONS: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.)

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Dabigatran 110 mg twice daily was non-inferior to warfarin for prevention of stroke and systemic embolism, with 20% fewer major bleeding events.
“Dabigatran 110 mg twice daily was non-inferior to warfarin for prevention of stroke and systemic embolism, with 20% fewer major bleeding events.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [318]
In the RE-LY study, dabigatran 150 mg twice daily reduced stroke and systemic embolism by 35% compared with warfarin without a significant difference in major bleeding events.
“In the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) study, 318,404 dabigatran 150 mg twice daily reduced stroke and systemic embolism by 35% compared with warfarin without a significant difference in major bleeding events.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [318]
Both dabigatran doses significantly reduced haemorrhagic stroke and intracranial haemorrhage.
“Both dabigatran doses significantly reduced haemorrhagic stroke and intracranial haemorrhage.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [318]
There was a non-significant numerical increase in the rate of myocardial infarction with both dabigatran doses, which has not been replicated in large post-authorization analyses.
“There was a non-significant numerical increase in the rate of myocardial infarction with both dabigatran doses, 318,404 which has not been replicated in large post-authorization analyses.396”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [318]
There are no randomized trials assessing oral anticoagulation in haemodialysis patients, and no controlled trials of NOACs in patients with severe CKD (CrCl < 25-30 mL/min).
“There are no randomized trials assessing OAC in haemodialysis patients, 418 and no controlled trials of NOACs in patients with severe CKD (CrCl < 25-30 mL/min).”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [318]

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ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012
Authors/Task Force Members, McMurray, J. J. V., Adamopoulos, S., Anker, S. D., Auricchio, A., Böhm, M., Dickstein, K., Falk, V., Filippatos, G., Fonseca, C., et al. (2012) · European Journal of Heart Failure · doi:10.1093/eurjhf/hfs105 · Cited by 2,644 · see citing works
Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism
Schulman, S., Kearon, C., Kakkar, A. K., Mismetti, P., Schellong, S., Eriksson, H., Baanstra, D., Schnee, J. M., & Goldhaber, S. Z. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0906598 · Cited by 2,572 · see citing works
2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines
Nishimura, R. A., Otto, C. M., Bonow, R. O., Carabello, B. A., Erwin, J. P., Fleisher, L. A., Jneid, H. M., Mack, M. J., McLeod, C. J., O’Gara, P. T., et al. (2017) · Circulation · doi:10.1161/cir.0000000000000503 · Cited by 2,506 · see citing works
2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
Otto, C. M., Nishimura, R. A., Bonow, R. O., Carabello, B. A., Erwin, J. P., Gentile, F., Jneid, H., Krieger, E. V., Mack, M., McLeod, C., et al. (2021) · Circulation · doi:10.1161/cir.0000000000000932 · Cited by 2,449 · see citing works
Apixaban in patients with atrial fibrillation
Connolly, S. J., Eikelboom, J., Joyner, C., Diener, H.-C., Hart, R., Golitsyn, S., Flaker, G., Avezum, A., Hohnloser, S. H., Diaz, R., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1007432 · Cited by 2,483 · see citing works
2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
Heidenreich, P. A., Bozkurt, B., Aguilar, D., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., et al. (2022) · Circulation · doi:10.1161/cir.0000000000001063 · Cited by 4,922 · see citing works
2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation
January, C. T., Wann, L. S., Calkins, H. G., Chen, L. Y., Cigarroa, J. E., Cleveland, J. C., Ellinor, P. T., Ezekowitz, M. D., Field, M. E., Furie, K. L., et al. (2019) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.01.011 · Cited by 2,237 · see citing works
2013 ACCF/AHA Guideline for the Management of Heart Failure
Yancy, C. W., Jessup, M. L., Bozkurt, B., Butler, J., Casey, D. E., Drazner, M. H., Fonarow, G. C., Geraci, S. A., Horwich, T. B., Januzzi, J. L., et al. (2013) · Circulation · doi:10.1161/cir.0b013e31829e8776 · Cited by 2,129 · see citing works
