Xarelto: first novel anticoagulant licensed for ACS

Bayer has launched a new 2.5mg strength of Xarelto (rivaroxaban) for the prevention of atherothrombotic events after acute coronary syndromes (ACS) in patients with elevated cardiac biomarkers.

Rivaroxaban is a selective direct factor Xa inhibitor. | SCIENCE PHOTO LIBRARY
Rivaroxaban is a selective direct factor Xa inhibitor. | SCIENCE PHOTO LIBRARY

In ACS patients, rivaroxaban is administered at a dose of 2.5mg twice daily in combination with aspirin 75—100mg daily, with or without clopidogrel 75mg daily.1


The safety and efficacy of rivaroxaban was evaluated in 15,526 patients with a recent ACS, defined as ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) or unstable angina.1

When added to standard therapy including low-dose aspirin, rivaroxaban 2.5mg twice daily significantly reduced the primary composite endpoint of death from cardiovascular causes, MI or stroke compared with placebo, with rates of 9.1% and 10.7%, respectively, over 24 months (HR 0.84, 95% CI 0.72—0.97, p=0.02).2

Rivaroxaban also significantly reduced the risk of death from cardiovascular causes (2.7%, vs 4.1% for placebo, p=0.002) and death from any cause (2.9%, vs 4.5% for placebo, p=0.002) over 24 months.2


Rivaroxaban increased the risk of major bleeding not associated with coronary-artery bypass grafting (1.8%, vs 0.6% with placebo; HR 3.46, 95% CI 2.08—5.77, p<0.001), as well as the rate of bleeding requiring medical attention and the rate of intracranial haemorrhage. However, there was no statistically significant difference in fatal bleeding.2

NICE decision pending

A technology appraisal assessing the clinical and cost effectiveness of rivaroxaban for secondary prevention in ACS is due to be published in March 2015.


  1. Xarelto Summary of Product Characteristics, July 2014.
  2. Mega JL et al. N Engl J Med 2012; 366:9—19.

View Xarelto drug record

Further information: Bayer plc

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