Dabigatran versus warfarin in patients with atrial fibrillation

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

doi:10.1056/NEJMoa0905561

Dabigatran versus warfarin in patients with atrial fibrillation

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

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

9460 Citationer (Scopus)

Abstract

Udgivelsesdato: 2009-Sep-17

Originalsprog	Engelsk
Tidsskrift	The New England Journal of Medicine
Vol/bind	361
Sider (fra-til)	1139-51
Antal sider	12
ISSN	0028-4793
DOI	https://doi.org/10.1056/NEJMoa0905561
Status	Udgivet - 2009
Udgivet eksternt	Ja

Bibliografisk note

2009 Massachusetts Medical Society

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10.1056/NEJMoa0905561

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Citationsformater

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., ... Rasmussen, L. H. (2009). Dabigatran versus warfarin in patients with atrial fibrillation. The New England Journal of Medicine, 361, 1139-51. https://doi.org/10.1056/NEJMoa0905561

@article{5a83d38aa497403283ed922c2291f5d9,

title = "Dabigatran versus warfarin in patients with atrial fibrillation",

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.)",

keywords = "Aged, Anticoagulants, Atrial Fibrillation, Benzimidazoles, Chi-Square Distribution, Double-Blind Method, Dyspepsia, Embolism, Female, Follow-Up Studies, Hemorrhage, Humans, Liver, Male, Middle Aged, Myocardial Infarction, Prodrugs, Proportional Hazards Models, Pyridines, Stroke, Warfarin",

author = "Connolly, {Stuart J} and Ezekowitz, {Michael D} and Salim Yusuf and John Eikelboom and Jonas Oldgren and Amit Parekh and Janice Pogue and Reilly, {Paul A} and Ellison Themeles and Jeanne Varrone and Susan Wang and Marco Alings and Denis Xavier and Jun Zhu and Rafael Diaz and Lewis, {Basil S} and Harald Darius and Hans-Christoph Diener and Joyner, {Campbell D} and Lars Wallentin and {RE-LY Steering Committee and Investigators} and Rasmussen, {Lars Hvilsted}",

note = "2009 Massachusetts Medical Society",

year = "2009",

doi = "10.1056/NEJMoa0905561",

language = "English",

volume = "361",

pages = "1139--51",

journal = "The New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

}

Connolly, SJ, Ezekowitz, MD, Yusuf, S, Eikelboom, J, Oldgren, J, Parekh, A, Pogue, J, Reilly, PA, Themeles, E, Varrone, J, Wang, S, Alings, M, Xavier, D, Zhu, J, Diaz, R, Lewis, BS, Darius, H, Diener, H-C, Joyner, CD, Wallentin, L, RE-LY Steering Committee and Investigators & Rasmussen, LH 2009, 'Dabigatran versus warfarin in patients with atrial fibrillation', The New England Journal of Medicine, bind 361, s. 1139-51. https://doi.org/10.1056/NEJMoa0905561

TY - JOUR

T1 - Dabigatran versus warfarin in patients with atrial fibrillation

AU - Connolly, Stuart J

AU - Ezekowitz, Michael D

AU - Yusuf, Salim

AU - Eikelboom, John

AU - Oldgren, Jonas

AU - Parekh, Amit

AU - Pogue, Janice

AU - Reilly, Paul A

AU - Themeles, Ellison

AU - Varrone, Jeanne

AU - Wang, Susan

AU - Alings, Marco

AU - Xavier, Denis

AU - Zhu, Jun

AU - Diaz, Rafael

AU - Lewis, Basil S

AU - Darius, Harald

AU - Diener, Hans-Christoph

AU - Joyner, Campbell D

AU - Wallentin, Lars

AU - RE-LY Steering Committee and Investigators

AU - Rasmussen, Lars Hvilsted

N1 - 2009 Massachusetts Medical Society

PY - 2009

Y1 - 2009

N2 - 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.)

AB - 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.)

KW - Aged

KW - Anticoagulants

KW - Atrial Fibrillation

KW - Benzimidazoles

KW - Chi-Square Distribution

KW - Double-Blind Method

KW - Dyspepsia

KW - Embolism

KW - Female

KW - Follow-Up Studies

KW - Hemorrhage

KW - Humans

KW - Liver

KW - Male

KW - Middle Aged

KW - Myocardial Infarction

KW - Prodrugs

KW - Proportional Hazards Models

KW - Pyridines

KW - Stroke

KW - Warfarin

U2 - 10.1056/NEJMoa0905561

DO - 10.1056/NEJMoa0905561

M3 - Journal article

SN - 0028-4793

VL - 361

SP - 1139

EP - 1151

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

ER -

Dabigatran versus warfarin in patients with atrial fibrillation

Abstract

Bibliografisk note

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AUB Link

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