Five to 10% of patients with cardiovascular disease have recurrent events each year. Despite evidence in support of adding warfarin to antiplatelet agents for secondary prevention among at-risk patients, the countervailing bleeding risks have limited adoption in clinical practice. Given the potentially favorable risk profile of direct oral anticoagulants compared to warfarin, these agents have generated interest as potential adjunctive therapy for secondary cardiovascular prevention.<\/p>\n
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The Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial randomized 27,395 patients with stable cardiovascular disease to receive either rivaroxaban 2.5 mg twice daily plus aspirin, rivaroxaban 5 mg twice daily alone, or aspirin alone in double blind fashion in addition to standard medical therapy.\u00a0 The primary outcome was a composite of cardiovascular death, stroke or myocardial infarction.\u00a0 The trial was stopped at 23 months due to superiority of rivaroxaban plus aspirin, which was associated with a significant decrease in the primary outcome (4.1 vs 5.4%, p<0.001) and an 0.7% absolute decrease in all-cause mortality (p = NS), though was also associated with more major bleeding (3.1 vs 1.9%, p<0.001) when compared to aspirin alone.\u00a0 There was no significant difference in fatal bleeding or intracranial hemorrhage between these two groups. Compared to aspirin alone, rivaroxaban alone did not significantly decrease thrombotic events but resulted in increased major bleeding (2.8 vs 1.9%, p<0.001).<\/p>\n