Apixaban versus warfarin in patients with atrial fibrillation

Christopher Granger; John Alexander; John McMurray; Renato Lopes; Elaine Hylek; Michael Hanna; Hussein Al-Khalidi; Jack Ansell; Dan Atar; Alvaro Avezum; M Bahit; Rafael Diaz; Donald Easton; Justin Ezekowitz; Greg Flaker; David Garcia; Margarida Geraldes; Bernard Gersh; Sergey Golitsyn; Shinya Goto; Antonio Hermosillo; Stefan Hohnloser; John Horowitz; Puneet Mohan; Petr Jansky; Basil Lewis; Jose Lopez-Sendon; Prem Pais; Alexander Parkhomenko; Freek Verheugt; Jun Zhu; Lars Wallentin; M Vico; I Mackinnon; D Vogel; A. Gabito; A Cassettari; C Zaidman; O Montana; A. Hrabar; H Jure; H Lastiri; C. Poy; A Caccavo; C Cuneo; H Colombo; F Rolandi; A Hershson; M Garrido; A Sanchez; M L Bruno; D Piskorz; J Cuadrado; E Hasbani; J Serra; L Cartasegna; P Schygiel; C Muratore; J Marino; M I Sosa Liprandi; R. A. Guerrero; H Ramos; D Mercado; L Guzmon; C Beneitez; J Estepo; R. Torrijos; E Retyk; N Vita; H Luciardi; M Casey; S Orlando; M B Labarta; D Santos; J Amerena; P Purnell; J Horowitz; H Salem; A Lui; L Zimmet; S Roger; Fred De Looze; R Lehman; B Jackson; D Ashby; W Heddle

doi:10.1056/NEJMoa1107039

Apixaban versus warfarin in patients with atrial fibrillation

Christopher Granger, John Alexander, John McMurray, Renato Lopes, Elaine Hylek, Michael Hanna, Hussein Al-Khalidi, Jack Ansell, Dan Atar, Alvaro Avezum, M Bahit, Rafael Diaz, Donald Easton, Justin Ezekowitz, Greg Flaker, David Garcia, Margarida Geraldes, Bernard Gersh, Sergey Golitsyn, Shinya GotoAntonio Hermosillo, Stefan Hohnloser, John Horowitz, Puneet Mohan, Petr Jansky, Basil Lewis, Jose Lopez-Sendon, Prem Pais, Alexander Parkhomenko, Freek Verheugt, Jun Zhu, Lars Wallentin, M Vico, I Mackinnon, D Vogel, A. Gabito, A Cassettari, C Zaidman, O Montana, A. Hrabar, H Jure, H Lastiri, C. Poy, A Caccavo, C Cuneo, H Colombo, F Rolandi, A Hershson, M Garrido, A Sanchez, M L Bruno, D Piskorz, J Cuadrado, E Hasbani, J Serra, L Cartasegna, P Schygiel, C Muratore, J Marino, M I Sosa Liprandi, R. A. Guerrero, H Ramos, D Mercado, L Guzmon, C Beneitez, J Estepo, R. Torrijos, E Retyk, N Vita, H Luciardi, M Casey, S Orlando, M B Labarta, D Santos, J Amerena, P Purnell, J Horowitz, H Salem, A Lui, L Zimmet, S Roger, Fred De Looze, R Lehman, B Jackson, D Ashby, W Heddle

College of Medicine and Public Health

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Abstract

BACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. METHODS: In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. RESULTS: The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P = 0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P = 0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P = 0.42). CONCLUSIONS: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.

Original language	English
Pages (from-to)	981-992
Number of pages	12
Journal	New England Journal of Medicine
Volume	365
Issue number	11
DOIs	https://doi.org/10.1056/NEJMoa1107039
Publication status	Published - 15 Sept 2011

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10.1056/NEJMoa1107039

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Granger, C., Alexander, J., McMurray, J., Lopes, R., Hylek, E., Hanna, M., Al-Khalidi, H., Ansell, J., Atar, D., Avezum, A., Bahit, M., Diaz, R., Easton, D., Ezekowitz, J., Flaker, G., Garcia, D., Geraldes, M., Gersh, B., Golitsyn, S., ... Heddle, W. (2011). Apixaban versus warfarin in patients with atrial fibrillation. New England Journal of Medicine, 365(11), 981-992. https://doi.org/10.1056/NEJMoa1107039

@article{1bfba67a340240fd814bde63187856ca,

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

abstract = "BACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. METHODS: In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. RESULTS: The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P = 0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P = 0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P = 0.42). CONCLUSIONS: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.",

author = "Christopher Granger and John Alexander and John McMurray and Renato Lopes and Elaine Hylek and Michael Hanna and Hussein Al-Khalidi and Jack Ansell and Dan Atar and Alvaro Avezum and M Bahit and Rafael Diaz and Donald Easton and Justin Ezekowitz and Greg Flaker and David Garcia and Margarida Geraldes and Bernard Gersh and Sergey Golitsyn and Shinya Goto and Antonio Hermosillo and Stefan Hohnloser and John Horowitz and Puneet Mohan and Petr Jansky and Basil Lewis and Jose Lopez-Sendon and Prem Pais and Alexander Parkhomenko and Freek Verheugt and Jun Zhu and Lars Wallentin and M Vico and I Mackinnon and D Vogel and A. Gabito and A Cassettari and C Zaidman and O Montana and A. Hrabar and H Jure and H Lastiri and C. Poy and A Caccavo and C Cuneo and H Colombo and F Rolandi and A Hershson and M Garrido and A Sanchez and Bruno, {M L} and D Piskorz and J Cuadrado and E Hasbani and J Serra and L Cartasegna and P Schygiel and C Muratore and J Marino and {Sosa Liprandi}, {M I} and Guerrero, {R. A.} and H Ramos and D Mercado and L Guzmon and C Beneitez and J Estepo and R. Torrijos and E Retyk and N Vita and H Luciardi and M Casey and S Orlando and Labarta, {M B} and D Santos and J Amerena and P Purnell and J Horowitz and H Salem and A Lui and L Zimmet and S Roger and {De Looze}, Fred and R Lehman and B Jackson and D Ashby and W Heddle",

