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 WallentinA. M W Alings, J. V. Amerena, A. Avezum, I. Baumgartner, J. Brugada, A. Budaj, V. Caicedo, L. Ceremuzynski, J. H. Chen, P. J. Commerford, S. J. Connolly, A. L. Dans, H. Darius, G. Di Pasquale, R. Diaz, C. Erol, M. D. Ezekowitz, J. Ferreira, G. C. Flaker, M. D. Flather, M. G. Franzosi, R. Gamboa, S. P. Golitsyn, J. A. Gonzalez Hermosillo, D. Halon, H. Heidbuchel, S. H. Hohnloser, M. Hori, K. Huber, P. Jansky, G. Kamensky, M. Keltai, S. Kim, C. P. Lau, J. Y F Le Heuzey, B. S. Lewis, L. S. Liu, J. Nanas, J. Oldgren, P. S. Pais, A. N. Parkhomenko, K. E. Pedersen, L. S. Piegas, D. Raev, O. Razali, T. A. Simmers, P. J. Smith, M. Talajic, R. S. Tan, S. Tanomsup, L. Toivonen, D. Vinereanu, L. Wallentin, D. Xavier, S. Yusuf, J. Zhu

Research output: Contribution to journalArticle

7057 Citations (Scopus)

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

Original languageEnglish
Pages (from-to)1139-1151
Number of pages13
JournalNew England Journal of Medicine
Volume361
Issue number12
DOIs
Publication statusPublished - Sep 17 2009

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Warfarin
Atrial Fibrillation
Stroke
Antithrombins
Embolism
Confidence Intervals
Hemorrhage
Dabigatran

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Connolly, S. J., Ezekowitz, M. D., Yusuf, S., Eikelboom, J., Oldgren, J., Parekh, A., ... Zhu, J. (2009). Dabigatran versus warfarin in patients with atrial fibrillation. New England Journal of Medicine, 361(12), 1139-1151. https://doi.org/10.1056/NEJMoa0905561

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; Alings, A. M W; Amerena, J. V.; Avezum, A.; Baumgartner, I.; Brugada, J.; Budaj, A.; Caicedo, V.; Ceremuzynski, L.; Chen, J. H.; Commerford, P. J.; Connolly, S. J.; Dans, A. L.; Darius, H.; Di Pasquale, G.; Diaz, R.; Erol, C.; Ezekowitz, M. D.; Ferreira, J.; Flaker, G. C.; Flather, M. D.; Franzosi, M. G.; Gamboa, R.; Golitsyn, S. P.; Gonzalez Hermosillo, J. A.; Halon, D.; Heidbuchel, H.; Hohnloser, S. H.; Hori, M.; Huber, K.; Jansky, P.; Kamensky, G.; Keltai, M.; Kim, S.; Lau, C. P.; Le Heuzey, J. Y F; Lewis, B. S.; Liu, L. S.; Nanas, J.; Oldgren, J.; Pais, P. S.; Parkhomenko, A. N.; Pedersen, K. E.; Piegas, L. S.; Raev, D.; Razali, O.; Simmers, T. A.; Smith, P. J.; Talajic, M.; Tan, R. S.; Tanomsup, S.; Toivonen, L.; Vinereanu, D.; Wallentin, L.; Xavier, D.; Yusuf, S.; Zhu, J.

In: New England Journal of Medicine, Vol. 361, No. 12, 17.09.2009, p. 1139-1151.

