Bayer AG announced today that the ATLAS ACS TIMI 51 trial of rivaroxaban (Xarelto, Bayer and Johnson and Johnson) in patients with acute coronary syndrome (ACS) had met its primary efficacy endpoint, “showing 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 there was a statistically significant increase in rivaroxaban-treated patients 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 anticoagulant 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 based upon 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.
- ATLAS ACS TIMI 51 on ClinicalTrials.Gov
- ATLAS ACS TIMI 51 on the TIMI Study Group website
- American Heart Journal Rationale and Design Paper
Here is the text of the Bayer statement:
Bayer AG: Phase III Study of Bayer’s Rivaroxaban in Patients with Acute Coronary Syndrome Meets Primary Efficacy Endpoint Leverkusen, Germany, September 29, 2011
Leverkusen, Germany, September 29, 2011
Bayer AG announced today that the double blind, placebo controlled Phase III ATLAS ACS TIMI 51 clinical trial of Rivaroxaban plus standard therapy has met its primary efficacy endpoint, showing 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. For the primary safety endpoint, defined as major bleeding events not associated with Coronary Artery Bypass Graft surgery according to the TIMI-classification, there was a statistically significant increase in such events in patients receiving Rivaroxaban versus placebo. It is intended to present these data as soon as possible at a forthcoming scientific congress as well as to file for market authorization by the end of this year.