year = "2011",

month = sep,

day = "15",

doi = "10.1056/NEJMoa1107039",

language = "English",

volume = "365",

pages = "981--992",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "11",

}

Granger, C, Alexander, J, McMurray, J, Lopes, R, Hylek, E, Hanna, M, Al-Khalidi, H, Ansell, J, Atar, D, Avezum, A, Bahit, M, Diaz, R, Easton, D, Ezekowitz, J, Flaker, G, Garcia, D, Geraldes, M, Gersh, B, Golitsyn, S, Goto, S, Hermosillo, A, Hohnloser, S, Horowitz, J, Mohan, P, Jansky, P, Lewis, B, Lopez-Sendon, J, Pais, P, Parkhomenko, A, Verheugt, F, Zhu, J, Wallentin, L, Vico, M, Mackinnon, I, Vogel, D, Gabito, A, Cassettari, A, Zaidman, C, Montana, O, Hrabar, A, Jure, H, Lastiri, H, Poy, C, Caccavo, A, Cuneo, C, Colombo, H, Rolandi, F, Hershson, A, Garrido, M, Sanchez, A, Bruno, ML, Piskorz, D, Cuadrado, J, Hasbani, E, Serra, J, Cartasegna, L, Schygiel, P, Muratore, C, Marino, J, Sosa Liprandi, MI, Guerrero, RA, Ramos, H, Mercado, D, Guzmon, L, Beneitez, C, Estepo, J, Torrijos, R, Retyk, E, Vita, N, Luciardi, H, Casey, M, Orlando, S, Labarta, MB, Santos, D, Amerena, J, Purnell, P, Horowitz, J, Salem, H, Lui, A, Zimmet, L, Roger, S, De Looze, F, Lehman, R, Jackson, B, Ashby, D & Heddle, W 2011, 'Apixaban versus warfarin in patients with atrial fibrillation', New England Journal of Medicine, vol. 365, no. 11, pp. 981-992. https://doi.org/10.1056/NEJMoa1107039

TY - JOUR

T1 - Apixaban versus warfarin in patients with atrial fibrillation

AU - Granger, Christopher

AU - Alexander, John

AU - McMurray, John

AU - Lopes, Renato

AU - Hylek, Elaine

AU - Hanna, Michael

AU - Al-Khalidi, Hussein

AU - Ansell, Jack

AU - Atar, Dan

AU - Avezum, Alvaro

AU - Bahit, M

AU - Diaz, Rafael

AU - Easton, Donald

AU - Ezekowitz, Justin

AU - Flaker, Greg

AU - Garcia, David

AU - Geraldes, Margarida

AU - Gersh, Bernard

AU - Golitsyn, Sergey

AU - Goto, Shinya

AU - Hermosillo, Antonio

AU - Hohnloser, Stefan

AU - Horowitz, John

AU - Mohan, Puneet

AU - Jansky, Petr

AU - Lewis, Basil

AU - Lopez-Sendon, Jose

AU - Pais, Prem

AU - Parkhomenko, Alexander

AU - Verheugt, Freek

AU - Zhu, Jun

AU - Wallentin, Lars

AU - Vico, M

AU - Mackinnon, I

AU - Vogel, D

AU - Gabito, A.

AU - Cassettari, A

AU - Zaidman, C

AU - Montana, O

AU - Hrabar, A.

AU - Jure, H

AU - Lastiri, H

AU - Poy, C.

AU - Caccavo, A

AU - Cuneo, C

AU - Colombo, H

AU - Rolandi, F

AU - Hershson, A

AU - Garrido, M

AU - Sanchez, A

AU - Bruno, M L

AU - Piskorz, D

AU - Cuadrado, J

AU - Hasbani, E

AU - Serra, J

AU - Cartasegna, L

AU - Schygiel, P

AU - Muratore, C

AU - Marino, J

AU - Sosa Liprandi, M I

AU - Guerrero, R. A.

AU - Ramos, H

AU - Mercado, D

AU - Guzmon, L

AU - Beneitez, C

AU - Estepo, J

AU - Torrijos, R.

AU - Retyk, E

AU - Vita, N

AU - Luciardi, H

AU - Casey, M

AU - Orlando, S

AU - Labarta, M B

AU - Santos, D

AU - Amerena, J

AU - Purnell, P

AU - Horowitz, J

AU - Salem, H

AU - Lui, A

AU - Zimmet, L

AU - Roger, S

AU - De Looze, Fred

AU - Lehman, R

AU - Jackson, B

AU - Ashby, D

AU - Heddle, W

PY - 2011/9/15

Y1 - 2011/9/15

N2 - BACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. METHODS: In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. RESULTS: The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P = 0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P = 0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P = 0.42). CONCLUSIONS: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.

AB - BACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. METHODS: In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. RESULTS: The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P = 0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P = 0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P = 0.42). CONCLUSIONS: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.

UR - http://www.scopus.com/inward/record.url?scp=80052825103&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1107039

DO - 10.1056/NEJMoa1107039

M3 - Article

SN - 0028-4793

VL - 365

SP - 981

EP - 992

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 11

ER -

Apixaban versus warfarin in patients with atrial fibrillation

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