Research output: Contribution to journalArticle

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, HC, Joyner, CD, Wallentin, L, Alings, AMW, Amerena, JV, Avezum, A, Baumgartner, I, Brugada, J, Budaj, A, Caicedo, V, Ceremuzynski, L, Chen, JH, Commerford, PJ, Connolly, SJ, Dans, AL, Darius, H, Di Pasquale, G, Diaz, R, Erol, C, Ezekowitz, MD, Ferreira, J, Flaker, GC, Flather, MD, Franzosi, MG, Gamboa, R, Golitsyn, SP, Gonzalez Hermosillo, JA, Halon, D, Heidbuchel, H, Hohnloser, SH, Hori, M, Huber, K, Jansky, P, Kamensky, G, Keltai, M, Kim, S, Lau, CP, Le Heuzey, JYF, Lewis, BS, Liu, LS, Nanas, J, Oldgren, J, Pais, PS, Parkhomenko, AN, Pedersen, KE, Piegas, LS, Raev, D, Razali, O, Simmers, TA, Smith, PJ, Talajic, M, Tan, RS, Tanomsup, S, Toivonen, L, Vinereanu, D, Wallentin, L, Xavier, D, Yusuf, S & Zhu, J 2009, 'Dabigatran versus warfarin in patients with atrial fibrillation', New England Journal of Medicine, vol. 361, no. 12, pp. 1139-1151. https://doi.org/10.1056/NEJMoa0905561
Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A et al. Dabigatran versus warfarin in patients with atrial fibrillation. New England Journal of Medicine. 2009 Sep 17;361(12):1139-1151. https://doi.org/10.1056/NEJMoa0905561
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 ; Alings, A. M W ; Amerena, J. V. ; Avezum, A. ; Baumgartner, I. ; Brugada, J. ; Budaj, A. ; Caicedo, V. ; Ceremuzynski, L. ; Chen, J. H. ; Commerford, P. J. ; Connolly, S. J. ; Dans, A. L. ; Darius, H. ; Di Pasquale, G. ; Diaz, R. ; Erol, C. ; Ezekowitz, M. D. ; Ferreira, J. ; Flaker, G. C. ; Flather, M. D. ; Franzosi, M. G. ; Gamboa, R. ; Golitsyn, S. P. ; Gonzalez Hermosillo, J. A. ; Halon, D. ; Heidbuchel, H. ; Hohnloser, S. H. ; Hori, M. ; Huber, K. ; Jansky, P. ; Kamensky, G. ; Keltai, M. ; Kim, S. ; Lau, C. P. ; Le Heuzey, J. Y F ; Lewis, B. S. ; Liu, L. S. ; Nanas, J. ; Oldgren, J. ; Pais, P. S. ; Parkhomenko, A. N. ; Pedersen, K. E. ; Piegas, L. S. ; Raev, D. ; Razali, O. ; Simmers, T. A. ; Smith, P. J. ; Talajic, M. ; Tan, R. S. ; Tanomsup, S. ; Toivonen, L. ; Vinereanu, D. ; Wallentin, L. ; Xavier, D. ; Yusuf, S. ; Zhu, J. / Dabigatran versus warfarin in patients with atrial fibrillation. In: New England Journal of Medicine. 2009 ; Vol. 361, No. 12. pp. 1139-1151.
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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",
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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 - Alings, A. M W

AU - Amerena, J. V.

AU - Avezum, A.

AU - Baumgartner, I.

AU - Brugada, J.

AU - Budaj, A.

AU - Caicedo, V.

AU - Ceremuzynski, L.

AU - Chen, J. H.

AU - Commerford, P. J.

AU - Connolly, S. J.

AU - Dans, A. L.

AU - Darius, H.

AU - Di Pasquale, G.

AU - Diaz, R.

AU - Erol, C.

AU - Ezekowitz, M. D.

AU - Ferreira, J.

AU - Flaker, G. C.

AU - Flather, M. D.

AU - Franzosi, M. G.

AU - Gamboa, R.

AU - Golitsyn, S. P.

AU - Gonzalez Hermosillo, J. A.

AU - Halon, D.

AU - Heidbuchel, H.

AU - Hohnloser, S. H.

AU - Hori, M.

AU - Huber, K.

AU - Jansky, P.

AU - Kamensky, G.

AU - Keltai, M.

AU - Kim, S.

AU - Lau, C. P.

AU - Le Heuzey, J. Y F

AU - Lewis, B. S.

AU - Liu, L. S.

AU - Nanas, J.

AU - Oldgren, J.

AU - Pais, P. S.

AU - Parkhomenko, A. N.

AU - Pedersen, K. E.

AU - Piegas, L. S.

AU - Raev, D.

AU - Razali, O.

AU - Simmers, T. A.

AU - Smith, P. J.

AU - Talajic, M.

AU - Tan, R. S.

AU - Tanomsup, S.

AU - Toivonen, L.

AU - Vinereanu, D.

AU - Wallentin, L.

AU - Xavier, D.

AU - Yusuf, S.

AU - Zhu, J.

PY - 2009/9/17

Y1 - 2009/9/17

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

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

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U2 - 10.1056/NEJMoa0905561

DO - 10.1056/NEJMoa0905561

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JO - New England Journal of Medicine

JF - New England Journal of Medicine

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