COMPASS²

COMPASS trial design: A phase 3, multicenter, double-dummy, event-driven study of patients with a stable atherosclerotic vascular disease. Using a 1:1:1 randomization, patients received XARELTO^® 2.5 mg twice daily plus aspirin 100 mg once daily (n=9152), rivaroxaban 5 mg twice daily (n=9117), or aspirin 100 mg once daily (n=9126).

Because the rivaroxaban 5 mg dose alone was not superior to aspirin alone, only the data concerning the XARELTO^® 2.5 mg dose plus aspirin are discussed.

COMPASS primary outcomes were a composite of cardiovascular death, stroke, and myocardial infarction. The principal safety outcome was a modification of the ISTH criteria for major bleeding and included fatal bleeding, symptomatic bleeding into a critical organ, bleeding into a surgical site requiring reoperation, and bleeding that led to hospitalization with or without an overnight stay.

*Patients with coronary syndromes (CAD) and in sinus rhythm.

^†The specific lipid-lowering medication was not recorded at baseline.

ACE = angiotensin-converting enzyme; ARB = angiotensin II receptor blocker; CAD = coronary artery disease; DOAC = direct oral anticoagulant; ESC = European Society of Cardiology; ISTH = International Society on Thrombosis and Haemostasis; MI = myocardial infarction; NSAID = nonsteroidal anti-inflammatory drug; PAD = peripheral artery disease; PPI = proton pump inhibitor.