Xarelto recommended for approval in the EU for the prevention of atherothrombotic events after an acute coronary syndrome
The European Committee for Medicinal Products for Human Use ( CHMP ) has recommended approval of oral anticoagulant Xarelto ( Rivaroxaban ) 2.5 mg twice-daily in combination with standard antiplatelet therapy for the prevention of atherothrombotic events ( myocardial infarction, cardiovascular death or stroke ) after an acute coronary syndrome ( ACS ) in adult patients with elevated cardiac biomarkers. Elevated cardiac biomarkers confirm the ACS and characterize patients at high risk of recurrent events.
Major cardiovascular events including cardiovascular death rates remain high for patients with acute coronary syndrome who currently only receive standard antiplatelet therapy following hospital discharge. Standard antiplatelet therapy targets only one pathway of clot formation, platelet activation. However, arterial blood clots are formed through the dual pathways of both platelet activation and thrombin generation. Furthermore, thrombin levels remain elevated following an ACS event and need to be addressed in the long-term.
Data from the pivotal Phase III ATLAS ACS 2-TIMI 51 study of more than 15,500 patients demonstrated that the addition of Rivaroxaban 2.5 mg BID to standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction or stroke in patients after a recent acute coronary syndrome compared to those who received standard antiplatelet therapy alone.
Rates of TIMI ( Thrombolysis In Myocardial Infarction ) major bleeding events not associated with coronary artery bypass graft ( CABG ) surgery were low overall, yet increased with the addition of Rivaroxaban. But importantly, there was no increase observed with Rivaroxaban in the risk of fatal intracranial haemorrhage or fatal bleeding.
Acute coronary syndrome is a complication of coronary heart disease which is the single most common cause of death worldwide and one of the most prevalent non-communicable diseases in the world.
Acute coronary syndrome occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart. This disruption of blood flow can directly cause a heart attack, or cause severe pain in the chest ( unstable angina ), a condition indicating that a heart attack may soon occur.
Higher levels of cardiac biomarkers are associated with heart injury. Laboratory testing of cardiac biomarkers is already routinely done in clinical practice to confirm acute coronary syndrome.
Source: Bayer HealthCare, 2013