Rivaroxaban with or without Aspirin in Stable Cardiovascular
Disease

J 2017

Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease

EIKELBOOM, J.W., S.J. CONNOLLY, J. BOSCH, G.R. DAGENAIS, R.G. HART et. al.

Basic information

Original name

Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease

Authors

EIKELBOOM, J.W., S.J. CONNOLLY, J. BOSCH, G.R. DAGENAIS, R.G. HART, O. SHESTAKOVSKA, R. DIAZ, M. ALINGS, E.M. LONN, S.S. ANAND, P. WIDIMSKY, M. HORI, A. AVEZUM, L.S. PIEGAS, K.R.H. BRANCH, J. PROBSTFIELD, D.L. BHATT, J. ZHU, Y. LIANG, A.P. MAGGIONI, P. LOPEZ-JARAMILLO, M. O´DONNELL, A.K. KAKKAR, K.A.A. FOX, A.N. PARKHOMENKO, G. ERTL, S. STORK, M. KELTAI, L. RYDEN, N. POGOSOVA, A.L. DANS, F. LANAS, P.J. COMMERFORD, C. TORP-PEDERSEN, T.J. GUZIK, P.B. VERHAMME, D. VINEREANU, J.H. KIM, A.M. TONKIN, B.S. LEWIS, C. FELIX, K. YUSOFF, P.G. STEG, K.P. METSARINNE, N.C. BRUNS, F. MISSELWITZ, E. CHEN, D. LEONG and S. YUSUF

Edition

New England Journal of Medicine, Waltham, Massachussetts Medical Society, 2017, 0028-4793

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 79.260

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1056/NEJMoa1709118

UT WoS

000412375000012

Abstract

V originále

BACKGROUND We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. METHODS In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months. RESULTS The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P< 0.001; z = -4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P< 0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P = 0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban- alone group. CONCLUSIONS Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events.

Citovat

@article{1399095,
   author = {Eikelboom, J.W. and Connolly, S.J. and Bosch, J. and Dagenais, G.R. and Hart, R.G. and Shestakovska, O. and Diaz, R. and Alings, M. and Lonn, E.M. and Anand, S.S. and Widimsky, P. and Hori, M. and Avezum, A. and Piegas, L.S. and Branch, K.R.H. and Probstfield, J. and Bhatt, D.L. and Zhu, J. and Liang, Y. and Maggioni, A.P. and LopezandJaramillo, P. and O´Donnell, M. and Kakkar, A.K. and Fox, K.A.A. and Parkhomenko, A.N. and Ertl, G. and Stork, S. and Keltai, M. and Ryden, L. and Pogosova, N. and Dans, A.L. and Lanas, F. and Commerford, P.J. and TorpandPedersen, C. and Guzik, T.J. and Verhamme, P.B. and Vinereanu, D. and Kim, J.H. and Tonkin, A.M. and Lewis, B.S. and Felix, C. and Yusoff, K. and Steg, P.G. and Metsarinne, K.P. and Bruns, N.C. and Misselwitz, F. and Chen, E. and Leong, D. and Yusuf, S. and Špinar, Jindřich and Pařenica, Jiří and Lokaj, Petr},
   article_location = {Waltham},
   article_number = {14},
   doi = {http://dx.doi.org/10.1056/NEJMoa1709118},
   language = {eng},
   issn = {0028-4793},
   journal = {New England Journal of Medicine},
   title = {Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease},
   url = {http://dx.doi.org/10.1056/NEJMoa1709118},
   volume = {377},
   year = {2017}
}

TY  - JOUR
ID  - 1399095
AU  - Eikelboom, J.W. - Connolly, S.J. - Bosch, J. - Dagenais, G.R. - Hart, R.G. - Shestakovska, O. - Diaz, R. - Alings, M. - Lonn, E.M. - Anand, S.S. - Widimsky, P. - Hori, M. - Avezum, A. - Piegas, L.S. - Branch, K.R.H. - Probstfield, J. - Bhatt, D.L. - Zhu, J. - Liang, Y. - Maggioni, A.P. - Lopez-Jaramillo, P. - O´Donnell, M. - Kakkar, A.K. - Fox, K.A.A. - Parkhomenko, A.N. - Ertl, G. - Stork, S. - Keltai, M. - Ryden, L. - Pogosova, N. - Dans, A.L. - Lanas, F. - Commerford, P.J. - Torp-Pedersen, C. - Guzik, T.J. - Verhamme, P.B. - Vinereanu, D. - Kim, J.H. - Tonkin, A.M. - Lewis, B.S. - Felix, C. - Yusoff, K. - Steg, P.G. - Metsarinne, K.P. - Bruns, N.C. - Misselwitz, F. - Chen, E. - Leong, D. - Yusuf, S. - Špinar, Jindřich - Pařenica, Jiří - Lokaj, Petr
PY  - 2017
TI  - Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease
JF  - New England Journal of Medicine
VL  - 377
IS  - 14
SP  - 1319-1330
EP  - 1319-1330
PB  - Massachussetts Medical Society
SN  - 00284793
UR  - http://dx.doi.org/10.1056/NEJMoa1709118
L2  - http://dx.doi.org/10.1056/NEJMoa1709118
N2  - BACKGROUND We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. METHODS In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months. RESULTS The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P< 0.001; z = -4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P< 0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P = 0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban- alone group. CONCLUSIONS Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events.
ER  -

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