Rivaroxaban may reduce thromboembolic risk in HF patients
Use of the oral anticoagulant rivaroxaban at a low dose may reduce the risk of thromboembolic events* in patients with heart failure (HF), according to a post hoc analysis of the COMMANDER HF** trial.
The study enrolled 5,000 high-risk individuals (mean age 67 years, 22 percent female) with chronic HF who experienced an episode of worsening (ie, HF hospitalization) within 21 days of hospital discharge. Participants were randomized 1:1 to receive rivaroxaban 2.5 mg twice daily or placebo on top of standard-of-care therapy. [AHA 2018, abstract 19574]
Kaplan-Meier estimates revealed a reduction in thromboembolic events with rivaroxaban vs placebo (13.1 percent vs 15.5 percent, hazard ratio [HR], 0.83, 95 percent confidence interval [CI], 0.72–0.96; p=0.013), translating to an event rate of 7.0 and 8.5/100 patient years, respectively, over a median follow-up of 19.6 months.
“We tested for homogeneity but there was no evidence that [the endpoints] were different. They were all going in a similar direction. The main ones were (myocardial infarction [MI]) and stroke,” said Dr Barry Greenberg from the University of California in San Diego, California, US, pertaining to the reductions observed in the subgroup results specifically for MI (3.9 percent vs 4.7 percent, HR, 0.83, 95 percent CI, 0.63–1.08) and ischaemic stroke (1.6 percent vs 2.5 percent, HR, 0.64, 95 percent CI, 0.43–0.95).
The results support the findings from the ATLAS ACS 2 TIMI 51*** and COMPASS# trials which demonstrated reductions in cardiovascular (CV) death, MI, and stroke with rivaroxaban. [N Engl J Med 2012;366:9-19; N Engl J Med 2017;377:1319-1330] While both trials focused on patients post-MI, or with unstable angina or stable coronary artery or peripheral vascular disease, patients with HF were also included. [Am J Cardiol 2018;122:1896-1901]
Initial COMMANDER HF findings demonstrated no improvement in all-cause mortality, MI, and stroke (HR, 0.94) and CV death and HF hospitalization (HR, 1.01). Therefore, it is important to establish a treatment regimen for chronic HF given the high rates of readmission and death following an episode, said Greenberg. [Eur J Heart Fail 2013;15:808-817]
Greenberg called for a prospective analysis to elucidate the findings and further establish the role of rivaroxaban in treating HF. “[Considering] other studies … that have [evaluated] patients with atherosclerotic disease and showed a very favourable signal for low-dose rivaroxaban in reducing events, what [our] data shows us is that [HF] … would not be a reason to withhold rivaroxaban in this population. [Further] studies [may determine] whether [rivaroxaban] is a favourable drug for patients with HF alone.”
Moreover, it is still premature to say that anybody with HF should be on rivaroxaban, noted Greenberg. “I’d key in on the atherosclerotic background and put this in the context of the other studies … [There might be] a very strong signal that [rivaroxaban] does have benefits.”