September 29th, 2011

Rivaroxaban Meets Primary Endpoint in ATLAS ACS TIMI 51

Bayer AG announced today that in the ATLAS ACS TIMI 51 trial, rivaroxaban (Xarelto, Bayer and Johnson & Johnson) had met the primary efficacy endpoint  in patients with acute coronary syndrome (ACS). The drug was associated with “a statistically significant reduction in the rate of events for the primary composite endpoint of cardiovascular death, myocardial infarction and stroke in patients with ACS, compared to standard therapy plus placebo.”

However, the company also announced that rivaroxaban-treated patients showed a statistically significant increase in major bleeding events not associated with CABG surgery, the primary safety endpoint of the trial. The results of the trial will be presented at a scientific meeting in the future, the company said.

In July, the announcement of the APPRAISE 2 results with apixaban in ACS appeared to dash hopes that oral anticoagulation therapy could be added to dual antiplatelet therapy in ACS. One difference that may turn out to be key is that patients enrolled in ATLAS ACS were stratified on the basis of whether the investigator planned to give aspirin alone or aspirin plus a thienopyridine such as clopidogrel or prasugrel. The Bayer announcement did not include any information about outcomes in the different strata.

At the recent FDA advisory committee panel about the ROCKET AF trial, many panel members expressed concern about the once-daily dosage of rivaroxaban used in ROCKET AF. In ATLAS ACS, by contrast, rivaroxaban was given twice daily, as either a 2.5-mg or 5-mg pill.

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