Background: After an acute coronary syndrome(ACS), patients continue to be at risk of major adverse cardiovascular events (MACE) despite the standard treatment. The risk of MACE may be secondary to thrombin, which remains elevated after ACS.We evaluated the safety and efficacy of the novel oral anticoagulant (NOAC), factor Xa inhibitor rivaroxaban.
Methods: In our study, we randomly assigned 100 patients with a recent ACS to receive the once-daily dose of 2.5mg of rivaroxaban or placebo in addition to dual antiplatelet therapy for six months. The primary efficacy endpoint was a composite of death from cardiovascular events, myocardial infarction, and stroke, the secondary endpoint was death from cardiovascular events, myocardial infarction, or stroke with assessing the safety (risk of bleeding).
Results: Rivaroxaban significantly reduced the primary efficacy endpoint, as compared with placebo, with respective rates of 4% and 22% (P=0.007). Regarding secondary endpoint, the 2.5mg dose of rivaroxaban reduced the rates of death from cardiovascular causes (0% versus 8%, P=0.041). As compared with placebo, rivaroxaban increased the rates of minor bleeding (12% vs. 2%, P=0.049), with no major or fatal bleeding had been recorded.
Conclusion: In patients with a recent acute coronary syndrome, rivaroxaban reduced the risk of the composite endpoint of death from cardiovascular causes, myocardial infarction, or stroke. Rivaroxaban increased the risk of minor bleeding but not the risk of major or fatal bleeding.
Keywords: Acute coronary syndrome, novel oral anticoagulants, rivaroxaban