Home > Journal Club > Journal Club 11 November 2015

Journal Club 11 November 2015

Paper

Apixaban for Extended Treatment of Venous Thromboembolism

Presenter

SP

Summary

Background

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.

Methods

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.

Results

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.

Conclusions

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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