Xarelto ( Rivaroxaban ), a novel oral anticoagulant, has been approved by the European Commission ( EC ) for the prevention of atherothrombotic events ( cardiovascular death, myocardial infarction or stroke ) after an acute coronary syndrome ( ACS ) in adult patients with elevated cardiac biomarkers at a dose of 2.5 mg twice-daily ( BID ) in combination with standard antiplatelet therapy.
Arterial blood clots, which may lead to a recurrence after an ACS event, are formed through the dual pathways of platelet activation and thrombin generation. Standard antiplatelet therapy only targets the platelet activation pathway of clot formation. Rivaroxaban targets factor Xa, a key trigger of thrombin generation.
The approval of Rivaroxaban in this indication is based on clinical findings of the pivotal Phase III ATLAS ACS 2-TIMI 51 study of more than 15,500 patients.
The study has demonstrated that the addition of Rivaroxaban 2.5 mg BID to standard antiplatelet therapy ( low-dose Aspirin with or without a thienopyridine [ Clopidogrel or Ticlopidine ] ), 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 and of intracranial haemorrhage ( ICH ) 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 ( ICH ) or fatal bleeding.
Based on the ATLAS ACS 2-TIMI 51 study findings, the 2012 European Society of Cardiology ( ESC ) Guidelines recommend that treatment with Rivaroxaban 2.5 mg BID be considered for patients with ST-segment elevation myocardial infarction ( STEMI ) who are at low bleeding risk and are on antiplatelet therapy with Acetylsalicylic acid ( Aspirin ) and Clopidogrel ( Plavix ).
Acute coronary syndrome is a complication of coronary heart disease; ACS occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart. This disruption of blood flow can be the direct cause of a myocardial infarction, or precipitate severe pain in the chest ( unstable angina ), a condition indicating that a myocardial infarction may soon occur. Higher levels of cardiac biomarkers are associated with heart injury, and laboratory testing of these biomarkers is routinely undertaken in clinical practice to confirm an ACS. ( Xagena )
Source: Bayer HealthCare, 2013