Peripheral artery disease (PAD) is a circulatory condition characterized by narrow arteries, resulting in reduced blood flow to the limbs. Patients who have undergone revascularization are at higher risk of PAD. Rivaroxaban is an anticoagulant medication routinely used for treating PAD. This study aims to analyze the safety and efficacy of rivaroxaban for the treatment of PAD after revascularization.


This double-blind trial included a total of 6,564 patients with PAD who had undergone revascularization. The patients were randomly assigned in a 1:1 ratio to receive rivaroxaban (2.5 mg twice daily) plus aspirin (n=3,286) or placebo plus aspirin (n=3,278). The primary outcome of the study was a composite of myocardial infarction, ischemic stroke, limb ischemia, or death from cardiovascular causes. Safety outcomes, primary major bleeding, were also considered.

Of 3,286 patients in the rivaroxaban group, the primary outcome occurred in 508 patients, as compared with 584 patients in the placebo group. The incidence rate of cardiovascular events, as calculated by the Kaplan–Meier estimates, was 17.3% in the rivaroxaban group and 19.9% in the placebo group. Major bleeding occurred in 62 patients in the rivaroxaban group, as compared with 44 patients in the placebo group.

The research concluded that rivaroxaban with aspirin was associated with a significantly lower incidence of cardiovascular outcomes when compared with aspirin alone.