The Anti-Xa Therapy to Lower cardiovascular events in Addition to Standard therapy in subjects with Acute Coronary Syndromes - Thrombolysis In Myocardial Infarction 51 trial evaluated twice-daily rivaroxaban at two doses in patients who recently experienced an ACS.
Design: Double-blind, placebo-controlled, randomized
Results: Rivaroxaban reduced the risk for the composite endpoint of death from cardiovascular causes, MI or stroke vs. placebo (8.9% vs. 10.7%, respecitvely; HR = 0.84; 95% CI, 0.74-0.96). Improvements were seen with both 2.5 mg (9.1% vs. 10.7%, P = .02) and 5 mg (8.8% vs. 10.7%, P = .03). Rivaroxaban increased the rates for non-fatal major bleeding (2.1% vs. 0.6%, P < .001) and intracranial hemorrhage (0.6% vs. 0.2%, P = .009) but not for fatal bleeding (0.3% vs. 0.2%, P = .66).
Mega JL, et al. N Engl J Med. 2011;doi:10.1056/NEJMoa1112277.
Healio/Cardiology News Coverage:
ATLAS ACS: Adding rivaroxaban to antiplatelet therapy reduced death rates in ACS