Home > Journal Club > Journal Club 11 November 2015

Journal Club 11 November 2015


Apixaban for Extended Treatment of Venous Thromboembolism





Apixaban, an oral factor Xa inhibitor that can be administered in a simple, fixed-dose
regimen, may be an option for the extended treatment of venous thromboembolism.


In this randomized, double-blind study, we compared two doses of apixaban (2.5 mg
and 5 mg, twice daily) with placebo in patients with venous thromboembolism who
had completed 6 to 12 months of anticoagulation therapy and for whom there was
clinical equipoise regarding the continuation or cessation of anticoagulation therapy.
The study drugs were administered for 12 months.


A total of 2486 patients underwent randomization, of whom 2482 were included in
the intention-to-treat analyses. Symptomatic recurrent venous thromboembolism
or death from venous thromboembolism occurred in 73 of the 829 patients (8.8%)
who were receiving placebo, as compared with 14 of the 840 patients (1.7%) who
were receiving 2.5 mg of apixaban (a difference of 7.2 percentage points; 95% confidence
interval [CI], 5.0 to 9.3) and 14 of the 813 patients (1.7%) who were receiving
5 mg of apixaban (a difference of 7.0 percentage points; 95% CI, 4.9 to 9.1)
(P<0.001 for both comparisons). The rates of major bleeding were 0.5% in the placebo
group, 0.2% in the 2.5-mg apixaban group, and 0.1% in the 5-mg apixaban
group. The rates of clinically relevant nonmajor bleeding were 2.3% in the placebo
group, 3.0% in the 2.5-mg apixaban group, and 4.2% in the 5-mg apixaban group.
The rate of death from any cause was 1.7% in the placebo group, as compared with
0.8% in the 2.5-mg apixaban group and 0.5% in the 5-mg apixaban group.


Extended anticoagulation with apixaban at either a treatment dose (5 mg) or a
thromboprophylactic dose (2.5 mg) reduced the risk of recurrent venous thromboembolism
without increasing the rate of major bleeding.

Supplementary Material

ESC Venous Thromboembolism Guidelines

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