2011 ACCF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy
Gersh, B. J., Maron, B. J., Bonow, R. O., Dearani, J. A., Fifer, M. A., Link, M. S., Naidu, S. S., Nishimura, R. A., Ommen, S. R., Rakowski, H., et al. (2011) · Circulation · doi:10.1161/cir.0b013e318223e2bd · Cited by 2,105 · see citing works
2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society
January, C. T., Wann, L. S., Alpert, J. S., Calkins, H., Cigarroa, J. E., Cleveland, J. C., Conti, J. B., Ellinor, P. T., Ezekowitz, M. D., Field, M. E., et al. (2014) · Circulation · doi:10.1161/cir.0000000000000040 · Cited by 2,056 · see citing works
2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease
Otto, C. M., Nishimura, R. A., Bonow, R. O., Carabello, B. A., Erwin, J. P., Gentile, F., Jneid, H. M., Krieger, E. V., Mack, M. J., McLeod, C., et al. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.11.018 · Cited by 2,073 · see citing works
Stroke risk factors, genetics, and prevention
Boehme, A. K., Esenwa, C., & Elkind, M. S. V. (2017) · Circulation Research · doi:10.1161/circresaha.116.308398 · Cited by 1,952 · see citing works
ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD
Authors Task Force Members, Rydén, L., Grant, P. J., Anker, S. D., Berne, C., Cosentino, F., Danchin, N., Deaton, C., Escaned, J., Hammes, H., et al. (2013) · European Heart Journal · doi:10.1093/eurheartj/eht108 · Cited by 1,958 · see citing works
Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy
Holmes, D. R., Kar, S., Price, M. J., Whisenant, B. K., Sievert, H., Doshi, S. K., Huber, K., & Reddy, V. Y. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.04.029 · Cited by 1,850 · see citing works
Guidelines for the management of atrial fibrillation
Authors/Task Force Members, Camm, A. J., Kirchhof, P. F., Lip, G. Y. H., Schotten, U., Savelieva, I., Ernst, S., Gelder, I. C. V., Al‐Attar, N., Hindricks, G., et al. (2010) · EP Europace · doi:10.1093/europace/euq350 · Cited by 1,749 · see citing works
Embolic strokes of undetermined source: the case for a new clinical construct
Hart, R. G., Diener, H., Coutts, S. B., Easton, J. D., Granger, C. B., O'Donnell, M. J., Sacco, R. L., & Connolly, S. J. (2014) · The Lancet Neurology · doi:10.1016/s1474-4422(13)70310-7 · Cited by 1,687 · see citing works
2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design
Calkins, H., Kuck, K., Cappato, R., Brugada, J., Camm, A., Chen, S.-A., Crijns, H., Damiano, R., Davies, D., Dimarco, J., et al. (2012) · Journal of interventional cardiac electrophysiology · doi:10.1007/s10840-012-9672-7 · Cited by 1,959 · see citing works
The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation
Steffel, J., Verhamme, P., Potpara, T. S., Albaladejo, P., Antz, M., Desteghe, L., Haeusler, K. G., Oldgren, J., Reinecke, H., Roldan-Schilling, V., et al. (2018) · European Heart Journal · doi:10.1093/eurheartj/ehy136 · Cited by 2,123 · see citing works
“Based on these new developments, a novel classification has recently been suggested where a functional EHRA (Evaluated Heartvalves, Rheumatic or Artificial) categorization is proposed, depending on the type of OAC use in patients with AF.6 In this scheme, EHRA Type 1 refers to AF patients with VHD needing therapy with…”
BackgroundMethodResultInfluential
Dabigatran versus warfarin in patients with mechanical heart valves
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., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1300615 · Cited by 1,506 · see citing works
Oral Anticoagulant Therapy
Ageno, W., Gallus, A. S., Wittkowsky, A. K., Crowther, M. A., Hylek, E. M., & Palareti, G. (2012) · CHEST Journal · doi:10.1378/chest.11-2292 · Cited by 1,505 · see citing works
Guidelines for the Management of Spontaneous Intracerebral Hemorrhage
Morgenstern, L. B., Hemphill, J. C., Anderson, C. S., Becker, K. J., Broderick, J. P., Connolly, E. S., Greenberg, S. M., Huang, J. N., Macdonald, R. L., Messe, S. R., et al. (2010) · Stroke · doi:10.1161/str.0b013e3181ec611b · Cited by 1,486 · see citing works
Guidelines for the Prevention of Stroke in Patients With Stroke or Transient Ischemic Attack
Furie, K. L., Kasner, S. E., Adams, R. J., Albers, G. W., Bush, R. L., Fagan, S. C., Halperin, J. L., Johnston, S. C., Katzan, I. L., Kernan, W. N., et al. (2010) · Stroke · doi:10.1161/str.0b013e3181f7d043 · Cited by 1,492 · see citing works
