Rivaroxaban May Lower Thromboembolic Risk: Analysis

Rivaroxaban (Xarelto, Janssen) added to background antiplatelet therapy may reduce the risk for thromboembolic events, a new analysis suggested.

The post-hoc analysis for the COMMANDER-HF trial, published in JAMA Cardiology, looked at the trial population of 5,022 patients with worsening chronic heart failure (HF) with reduced ejection fraction, coronary artery disease (CAD), and sinus rhythm. Patients were receiving standard care for HF and CAD, and were randomized (1:1) to either rivaroxaban or placebo. The COMMANDER-HF primary endpoint was all-cause mortality, myocardial infarction, or stroke, which the trial showed did not differ between those taking rivaroxaban and placebo (while showing some other advantages).

The post-hoc analysis focused on whether low-dose rivaroxaban was linked with reduced thromboembolic events. The authors developed a thromboembolic composite defined as “(1) myocardial infarction, ischemic stroke, sudden/unwitnessed death, symptomatic pulmonary embolism, or symptomatic deep venous thrombosis; or (2) all of the previous components except sudden/unwitnessed deaths.”

Results As Expected

The analysis results revealed that fewer patients taking rivaroxaban had thromboembolic events (including sudden/unwitnessed deaths (HR=0.83; 95% CI, 0.72 to 0.96; P=0.01). Thromboembolic event rates were similar between groups when excluding sudden/unwitnessed deaths (HR=0.80; 95% CI, 0.64 to 0.98; P=0.04).

“Rivaroxaban may reduce the risk of thromboembolic events in this population, but these events are not the major cause of morbidity and mortality in patients with recent worsening of HF for which rivaroxaban had no effect,” the authors concluded. “While consistent with other studies, these results require confirmation in prospective randomized clinical trials.”

In an accompanying editorial comment, Marvin Konstam, MD, of the CardioVascular Center at Tufts Medical Center in Boston, noted that the findings of COMMANDER-HF were as expected.

“The findings are not unexpected, since the rates of the parent trial’s primary end point components of MI and stroke were numerically reduced by rivaroxaban,” he wrote. “The authors appropriately conclude that these findings are hypothesis-generating but that they support continued examination of the role of antithrombotic treatment in patients with HF.”