Rivaroxaban, Aspirin, or Both in Stable Coronary Disease

Aspirin remains the mainstay of secondary prevention for coronary artery disease; vitamin K antagonists are superior when added to aspirin or used alone for patients with acute myocardial infarction (MI), but excess bleeding has limited their use. In the manufacturer-sponsored, double-blind COMPASS trial, investigators enrolled 27,395 patients (mean age, 68; 22% women) with stable coronary artery disease to the direct-acting oral anticoagulant rivaroxaban (2.5 mg twice a day) plus aspirin (100 mg daily), rivaroxaban (5 mg twice a day), or aspirin (100 mg daily). The primary outcome was cardiovascular death, stroke, or MI.

The study was stopped after 23 months of follow-up because of a significant advantage in efficacy for rivaroxaban plus aspirin. The primary outcome occurred in 4.1% of patients who received rivaroxaban plus aspirin, 4.9% who received rivaroxaban alone, and 5.4% who received aspirin alone. When bleeding events (3.1%, 2.8%, and 1.9%, respectively) were included in the analysis, the net clinical benefit remained significantly greater with rivaroxaban plus aspirin than with aspirin alone; rivaroxaban alone did not have a significant advantage over aspirin alone. Results were consistent across predefined subgroups including age, sex, geographic region, and race or ethnicity.