2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: Recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design
Calkins, H., Kuck, K. H., Cappato, R., Brugada, J., Camm, A. J., Chen, S.-A., Crijns, H. J. G., Damiano, R. J., Davies, D. W., DiMarco, J., et al. (2012) · Heart Rhythm · doi:10.1016/j.hrthm.2011.12.016 · Cited by 1,456 · see citing works
Self-citation
Definition of clinically relevant non‐major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non‐surgical patients: communication from the SSC of the ISTH
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2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
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Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation
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The Coagulopathy of Chronic Liver Disease
Tripodi, A., & Mannucci, P. M. (2011) · New England Journal of Medicine · doi:10.1056/nejmra1011170 · Cited by 1,384 · see citing works
Dabigatran etexilate – a novel, reversible, oral direct thrombin inhibitor: Interpretation of coagulation assays and reversal of anticoagulant activity
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Reversal of Rivaroxaban and Dabigatran by Prothrombin Complex Concentrate
Eerenberg, E. S., Kamphuisen, P. W., Sijpkens, M. K., Meijers, J. C. M., Buller, H. R., & Levi, M. M. (2011) · Circulation · doi:10.1161/circulationaha.111.029017 · Cited by 1,353 · see citing works
2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline)
Wann, L. S., Curtis, A. B., January, C. T., Ellenbogen, K. A., Lowe, J. E., Estes, N. A. M., Page, R. L., Ezekowitz, M. D., Slotwiner, D. J., Jackman, W. M., et al. (2010) · Circulation · doi:10.1161/cir.0b013e3181fa3cf4 · Cited by 1,338 · see citing works
Guidelines for the Primary Prevention of Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association
Goldstein, L. B., Bushnell, C. D., Adams, R. J., Appel, L. J., Braun, L. T., Chaturvedi, S., Creager, M. A., Culebras, A., Eckel, R. H., Hart, R. G., et al. (2011) · Stroke · doi:10.1161/str.0b013e3181fcb238 · Cited by 1,306 · see citing works
2011 ACCF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy
Gersh, B. J., Maron, B. J., Bonow, R. O., Dearani, J. A., Fifer, M. A., Link, M. S., Naidu, S. S., Nishimura, R. A., Ommen, S. R., Rakowski, H., et al. (2011) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2011.06.011 · Cited by 1,276 · see citing works
Pathophysiological mechanisms of atrial fibrillation: a translational appraisal
Schotten, U., Verheule, S., Kirchhof, P., & Goette, A. (2011) · Physiological Reviews · doi:10.1152/physrev.00031.2009 · Cited by 1,273 · see citing works
Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation
Lopes, R. D., Heizer, G., Aronson, R., Vora, A. N., Massaro, T., Mehran, R., Goodman, S. G., Windecker, S., Darius, H., Li, J., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1817083 · Cited by 1,228 · see citing works
Self-citation
Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study
Friberg, L., Rosenqvist, M., & Lip, G. Y. H. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehr488 · Cited by 1,192 · see citing works
Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation
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2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation
Calkins, H. G., Hindricks, G., Cappato, R., Kim, Y., Saad, E., Aguinaga, L., Akar, J. G., Badhwar, V., Brugada, J., Camm, A. J., et al. (2017) · EP Europace · doi:10.1093/europace/eux274 · Cited by 1,191 · see citing works
Idarucizumab for Dabigatran Reversal — Full Cohort Analysis
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2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation
Steffel, J., Collins, R., Antz, M., Cornu, P., Desteghe, L., Haeusler, K. G., Oldgren, J., Reinecke, H., Roldan-Schilling, V., Rowell, N., et al. (2021) · EP Europace · doi:10.1093/europace/euab065 · Cited by 1,132 · see citing works
Self-citation
Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation
Heidbüchel, H., Verhamme, P. B., Alings, M., Antz, M., Diener, H., Hacke, W., Oldgren, J., Sinnaeve, P., Camm, A. J., & Kirchhof, P. F. (2015) · EP Europace · doi:10.1093/europace/euv309 · Cited by 1,114 · see citing works
2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary
