XARELTO®: Safety profile in chronic CAD/PAD

PROVEN SAFETY PROFILE

CHRONIC CAD/PAD

 
XARELTO®
(2.5 mg twice daily with aspirin 100 mg once daily)
Aspirin
(100 mg once daily)
Event rate (%)
Modified ISTH major bleeding
HR (95% CI): 1.84(1.50-2.26)
2.9%(263/9134) 1.6%(144/9107)
Fatal bleeding
HR (95% CI): 1.51(0.62-3.69)
0.1%(12/9134) 0.1%(8/9107)
Critical organ bleeding (nonfatal)
HR (95% CI): 1.36(0.91-2.01)
0.6% (58/9134) 0.5%(43/9107)
Bleeding into surgical site
HR (95% CI): 1.17(0.39-3.48)
0.1%(7/9134) 0.1%(6/9107)
Bleeding leading to hospitalization
HR (95% CI): 2.08(1.62-2.67)
2.1%(188/9134) 1.0%(91/9107)
 

Consistent safety profile in chronic PAD subgroup1

CHRONIC PAD SUBGROUP

 
XARELTO®
(2.5 mg twice daily with aspirin 100 mg once daily)
Aspirin
(100 mg once daily)
Event rate (%)
Major bleeding
HR (95% CI): 1.61 (1.12-2.31)
3%(77/2492) 2%(48/2504)
GI bleeding
HR (95% CI): 2.28 (1.31-3.96)
2%(41/2492) 1%(18/2504)
Fatal bleeding
N/A
<1%(4/2492) <1%(3/2504)
Nonfatal ICH
N/A
<1%(4/2492) <1%(8/2504)
Critical organ bleed (nonfatal, non-ICH)
HR (95% CI): 1.55 (0.64-3.74)
1%(13/2492) <1%(8/2504)

≤1% OF PATIENTS HAD FATAL BLEEDING, NONFATAL ICH, OR CRITICAL ORGAN BLEEDING1

COMPASS1

COMPASS trial design: A phase 3, multicenter, double-dummy study of patients with a history of stable atherosclerotic vascular disease (no NVAF diagnosis). Using a 1:1:1 randomization, patients received XARELTO® 2.5 mg twice daily plus aspirin 100 mg once daily (n=9152), XARELTO® 5 mg twice daily (n=9117), or aspirin 100 mg twice daily (n=9126). 

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.

CAD = coronary artery disease; GI = gastrointestinal; HR = hazard ratio; ICH = intracranial hemorrhage; ISTH = International Society on Thrombosis and Haemostasis; MI = myocardial infarction; PAD = peripheral artery disease.