Xarelto, in combination with aspirin, is now approved to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI), and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). It is the first, and only, Factor Xa inhibitor to be approved for this indication.

The dose of Xarelto for cardiovascular risk reduction is 2.5 mg twice daily in combination with aspirin 81 mg daily or clopidogrel 75 mg daily. This combination should not be considered for patients at high risk of bleeding or those who require chronic therapeutic anticoagulation for another indication.

The results of the COMPASS trial led to the new indication for Xarelto. The trial evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. The study found that among patients with stable atherosclerotic vascular disease:

• Rivaroxaban 2.5 mg twice daily + aspirin 100 mg daily had fewer adverse cardiovascular events and more major bleeding events vs. aspirin alone
• Rivaroxaban + aspirin vs. aspirin alone was associated with a reduction in all strokes and ischemic strokes
• Rivaroxaban alone was not more effective than aspirin alone
• Rivaroxaban alone vs. aspirin alone was not associated with a reduction in all strokes