XARELTO®: Safety profile in extended treatment and reduction in the risk of recurrence in deep vein thrombosis (DVT) and pulmonary embolism (PE)
The only DOAC to demonstrate a major bleeding rate as low as aspirin in DVT/PE*1
Similar rates of major bleeding
0.4% with XARELTO® versus 0.3% with aspirin
<1% major bleeding rates
*After ≥6 months initial treatment.
†Major bleeding for XARELTO® was 0.4% (5/1127) versus 0.3% (3/1131) for aspirin and was defined as overt bleeding that was associated with a decrease in the hemoglobin level of ≥2 g/dL, led to transfusion of ≥2 units of red cells, occurred in a critical site, or contributed to death.
Similar rates of major bleeding in patients with a PE index event2
◇For VTE prophylaxis in acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.
Primary outcomes: The primary efficacy outcome was symptomatic recurrent fatal or nonfatal VTE and the principal safety outcome was major bleeding.
‡The decision regarding initiation setting should be based on the prescriber's clinical judgment.
DOAC = direct oral anticoagulant; DVT = deep vein thrombosis; HR = hazard ratio; PE = pulmonary embolism; VKA = vitamin K antagonist; VTE = venous thromboembolism.