Zannad F, et al. - Researchers tested the premise that reducing thrombin generation and improving the outcomes for patients with worsening chronic heart failure and underlying coronary artery disease could be achieved with rivaroxaban (a factor Xa inhibitor) treatment. Among patients with worsening chronic heart failure, reduced left ventricular ejection fraction, coronary artery disease, and no atrial fibrillation, findings did not suggest an association of rivaroxaban at a dose of 2.5 mg twice daily with a significantly lower rate of death, myocardial infarction, or stroke vs placebo.

Methods

• In this double-blind, randomized trial, experts randomly assigned 5,022 patients, who had 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 to receive rivaroxaban at a dose of 2.5 mg twice daily or placebo in addition to standard care after treatment for an episode of worsening heart failure.
• The composite of death from any cause, myocardial infarction, or stroke was the primary efficacy outcome.
• Fatal bleeding or bleeding into a critical space with a potential for causing permanent disability was the principal safety outcome.

Results

• As per data, over a median follow-up period of 21.1 months, the primary end point occurred in 626 (25.0%) of 2,507 patients assigned to rivaroxaban and in 658 (26.2%) of 2,515 patients assigned to placebo (hazard ratio, 0.94; 95% confidence interval [CI], 0.84 to 1.05; P=0.27).
• Researchers did not note any significant difference in all-cause mortality between the rivaroxaban group and the placebo group (21.8% and 22.1%, respectively; hazard ratio, 0.98; 95% CI, 0.87 to 1.10).
• They noted the occurrence of principal safety outcome (fatal bleeding or bleeding into a critical space with a potential for causing permanent disability) in 18 patients who took rivaroxaban and in 23 who took placebo (hazard ratio, 0.80; 95% CI, 0.43 to 1.49; P=0.48).