Otto, C. M., Nishimura, R. A., Bonow, R. O., Carabello, B. A., Erwin, J. P., Gentile, F., Jneid, H. M., Krieger, E. V., Mack, M. J., McLeod, C., et al. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.11.035 · Cited by 1,104 · see citing works
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
Eikelboom, J. W., Wallentin, L., Connolly, S. J., Ezekowitz, M., Healey, J. S., Oldgren, J., Yang, S., Alings, M., Kaatz, S., Hohnloser, S. H., et al. (2011) · Circulation · doi:10.1161/circulationaha.110.004747 · Cited by 1,081 · see citing works
Comparative Validation of a Novel Risk Score for Predicting Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation
Lip, G. Y. H., Frison, L., Halperin, J. L., & Lane, D. A. (2010) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2010.09.024 · Cited by 1,077 · see citing works
5-Year Outcomes After Left Atrial Appendage Closure
Reddy, V. Y., Doshi, S. K., Kar, S., Gibson, D. N., Price, M. J., Huber, K., Horton, R., Buchbinder, M., Neužil, P., Gordon, N. T., et al. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.10.021 · Cited by 1,039 · see citing works
Percutaneous Left Atrial Appendage Closure vs Warfarin for Atrial Fibrillation: A Randomized Clinical Trial
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Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial
Wallentin, L. C., Yusuf, S., Ezekowitz, M. D., Alings, M., Flather, M. D., Franzosi, M. G., Pais, P. S., Dans, A., Eikelboom, J. W., Oldgren, J., et al. (2010) · The Lancet · doi:10.1016/s0140-6736(10)61194-4 · Cited by 1,011 · see citing works
Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism
Schulman, S., Kearon, C., Kakkar, A. K., Schellong, S., Eriksson, H., Baanstra, D., Kvamme, A. M., Friedman, J., Mismetti, P., & Goldhaber, S. Z. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1113697 · Cited by 983 · see citing works
Guidelines for the Prevention of Stroke in Women: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association
Bushnell, C., McCullough, L. D., Awad, I. A., Chireau, M. V., Fedder, W. N., Furie, K. L., Howard, V. J., Lichtman, J. H., Lisabeth, L. D., Piña, I. L., et al. (2014) · Stroke · doi:10.1161/01.str.0000442009.06663.48 · Cited by 941 · see citing works
Antithrombotic Therapy for Atrial Fibrillation
Lip, G. Y. H., Banerjee, A., Boriani, G., Chiang, C. E., Fargo, R. A., Freedman, B., Lane, D. A., Ruff, C. T., Turakhia, M. P., Werring, D. J., et al. (2018) · CHEST Journal · doi:10.1016/j.chest.2018.07.040 · Cited by 952 · see citing works
2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
Heidenreich, P. A., Bozkurt, B., Aguilar, D. A., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., et al. (2022) · Circulation · doi:10.1161/cir.0000000000001062 · Cited by 956 · see citing works
Treatment of Acute Venous Thromboembolism With Dabigatran or Warfarin and Pooled Analysis
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Stroke and bleeding in atrial fibrillation with chronic kidney disease
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Antithrombotic Therapy for Atrial Fibrillation
You, J. J., Singer, D. E., Howard, P. A., Lane, D. A., Eckman, M. H., Fang, M. C., Hylek, E. M., Schulman, S., Go, A. S., Hughes, M., et al. (2012) · CHEST Journal · doi:10.1378/chest.11-2304 · Cited by 924 · see citing works
Cardiovascular disease in chronic kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO)
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2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation
Joglar, J. A., Chung, M. K., Armbruster, A. L., Benjamin, E. J., Chyou, J. Y., Cronin, E. M., Deswal, A., Eckhardt, L. L., Goldberger, Z. D., Gopinathannair, R., et al. (2024) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2023.08.017 · Cited by 933 · see citing works
Management of severe perioperative bleeding
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2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary
Heidenreich, P. A., Bozkurt, B., Aguilar, D., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., et al. (2022) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2021.12.011 · Cited by 931 · see citing works
Antiphospholipid syndrome
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A New Risk Scheme to Predict Warfarin-Associated Hemorrhage
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Does the Left Atrial Appendage Morphology Correlate With the Risk of Stroke in Patients With Atrial Fibrillation?
