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Major Trials with Major Impact: Compass Trial

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Dr Pankaj Jariwala, Hyderabad    04 January 2018

  1. No significant benefit of rivaroxaban alone.
  2. 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

  1. Exclusion of 2,320 participants after run-in period (due to failure to adhere/tolerate) raises possibility of selection bias and decreased generalizability.
  2. 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.
  3. The lack of statistical significance of the observed trend towards improved mortality with combination rivaroxaban + aspirin may be due to underpowering for this outcome.

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