XARELTO^®: Safety profile in coronary artery disease (CAD) and/or peripheral artery disease (PAD)

PROVEN SAFETY PROFILE¹

CAD AND/OR PAD

XARELTO^® vascular dose* (2.5 mg BID with aspirin 100 mg QD)	Placebo + aspirin (100 mg QD)
Event rate (%/year [n/N])
Major bleeding^† HR (95% CI): 1.8 (1.5, 2.3)
1.6%(263/9134)	0.9%(144/9107)
Fatal bleeding event HR (95% CI): 1.5 (0.6, 3.7)
<0.1%(12/9134)	<0.1%(8/9107)
Symptomatic bleeding in critical organ (nonfatal) HR (95% CI): 1.4 (0.9, 2.0)
0.3% (58/9134)	0.3%(43/9107)
Bleeding into surgical site requiring reoperation (nonfatal, not in critical organ) HR (95% CI): 1.2 (0.4, 3.5)
<0.1%(7/9134)	<0.1%(6/9107)
Bleeding leading to hospitalization (nonfatal, not in critical organ, not requiring reoperation) HR (95% CI): 2.1 (1.6, 2.7)
1.1%(188/9134)	0.5%(91/9107)

Major bleeding was increased; however, ~97% of patients taking the XARELTO^® vascular dose* did not experience major bleeding¹

≤1% OF PATIENTS HAD FATAL BLEEDING, NONFATAL ICH, OR CRITICAL ORGAN BLEEDING²

STUDY DESIGN

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.

*XARELTO^® 2.5 mg twice daily plus aspirin 100 mg once daily.
^†Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. These events occurred during treatment or within 2 days of stopping treatment in the safety analysis set.

ICH = intracranial hemorrhage; ISTH = International Society on Thrombosis and Haemostasis.

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