Rivaroxaban in patients with heart failure, sinus rhythm, and coronary disease
A new study investigated adding rivaroxaban to standard care for the treatment of patients with recent worsening of chronic heart failure, reduced ejection fraction, and coronary artery disease.
A new study investigated adding rivaroxaban to standard care for the treatment of patients with recent worsening of chronic heart failure, reduced ejection fraction, and coronary artery disease. For the trial, more than 5,000 patients with chronic heart failure, a left ventricular ejection fraction of 40% or less, coronary artery disease, and elevated plasma concentrations of natriuretic peptides and who did not have atrial fibrillation were randomized to receive rivaroxaban 2.5 mg twice daily or placebo in addition to standard care following treatment for an episode of worsening heart failure. The primary efficacy endpoint—a composite of death from any cause, myocardial infarction, or stroke—occurred in 25.0% of the rivaroxaban patients and 26.2% of the placebo recipients over a median followup of about 21 months. There was no meaningful difference in all-cause mortality between the two groups. Meanwhile, the principal safety outcome—fatal bleeding or bleeding into a critical space with a potential for causing permanent disability—was reported in 18 patients in the rivaroxaban group and 23 in the placebo group. The researchers concluded that "rivaroxaban was not found to have a benefit with regard to the primary outcome," suggesting that "the most likely reason for the failure of rivaroxaban at a dose of 2.5 mg twice daily to improve cardiovascular outcomes in the current trial is that thrombin-mediated events are not the major driver of heart failure–related events in patients with recent hospitalization for heart failure."