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Rivaroxaban Benefit in CAD, PAD Stops Huge Randomized Trial

A daily antithrombotic regimen containing rivaroxaban (Xarelto, Bayer/Janssen) fared significantly better than aspirin alone for the primary end point in a massive randomized clinical-outcomes trial of patients with CAD or peripheral artery disease (PAD), according to company announcements.

The phase 3 Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial was halted more than a year ahead of its planned March 2018 completion because, in an interim analysis, the primary end point of MI, stroke, or cardiovascular death "has reached its prespecified criteria for superiority." In their press releases with superficial top-line COMPASS results, the companies did not discuss the other primary end point of major bleeding.

The trial had randomized 27,402 patients at hundreds of sites around the world to receive the direct oral anticoagulant (DOAC) rivaroxaban at 2.5 mg twice daily plus aspirin at 100 mg/day, or rivaroxaban 5 mg twice daily without aspirin, or aspirin 100 mg/day without rivaroxaban.

The companies do not say which rivaroxaban-containing regimen was superior for the primary end point. Dr Stuart J Connolly (McMaster University, Hamilton, ON) would tell heartwire from Medscape only "that at least one of the rivaroxaban-based arms was superior to aspirin alone." Connolly is on the executive committee of his center"s Population Health Research Institute (PHRI), which played a lead role in the trial.