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.
- Xarelto Summary of Product Characteristics, July 2014.