XARELTO®: COMPASS clinical trial in chronic CAD/PAD

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 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 twice daily (n=9126).

Because the 5 mg dose alone was not superior to aspirin alone, only the data concerning the 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.

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


ACE = angiotensin-converting-enzyme; ARB = angiotension II receptor blockers; CAD = coronary artery disease; CV = cardiovascular; ISTH = International Society on Thrombosis and Haemostasis; MI = myocardial infarction; NSAID = nonsteroidal anti-inflammatory drug; PAD = peripheral artery disease; PPI = proton pump inhibitor.