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Rapid fire session: Major trials with major impact COMPASS trial

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Dr Pankaj Jariwala, Hyderabad    01 December 2017

Rivaroxaban 2.5 mg bid aspirin 100 mg od Reduces CV death stroke MI increases major bleeding without a significant increase in fatal intracranial or critical organ bleeding and provides a net clinical benefit. No significant benefit of Rivaroxaban alone. In patients with established stable atherosclerotic disease rivaroxaban aspirin resulted in a modest 1.3 absolute risk reduction in CV death stroke or nonfatal MI with a trend toward improved mortality. This benefit was offset by a 1.2 increased absolute risk in major bleeding. Criticism Exclusion of 2320 participants after run in period due to failure to adhere tolerate raises possibility of selection bias and decreased generalizability Study terminated early due to efficacy of rivaroxaban aspirin vs aspirin alone. Thus the study may overestimate the degree of benefit of rivaroxaban aspirin and potentially underestimate the degree of increased bleeding with this therapy. The lack of statistical significance of the observed trend towards improved mortality with combination rivaroxaban plus aspirin may be due to underpowering for this outcome.

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