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

Safety image for major bleeding in EINSTEIN CHOICE

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

Chart displaying major bleeding versus aspirin in patients with PE index event


Trial design: A randomized, phase 3, double-blind, active-comparator, event-driven, superiority study comparing the efficacy and safety of once-daily XARELTO® at doses of 20 mg or 10 mg versus 100 mg of aspirin in patients with VTE who completed 6 to 12 months of treatment with VKA or a DOAC and were in equipoise regarding the need for extended anticoagulation. Study drugs were administered up to 12 months.

Because the benefit-risk assessment favored once-daily XARELTO® at the 10-mg dose versus aspirin (100 mg) compared with XARELTO® 20 mg once daily versus aspirin, the XARELTO® 10-mg dose is approved to reduce the risk of recurrent DVT/PE.

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; PE = pulmonary embolism; VKA = vitamin K antagonist.

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