- Question
- Can low-dose rivaroxaban, a factor Xa inhibitor added to standard care, improve cardiovascular outcomes in patients with a recent acute coronary syndrome?
- Design
- Double-blind, placebo-controlled, randomized trial of 15526 patients with a recent acute coronary syndrome. Patients were assigned to rivaroxaban 2.5 mg, rivaroxaban 5 mg or placebo, treated for a mean of 13 months and up to 31 months.
- Population
- Patients with a recent acute coronary syndrome (myocardial infarction with or without ST-segment elevation, or unstable angina).
- Intervention
- Oral rivaroxaban twice daily, at a dose of either 2.5 mg or 5 mg.
- Control
- Placebo twice daily.
- Primary outcome
- Composite of death from cardiovascular causes, myocardial infarction, or stroke.
- Results
- Rivaroxaban reduced the primary endpoint versus placebo (8.9% vs. 10.7%; HR 0.84; 95% CI 0.74 to 0.96; P=0.008). The 2.5-mg dose also reduced cardiovascular death (2.7% vs. 4.1%; P=0.002) and all-cause death (2.9% vs. 4.5%; P=0.002), a survival benefit not seen with the 5-mg dose.
- Safety
- Rivaroxaban increased major bleeding not related to bypass surgery (2.1% vs. 0.6%; P<0.001) and intracranial hemorrhage (0.6% vs. 0.2%; P=0.009), without a significant increase in fatal bleeding (0.3% vs. 0.2%; P=0.66). The 2.5-mg dose had fewer fatal bleeds than the 5-mg dose (0.1% vs. 0.4%; P=0.04).
- Conclusion
- In patients with a recent acute coronary syndrome, rivaroxaban reduced the composite of cardiovascular death, myocardial infarction or stroke, at the cost of more major bleeding and intracranial hemorrhage but no increase in fatal bleeding.
- Why it matters
- It showed that adding a low-dose anticoagulant to usual antithrombotic therapy can reduce ischemic events after an acute coronary syndrome, balancing that benefit against higher bleeding risk and highlighting the low dose as the more favorable one.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 10, 2026