Apixaban versus enoxaparin for thromboprophylaxis after hip or knee replacement:
pooled analysis of major venous thromboembolism and bleeding in 8464 patients
from the ADVANCE-2 and ADVANCE-3 trials.
Author(s): Raskob GE, Gallus AS, Pineo GF, Chen D, Ramirez LM, Wright RT, Lassen MR.
Affiliation(s): University of Oklahoma Health Sciences Center, College of Public Health, 801 NE
13th Street, Oklahoma City, Oklahoma 73104, USA. gary-raskob@ouhsc.edu
Publication date & source: 2012, J Bone Joint Surg Br. , 94(2):257-64
In order to compare the effect of oral apixaban (a factor Xa inhibitor) with
subcutaneous enoxaparin on major venous thromboembolism and major and non-major
clinically relevant bleeding after total knee and hip replacement, we conducted a
pooled analysis of two previously reported double-blind randomised studies
involving 8464 patients. One group received apixaban 2.5 mg twice daily (plus
placebo injection) starting 12 to 24 hours after operation, and the other
received enoxaparin subcutaneously once daily (and placebo tablets) starting 12
hours (± 3) pre-operatively. Each regimen was continued for 12 days (± 2) after
knee and 35 days (± 3) after hip arthroplasty. All outcomes were centrally
adjudicated. Major venous thromboembolism occurred in 23 of 3394 (0.7%) evaluable
apixaban patients and in 51 of 3394 (1.5%) evaluable enoxaparin patients (risk
difference, apixaban minus enoxaparin, -0.8% (95% confidence interval (CI) -1.2
to -0.3); two-sided p = 0.001 for superiority). Major bleeding occurred in 31 of
4174 (0.7%) apixaban patients and 32 of 4167 (0.8%) enoxaparin patients (risk
difference -0.02% (95% CI -0.4 to 0.4)). Combined major and clinically relevant
non-major bleeding occurred in 182 (4.4%) apixaban patients and 206 (4.9%)
enoxaparin patients (risk difference -0.6% (95% CI -1.5 to 0.3)). Apixaban 2.5 mg
twice daily is more effective than enoxaparin 40 mg once daily without increased
bleeding.
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