Biase, L. D., Santangeli, P., Anselmino, M., Mohanty, P. K., Salvetti, I., Gili, S., Horton, R., Sánchez, J., Bai, R., Mohanty, S., et al. (2012) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2012.04.032 · Cited by 855 · see citing works
Ischemic Stroke
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The Effect of Dabigatran Plasma Concentrations and Patient Characteristics on the Frequency of Ischemic Stroke and Major Bleeding in Atrial Fibrillation Patients
Reilly, P. A., Lehr, T., Haertter, S., Connolly, S. J., Yusuf, S., Eikelboom, J. W., Ezekowitz, M. D., Nehmiz, G., Wang, S., & Wallentin, L. C. (2013) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2013.07.104 · Cited by 834 · see citing works
GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines
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Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source
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Serological correlation with cardiovascular manifestations of systemic lupus erythematosus patients in India
Ahmed, I., Datta, A. K., de, A. W., Roy, P., Soren, M., & Guha, S. (2015) · Indian Heart Journal · doi:10.1016/j.ihj.2015.10.316
Dabigatran versus Warfarin in Patients with Atrial Fibrillation: A Randomized Controlled Trial
Malik, D. M., Kumar, D. A., Manohar, M., & Singh, A. (2024) · International Journal of Pharmaceutical Sciences Review and Research · doi:10.47583/ijpsrr.2024.v84i07.038
Comparison of dabigatran and warfarin used in patients with non-valvular atrial fibrillation
Yu, Y., Liu, J., Fu, G., Fang, R., Gao, F., & Chu, H. (2018) · Medicine · doi:10.1097/md.0000000000012841 · Cited by 12 · see citing works
Is Dabigatran Non-inferior to Warfarin for the Prevention of Stroke in Those with Atrial Fibrillation?
Burlakoff, B. (2012) · Digital Commons - PCOM (Philadelphia College of Osteopathic Medicine)
Dabigatran and atrial fibrillation: the alternative to warfarin for selected patients.
(2012) · PubMed · Cited by 3 · see citing works

Authors: Connolly, S. J., Ezekowitz, M. D., Yusuf, S., Eikelboom, J., Oldgren, J., Parekh, A., Pogue, J., Reilly, P. A., Themeles, E., Varrone, J., Wang, S., Alings, M., Xavier, D., Zhu, J., Diaz, R., Lewis, B. S., Darius, H., Diener, H.-C., Joyner, C. D., & Wallentin, L.
Affiliations: Population Health Research Institute (CA)
Lankenau Institute for Medical Research (US)
Uppsala University (SE)
Boehringer Ingelheim (United States) (US)
Werkgroep Cardiologische centra Nederland (NL)
St. John's National Academy of Health Sciences (IN)
Fu Wai Hospital (CN)
Carmel Medical Center (IL)
Vivantes Klinikum (DE)
Sunnybrook Health Science Centre (CA)
ORCID: Connolly, Stuart J.
Ezekowitz, Michael D.
Yusuf, Salim
Eikelboom, John
Oldgren, Jonas
Parekh, Amit
Alings, Marco
Xavier, Denis
Zhu, Jun
Lewis, Basil S.
Wallentin, Lars
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2009-09-17
Volume: 361
Issue: 12
Pages: 1139-1151
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa0905561
OpenAlex: W2136489990
Cited by: 11,215
References: 18
Citations by year: 2026: 219 · 2025: 318 · 2024: 395 · 2023: 489 · 2022: 507 · 2021: 662 · 2020: 745 · 2019: 669 · 2018: 775 · 2017: 799 · 2016: 864 · 2015: 923 · 2014: 874 · 2013: 1000 · 2012: 915
FWCI: 419.63
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
UWA Profiles and Research Repository (UWA) (publishedVersion, other-oa)
PubMed (publishedVersion)
Pure Amsterdam UMC (publishedVersion)
Minerva Access (University of Melbourne) (submittedVersion)
Data Archiving and Networked Services (DANS) (submittedVersion)
ArTS Archivio della ricerca di Trieste (University of Trieste https://www.units.it/) (submittedVersion)
Figshare (submittedVersion)
UnissResearch (Università degli Studi di Sassari) (submittedVersion)
Open Repository and Bibliography (University of Liège) (submittedVersion)
Funders: Bristol-Myers Squibb
Eli Lilly and Company
Pfizer
AstraZeneca
GlaxoSmithKline
Sanofi
Daiichi-Sankyo
Eisai
Servier
Cilag
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 › Epidemiology › Acute Ischemic Stroke Management
Keywords: dabigatran, warfarin, atrial fibrillation, direct thrombin inhibitors, oral anticoagulants, stroke prevention, systemic embolism, major bleeding, hemorrhagic stroke, non-inferiority, mortality, fixed-dose dosing, bleeding risk stratification, anticoagulation
MeSH terms: Dabigatran, Aged, Anticoagulants, Atrial Fibrillation, Benzimidazoles, Double-Blind Method, Dyspepsia, Embolism, Female, Follow-Up Studies, Hemorrhage, Humans, Liver, Male, Middle Aged, Myocardial Infarction, Prodrugs, Pyridines, Warfarin, Chi-Square Distribution, Proportional Hazards Models, Stroke

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