Rivaroxaban in Combination with Aspirin Now FDA Approved for Chronic Artery Disease

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Rivaroxoban is a factor Xa inhibitor used for treating and preventing venous thromboemblism as well as preventing strokes in individuals with atrial fibrillation.   Rivaroxoban 2.5 mg twice a day in combination with aspirin was recently approved by the FDA for reducing the risk of major cardiovascular (CV) events, like death, myocardial infarction (MI), and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD).  The approval is based on the COMPASS Trial trial, a randomized, double-blind, placebo controlled, phase 3 clinical trial.   This study randomized 7470 patients with CAD or PAD to rivaraxoban 2.5 mg twice a day with aspirin 100 mg once a day, rivaraxoban 5 mg twice a day alone or aspirin alone. Patients randomized to rivaroxaban and aspirin had significantly fewer CV events when compared to aspirin alone.  Rivaroxaban alone was not significantly better than aspirin alone.   The risk of major bleeding was significantly higher in patients taking the rivaroxaban alone or in combination aspirin, compared to aspirin alone, but with no significant increase in fatal or intracranial bleeds. 


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Jill Kolesar & Lee Vermeulen

Professors, University of Kentucky

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