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

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.