Abstract 16014: Evaluation of Cardiac Events in ATLAS ACS 2-TIMI 51
Introduction: The ATLAS ACS 2-TIMI 51 trial was designed to test two low doses of the factor Xa inhibitor rivaroxaban in patients with a recent ACS. Both doses reduced the primary efficacy endpoint of cardiovascular death, MI, or stroke, as compared with placebo. The outcomes were driven by a reduction in cardiovascular death with the 2.5 mg twice daily dose and a reduction in MI with the 5 mg twice daily dose.
Objective: To evaluate this apparent divergence between the two doses, we further assessed the types of cardiac events in the study.
Methods: MI and cause of death in ATLAS ACS 2-TIMI 51 were independently adjudicated by a Clinical Events Committee. Cardiac events in this analysis included nonfatal MI, fatal MI, and fatal complications related to ischemic heart disease (deaths that were sudden/unwitnessed or deaths that were due to CHF/cardiogenic shock or arrhythmia).
Results: In the rivaroxaban 2.5 mg twice daily and rivaroxaban 5 mg twice daily treatment groups, there were 172 and 137 non-fatal MIs, 17 and 27 fatal MIs, and 54 and 77 fatal complications related to ischemic heart disease, respectively, among subjects stratified to receive dual antiplatelet therapy. The total number of cardiac events (non-fatal MI + fatal MI + fatal complications related to ischemic heart disease) in the two groups receiving rivaroxaban were N=243 and N=241, respectively; each was significantly lower than the placebo group (N=300) (P=0.02, Table).
Conclusions: When serious ischemic events are considered more broadly (fatal and non-fatal MI as well as fatal complications related to ischemia), both doses of rivaroxaban are associated with a similar event reduction compared with placebo.
- © 2012 by American Heart Association, Inc.