Rivaroxaban at 2.5mg twice daily was no assocaited with an improvement in rates of death, myocardial infarction (MI), or stroke in patients with worsening chronic heart failure (HF), according to researchers from the COMMANDER HF trial.
The randomized, double-blind trial included 5,022 patients with chronic HF, LVEF of 40% or less, coronary heart disease, no atrial fibrillation, and elevated plasma concentrations. Patients were randomly assigned to either rivaroxaaban 2.5 mg twice daily or placebo, with a composite endpoint of death from any cause, MI, or stroke. Patients were followed up for a mean of 21.1 months.
COMMANDER HF: Rivaroxaban did not have a significant effect on the composite outcome of death, myocardial infarction, or stroke among patients with heart failure, coronary artery disease, and no atrial fibrillation. https://t.co/vtsjwJ72o3 #ESCCongress pic.twitter.com/If7NJw7GcU
— NEJM (@NEJM) August 27, 2018
According to the results, the endpoint occurred in 25% of the 2,507 patients taking rivaroxaban, and 26.2% in the 2,515-patient placebo group (P=0.27). The researchers also reported no significant differences in all-cause mortality between the study groups (21.8% rivaroxaban vs. 22.1% placebo; HR=0.98; 95% CI, 0.87 to 1.10). There were also no reported differences between study groups for the primary safety outcome (P=0.48).
“In patients with recent worsening of chronic heart failure and reduced ejection fraction who also had underlying coronary artery disease and were not in atrial fibrillation, low-dose rivaroxaban added to guideline-based therapy was not associated with a lower rate of the composite outcome of death from any cause, MI, or stroke than placebo, nor did it favorably influence the rate of rehospitalization for HF,” the authors wrote in their conclusion.
Is it just me or are the NOACs really getting flogged with extended indication trials? I'm unexcited by all… This one in @NEJM looked at Rivaroxaban in Patients with #HeartFailure, Sinus Rhythm, and Coronary Disease https://t.co/Z2ZHFiSUpa
— Cia Connell (@CiaConnell) August 28, 2018
— ATRIUM Cardiology (@ATRIUMRx) September 4, 2018
While it’s unfortunate we haven’t found an additional therapy in patients with such poor outcomes, the use of anti-coagulation in those with HFrEF and sinus rhythm hasn’t been effective in the past (e.g. WARCEF Trial) – unsurprising result https://t.co/tPMJMcqP0w
— Michael Diamant (@MDMichael13) August 28, 2018
— Ido Weinberg, MD (@Angiologist) August 27, 2018
Source: New England Journal of Medicine