Rivaroxaban in patients with a recent acute coronary syndrome

Mega, Jessica L., Braunwald, Eugene, Wiviott, Stephen D., Bassand, Jean-Pierre, Bhatt, Deepak L., Bode, Christoph, Burton, Paul, Cohen, Marc, Cook-Bruns, Nancy, Fox, Keith A. A., Goto, Shinya, Murphy, Sabina A., Plotnikov, Alexei N., Schneider, David, Sun, Xiang, Verheugt, Freek W. A. and Gibson, C. Michael (2012) Rivaroxaban in patients with a recent acute coronary syndrome. New England Journal of Medicine, 366 1: 9-19. doi:10.1056/NEJMoa1112277

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Author Mega, Jessica L.
Braunwald, Eugene
Wiviott, Stephen D.
Bassand, Jean-Pierre
Bhatt, Deepak L.
Bode, Christoph
Burton, Paul
Cohen, Marc
Cook-Bruns, Nancy
Fox, Keith A. A.
Goto, Shinya
Murphy, Sabina A.
Plotnikov, Alexei N.
Schneider, David
Sun, Xiang
Verheugt, Freek W. A.
Gibson, C. Michael
Title Rivaroxaban in patients with a recent acute coronary syndrome
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
Publication date 2012-01-05
Year available 2012
Sub-type Article (original research)
DOI 10.1056/NEJMoa1112277
Open Access Status File (Publisher version)
Volume 366
Issue 1
Start page 9
End page 19
Total pages 11
Place of publication Waltham, MA, United States
Publisher Massachusetts Medical Society
Language eng
Formatted abstract
Background: Acute coronary syndromes arise from coronary atherosclerosis with superimposed thrombosis. Since factor Xa plays a central role in thrombosis, the inhibition of factor Xa with low-dose rivaroxaban might improve cardiovascular outcomes in patients with a recent acute coronary syndrome.

Methods: In this double-blind, placebo-controlled trial, we randomly assigned 15,526 patients with a recent acute coronary syndrome to receive twice-daily doses of either 2.5 mg or 5 mg of rivaroxaban or placebo for a mean of 13 months and up to 31 months. The primary efficacy end point was a composite of death from cardiovascular causes, myocardial infarction, or stroke.

Results: Rivaroxaban significantly reduced the primary efficacy end point, as compared with placebo, with respective rates of 8.9% and 10.7% (hazard ratio in the rivaroxaban group, 0.84; 95% confidence interval [CI], 0.74 to 0.96; P = 0.008), with significant improvement for both the twice-daily 2.5-mg dose (9.1% vs. 10.7%, P = 0.02) and the twice-daily 5-mg dose (8.8% vs. 10.7%, P = 0.03). The twice-daily 2.5-mg dose of rivaroxaban reduced the rates of death from cardiovascular causes (2.7% vs. 4.1%, P = 0.002) and from any cause (2.9% vs. 4.5%, P = 0.002), a survival benefit that was not seen with the twice-daily 5-mg dose. As compared with placebo, rivaroxaban increased the rates of major bleeding not related to coronary-artery bypass grafting (2.1% vs. 0.6%, P<0.001) and intracranial hemorrhage (0.6% vs. 0.2%, P = 0.009), without a significant increase in fatal bleeding (0.3% vs. 0.2%, P = 0.66) or other adverse events. The twice-daily 2.5-mg dose resulted in fewer fatal bleeding events than the twice-daily 5-mg dose (0.1% vs. 0.4%, P = 0.04).

Conclusions: In patients with a recent acute coronary syndrome, rivaroxaban reduced the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke. Rivaroxaban increased the risk of major bleeding and intracranial hemorrhage but not the risk of fatal bleeding. (Funded by Johnson & Johnson and Bayer Healthcare; ATLAS ACS 2-TIMI 51 ClinicalTrials.gov number, NCT00809965.) 
Keyword Medicine, General & Internal
General & Internal Medicine
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 801 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 928 times in Scopus Article | Citations
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