XARELTO®: Efficacy profile in extended treatment and reduction in the risk of recurrence in deep vein thrombosis (DVT) and pulmonary embolism (PE)


Chevron detailing efficacy in extended treatment

1.2% (13/1127) with XARELTO® versus 4.4% (50/1131) with aspirin

*After ≥6 months initial treatment.

Consistent reduction in DVT/PE in patients with an index PE event and in patients with a BMI ≥30 kg/m2 1,2

Lower rates of recurrent DVT/PE in patients with a PE index event

Chart showing consitent DVT/PE reduction in patients with PE index

Nearly 50% of patients had a PE as
the index event in EINSTEIN CHOICE1

Lower rates of DVT/PE in patients with a BMI ≥30 kg/m2

Chart showing consitent DVT/PE reduction in patients with BMI ≥30 kg/m2

Safety was not reported in patients with BMI ≥30 kg/m2.

For VTE prophylaxis in acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.


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.

RRR calculated using 1 minus HR.

The decision regarding initiation setting should be based on the prescriber's clinical judgment.

BMI = body mass index; DOAC = direct oral anticoagulant; DVT = deep vein thrombosis; HR = hazard ratio; PE = pulmonary embolism; RRR = relative risk reduction; VKA = vitamin K antagonist; VTE = venous thromboembolism.