Journal article
Apixaban versus Enoxaparin for Thromboprophylaxis after Hip Replacement
New England Journal of Medicine, Vol.363(26), pp.2487-2498
2010
Abstract
BACKGROUND
There are various regimens for thromboprophylaxis after hip replacement. Low-molecular-weight heparins such as enoxaparin predominantly inhibit factor Xa but also inhibit thrombin to some degree. Orally active, specific factor Xa inhibitors such as apixaban may provide effective thromboprophylaxis with a lower risk of bleeding and improved ease of use.
METHODS
In this double-blind, double-dummy study, we randomly assigned 5407 patients undergoing total hip replacement to receive apixaban at a dose of 2.5 mg orally twice daily or enoxaparin at a dose of 40 mg subcutaneously every 24 hours. Apixaban therapy was initiated 12 to 24 hours after closure of the surgical wound; enoxaparin therapy was initiated 12 hours before surgery. Prophylaxis was continued for 35 days after surgery, followed by bilateral venographic studies. The primary efficacy outcome was the composite of asymptomatic or symptomatic deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause during the treatment period. Patients were followed for an additional 60 days after the last intended dose of study medication.
RESULTS
A total of 1949 patients in the apixaban group (72.0%) and 1917 patients in the enoxaparin group (71.0%) could be evaluated for the primary efficacy analysis. The primary efficacy outcome occurred in 27 patients in the apixaban group (1.4%) and in 74 patients in the enoxaparin group (3.9%) (relative risk with apixaban, 0.36; 95% confidence interval [CI], 0.22 to 0.54; P<0.001 for both noninferiority and superiority; absolute risk reduction, 2.5 percentage points; 95% CI, 1.5 to 3.5). The composite outcome of major and clinically relevant nonmajor bleeding occurred in 129 of 2673 patients assigned to apixaban (4.8%) and 134 of 2659 assigned to enoxaparin (5.0%) (absolute difference in risk, −0.2 percentage points; 95% CI, −1.4 to 1.0).
CONCLUSIONS
Among patients undergoing hip replacement, thromboprophylaxis with apixaban, as compared with enoxaparin, was associated with lower rates of venous thromboembolism, without increased bleeding.
Details
- Title
- Apixaban versus Enoxaparin for Thromboprophylaxis after Hip Replacement
- Authors/Creators
- M.R. Lassen (Author/Creator)A. Gallus (Author/Creator)G.E. Raskob (Author/Creator)G. Pineo (Author/Creator)D. Chen (Author/Creator)L.M. Ramirez (Author/Creator)R.I. Baker (Author/Creator)
- Publication Details
- New England Journal of Medicine, Vol.363(26), pp.2487-2498
- Publisher
- Massachusetts Medical Society
- Identifiers
- 991005540586007891
- Copyright
- © 2017 Massachusetts Medical Society
- Murdoch Affiliation
- Institute for Immunology and Infectious Diseases
- Language
- English
- Resource Type
- Journal article
- Additional Information
- Murdoch University authors made contribution to this work as part of the ADVANCE-3 Investigators
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