A phase 3 trial evaluating the efficacy and safety of rivaroxaban (Xarelto, Bayer/Janssen), an oral anticoagulant, for the prevention of major adverse cardiac events (MACE)––including cardiovascular death, myocardial infarction, and stroke––in patients with coronary artery disease (CAD) or peripheral artery disease (PAD) has met its primary endpoint. The study’s independent data monitoring committee recommended that the trial be stopped early as the primary MACE endpoint had reached its prespecified criteria for superiority.
The COMPASS trial enrolled 27,402 patients in more than 30 countries worldwide. The patients were randomly assigned to receive either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once daily; rivaroxaban 5.0 mg twice daily alone; or aspirin 100 mg once daily alone.
CAD is the most common cause of cardiovascular disease and is responsible for approximately 7.3 million deaths worldwide each year. One-third to one-half of all middle-aged men and women in high-income countries are at risk of developing CAD during their lifetimes. By 2020, the burden of CAD is projected to reach 82 million disability-adjusted life years (DALYs) or “healthy years of life lost.”
PAD, while often undiagnosed, affects more than 27 million people in North America and Europe and is an important risk marker of cardiovascular disease. Globally, screening studies have suggested that approximately 20% of adults older than 55 years of age have evidence of PAD. The disease prevalence is strongly age-related, and the number of affected patients is rising because of the aging of the population.
In the United States, rivaroxaban has the following indications: