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

SUPERIOR REDUCTION IN THE RISK OF RECURRENT DVT/PE*1

DVT PE EfficacyDVT PE Efficacy

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 BMI ≥30 kg/m2 1,2

Rates of recurrent DVT/PE in patients with a PE index event

Chart consistent DVT/PE reduction in patients with PE indexChart consistent DVT/PE reduction in patients with PE index

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

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

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

Chart consistent DVT/PE reduction in patients with BMI ≥30 kg/m2Chart consistent DVT/PE reduction in patients with BMI ≥30 kg/m2

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

EINSTEIN CHOICE1,2

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.

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

Previous: DVT/PE Clinical Trials

Next: DVT/PE Safety Profile

References: 1. Weitz JI, Lensing AWA, Prins MH, et al; for the EINSTEIN CHOICE Investigators. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med. 2017;376(13):1211-1222. 2. Supplement to: Weitz JI, Lensing AWA, Prins MH, et al; for the EINSTEIN CHOICE Investigators. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med. 2017;376(13):1211-1222. 3. The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-1297. 4. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510. 5. Eriksson BI, Borris LC, Friedman RJ, et al; for the RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775. 6. Kakkar AK, Brenner B, Dahl OE, et al; for the RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39. 7. Lassen MR, Ageno W, Borris LC, et al; for the RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786. 8. Cohen AT, Spiro TE, Büller HR, et al; for the MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013;368(6):513-523.