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

The EINSTEIN CHOICE trial studied extended treatment in patients with DVT/PE1

 
Characteristic

XARELTO®

10 mg

(N=1127)

Aspirin

100 mg

(N=1131)

Age—year
Mean ± SD 58.8±14.7 58.8±14.7
Body mass index
<30 66.6% 66.8%
≥30 33.4% 33.2%
Index event
Isolated DVT 50.1% 51.0%
Isolated PE 33.8% 32.4%
Both DVT and PE 15.9% 16.0%
Index event asymptomatic or unconfirmed 0.2% 0.6%

 

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

EINSTEIN CHOICE1,8

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; VTE = venous thromboembolism.