- Question
- Can low-dose rivaroxaban added to standard care reduce death, myocardial infarction or stroke in patients with heart failure with reduced ejection fraction, coronary artery disease and sinus rhythm after an episode of worsening heart failure?
- Design
- Randomized, double-blind, placebo-controlled trial enrolling 5022 patients. Median follow-up was 21.1 months.
- Population
- Patients with chronic heart failure, left ventricular ejection fraction of 40% or less, coronary artery disease and elevated natriuretic peptide levels, without atrial fibrillation, treated for an episode of worsening heart failure.
- Intervention
- Rivaroxaban 2.5 mg twice daily on top of standard care.
- Control
- Placebo twice daily on top of standard care.
- Primary outcome
- Composite of all-cause death, myocardial infarction or stroke. The principal safety outcome was fatal bleeding or bleeding into a critical space with potential for permanent disability.
- Results
- The primary endpoint occurred in 626 patients (25.0%) on rivaroxaban and 658 (26.2%) on placebo (HR 0.94; 95% CI 0.84 to 1.05; P=0.27). All-cause mortality did not differ between groups (21.8% vs 22.1%; HR 0.98; 95% CI 0.87 to 1.10).
- Safety
- The principal safety outcome occurred in 18 patients on rivaroxaban and 23 on placebo (HR 0.80; 95% CI 0.43 to 1.49; P=0.48).
- Conclusion
- Rivaroxaban 2.5 mg twice daily did not significantly reduce death, myocardial infarction or stroke compared with placebo in this patient group.
- Why it matters
- It showed that, unlike findings in other coronary disease settings, adding a low-dose anticoagulant did not improve clinical outcomes in heart failure with sinus rhythm, so it did not support routine use in this population.
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 18, 2026