A major subgroup analysis from the ATLAS ACS 2-TIMI 51 study of 7,817 patients with acute coronary syndrome (ACS) and a recent ST-segment elevation myocardial infarction (STEMI) demonstrated that German drug major Bayer’s (BAYN: DE) oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice daily, when added to standard antiplatelet therapy, provides a significant mortality benefit. The drug is under development with US partner Johnson & Johnson (NYSE: JNJ).
The analysis showed that adding rivaroxaban to standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint (cardiovascular death, myocardial infarction (MI) or stroke) compared to standard antiplatelet therapy alone. Rates of TIMI major bleeding (not related to coronary artery bypass graft (CABG) surgery) were increased with rivaroxaban. But importantly, rivaroxaban did not increase the rate of fatal bleeding. Overall, the addition of rivaroxaban 2.5 mg twice daily significantly reduced mortality, including cardiovascular death and all cause death, in comparison to standard therapy alone. These results were presented today at the 2012 European Society of Cardiology congress in Darmstadt, Germany, by Jessica Mega from the TIMI Study Group.
"Approximately 30% of ACS patients have a STEMI diagnosis and the risk of life-threatening secondary events for STEMI patients is highest at hospitalisation. However, this risk remains high even after the patient has been stabilised and leaves the hospital," said Michael Gibson, senior investigator of the TIMI Study Group, Harvard Medical School, and the principal investigator in the ATLAS ACS studies of rivaroxaban. "These data confirm that adding twice-daily rivaroxaban to standard therapy once patients are stabilised, leads to a significant reduction of this elevated mortality risk," he added.
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