Rivaroxaban in patients with a recent acute coronary syndrome.

ATLAS ACS-2, TIMI 51

In patients with a recent acute coronary syndrome, rivaroxaban at the doses of either 2.5 mg or 5 mg, as compared to placebo, reduced the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke, with respective rates of 8.9% and 10.7% (HR 0.84, 95% CI 0.74-0.96, p = 0.008), with significant improvement for both the 2.5 mg dose (9.1% vs. 10.7%, p = 0.02) and 5 mg dose (8.8% vs. 10.7%, p = 0.03). Rivaroxaban 2.5 mg reduced the rates of death from cardiovascular causes (2.7 vs. 4.1, p = 0.002) and from any causes (2.9% vs. 4.5%, p = 0.002), a survival benefit that was not seen with the 5 mg dose. Rivaroxaban, as compared to placebo, increased the rates of major bleeding unrelated to CABG (2.1% vs. 0.6%, p < 0.001) and ICH (0.6% vs. 0.2%, p = 0.009), without a significant increase in fatal bleeding (0.3% vs. 0.2%, p = 0.66) or other adverse events. Rivaroxaban 2.5 mg, as compared to 5 mg dose, resulted in fewer fatal bleeding events (0.1% vs. 0.4%, p = 0.04).