Rivaroxaban with or without aspirin in stable cardiovascular disease
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2017-08-27Author
Eikelboom, John W.
Connolly, Stuart J.
Bosch, Jackie
Dagenais, Gilles R.
Hart, Robert G.
Shestakovska, Olga
Diaz, Rafael
Alings, Marco
Lonn, Eva M.
Anand, Sonia S.
Widimsky, Petr
Hori, Masatsugu
Avezum, Alvaro
Piegas, Leopoldo S.
Branch, Kelley R.H.
Probstfield, Jeffrey
Bhatt, Deepak L.
Zhu, Jun
Liang, Yan
Maggioni, Aldo P.
Lopez-Jaramillo, Patricio
O’Donnell, Martin
Kakkar, Ajay
Fox, Keith A.A.
Parkhomenko, Alexander N.
Ertl, Georg
Störk, Stefan
Keltai, Matyas
Ryden, Lars
Pogosova, Nana
Dans, Antonio L.
Lanas, Fernando
Commerford, Patrick J.
Torp-Pedersen, Christian
Guzik, Tomek J.
Verhamme, Peter B.
Vinereanu, Dragos
Kim, Jae-Hyung
Tonkin, Andrew M.
Lewis, Basil S.
Felix, Camilo
Yusoff, Khalid
Steg, P. Gabriel
Metsarinne, Kaj P.
Cook Bruns, Nancy
Misselwitz, Frank
Chen, Edmond
Leong, Darryl
Yusuf, Salim
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Eikelboom, John W. Connolly, Stuart J.; Bosch, Jackie; Dagenais, Gilles R.; Hart, Robert G.; Shestakovska, Olga; Diaz, Rafael; Alings, Marco; Lonn, Eva M.; Anand, Sonia S.; Widimsky, Petr; Hori, Masatsugu; Avezum, Alvaro; Piegas, Leopoldo S.; Branch, Kelley R.H.; Probstfield, Jeffrey; Bhatt, Deepak L.; Zhu, Jun; Liang, Yan; Maggioni, Aldo P.; Lopez-Jaramillo, Patricio; O’Donnell, Martin; Kakkar, Ajay; Fox, Keith A.A.; Parkhomenko, Alexander N.; Ertl, Georg; Störk, Stefan; Keltai, Matyas; Ryden, Lars; Pogosova, Nana; Dans, Antonio L.; Lanas, Fernando; Commerford, Patrick J.; Torp-Pedersen, Christian; Guzik, Tomek J.; Verhamme, Peter B.; Vinereanu, Dragos; Kim, Jae-Hyung; Tonkin, Andrew M.; Lewis, Basil S.; Felix, Camilo; Yusoff, Khalid; Steg, P. Gabriel; Metsarinne, Kaj P.; Cook Bruns, Nancy; Misselwitz, Frank; Chen, Edmond; Leong, Darryl; Yusuf, Salim (2017). Rivaroxaban with or without aspirin in stable cardiovascular disease. New England Journal of Medicine 377 (14), 1319-1330
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Abstract
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.