UPDATED October 15, 2018 // The US Food and Drug Administration (FDA) has approved rivaroxaban (Xarelto, Janssen) in combination with aspirin to reduce the risk for major cardiovascular (CV) events in adults with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). Rivaroxaban is the first and only non–vitamin K antagonist oral anticoagulant with this indication, the company said in a news release. The European Commission approved a regimen of rivaroxaban plus aspirin for CAD and PAD in August, as reported by the heart.org | Medscape Cardiology. The approval is based on data from the phase 3 COMPASS study, which showed that rivaroxaban 2.5 mg twice daily plus acetylsalicylic acid (ASA) 100 mg once daily was associated with a 24% reduced risk for the composite of stroke, cardiovascular death, and myocardial infarction, compared with ASA 100 mg once daily alone in patients with CAD or PAD. There was a 42% reduction in stroke, a 22% reduction in CV death, and a 14% reduction in myocardial infarction. The risk of major bleeding was significantly higher with rivaroxaban plus aspirin than with aspirin alone, but there was no significant increase in fatal or intracranial bleeds. The COMPASS results were presented at the European Society of Cardiology (ESC) 2017 Congress by John Eikelboom, MD, McMaster University, Hamilton, Canada, simultaneously published online in the New England Journal of Medicine, and reported by theheart.org | Medscape Cardiology. "Treating patients with aspirin only is simply not enough to address the underlying thrombotic risk that comes with chronic CAD and PAD. As we saw in the COMPASS trial, the dual pathway approach of aspirin and the 2.5-mg, twice-daily dose of Xarelto can help significantly reduce the risk of CV events in these populations," Kelley Branch, MD, associate professor in cardiology, University of Washington, Seattle, said in the news release. Rivaroxaban has had some recent setbacks with results of the COMMANDER HF trial, presented at the European Society of Cardiology Congress 2018, which showed that long-term oral anticoagulation with rivaroxaban had no apparent effect on the risk for death, MI, or stroke in patients with a recent episode of worsening heart failure, and the early termination this week of the GALILEO trial, after preliminary analysis showed that treatment with rivaroxaban was associated with an increase in all-cause death, thromboembolic events, and bleeding when given after successful transcatheter aortic valve replacement. Source
