Rivaroxaban reduces events in ATLAS-ACS

Bayer has announced that the oral anticoagulant, rivaroxaban, has reduced ischaemic events but increased bleeding in acute coronary syndrome (ACS) patients in the large-scale trial ATLAS-ACS 2 TIMI 51. The … Continue reading Rivaroxaban reduces events in ATLAS-ACS →

Bayer has announced that the oral anticoagulant, rivaroxaban, has reduced ischaemic events but increased bleeding in acute coronary syndrome (ACS) patients in the large-scale trial ATLAS-ACS 2 TIMI 51.

The company said the drug was associated with a statistically significant reduction in the primary composite end point of cardiovascular death, myocardial infarction, and stroke versus placebo. However, it was also associated with a significant increase in the primary safety end point: major bleeding events not associated with coronary artery bypass surgery.

Bayer says the results will be presented “as soon as possible at a forthcoming scientific congress,” and also plans to file for market authorisation by the end of 2011.

This announcement suggests that rivaroxaban has had at least some success in the treatment of ACS, whereas another one of the new oral anticoagulants – apixaban – was discontinued in this indication after showing an unacceptable bleeding rate in the APPRAISE-2 trial.

While these agents have been successful in venous thrombosis and in the prevention of stroke in atrial fibrillation patients, their use in ACS is more difficult as they are being added onto dual antiplatelet therapy, so the bleeding risks are much higher. The big question is now whether the reduction in ischaemic events with rivaroxaban outweighs the increased bleeding risk.

European approval recommendation for AF and DVT

• Separately, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for rivaroxaban for two new indications:
• the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation, based on the ROCKET-AF trial
• the treatment of venous thromboembolism, deep vein thrombosis, and pulmonary embolism, based on the EINSTEIN-DVT and EINSTEIN Extension studies.