COMPASS INCLUDED PATIENTS WITH A VARIETY OF RISK FACTORS AND ON MEDICATIONS CONSISTENT WITH GUIDELINE RECOMMENDATIONS2,4,5
| BASELINE CHARACTERISTICS | Rivaroxaban plus aspirin N=9152 (%) |
|---|---|
| Hypertension | 6907 (76) |
| Previous MI | 5654 (62) |
| Diabetes | 3448 (38) |
| Heart failure | 1963 (21) |
| Tobacco use | 1944 (21) |
| CONCOMITANT MEDICATIONS | Rivaroxaban plus aspirin N=9152 (%) |
|---|---|
| Lipid-lowering agent† | 8239 (90) |
| ACE inhibitor/ARB | 6475 (71) |
| Beta blocker | 6389 (70) |
| Nontrial PPI | 3268 (36) |
| Diuretic | 2727 (30) |
| Calcium-channel blocker | 2413 (26) |
| NSAID | 531 (6) |
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.
