A Study of Flexible Dosage in Extended PE PE
Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
/DVT DVT
Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
Treatment

EINSTEIN CHOICE: A Study of Xarelto® with a Flexible Choice of Dosage for Extended Treatment of Recurrent VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.

Objective

  • To compare the efficacy and safety profile of 20 mg OD or 10 mg OD Xarelto doses with aspirin for extended treatment of recurrent VTE, in patients who had been treated for 6–12 months with an anticoagulant anticoagulant
    Anticoagulant drugs are used to treat and prevent blood clots. Sometimes referred to as ‘blood thinners’.
    therapy1

Study Design

  • EINSTEIN CHOICE is a randomised, double-blind, active-controlled, event-driven, superiority, phase III study1
  • The primary efficacy outcome was symptomatic, recurrent, fatal or non-fatal VTE, and the principal safety outcome was major bleeding1
EINSTEIN CHOICE study design

a≤7 days of treatment interruption prior to randomisation. bPatients randomised after the requisite number of primary efficacy outcomes was reached were treated for ≥6 months.

Patients’ Clinical Characteristics

EINSTEIN CHOICE table

Key Findings

  • Efficacy
    • Both 10 mg OD and 20 mg OD Xarelto doses significantly reduce the risk of recurrent VTE vs aspirinc,1
  • Safety
    • Both 10 mg OD and 20 mg OD Xarelto doses demonstrated a low risk of major bleeding, similar to aspirinc,1
    • Overall rates of major and clinically relevant non-major bleeding were similar between both Xarelto doses and aspirinc,1

VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
, venous thromboembolism; OD, once daily; PE PE
Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
, pulmonary embolism; DVT DVT
Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
, deep vein thrombosis thrombosis
Formation of a clot inside a blood vessel.
.
cFor VTE extended treatment.