ARIXTRA for VTE prophylaxis after major orthopedic surgery
ARIXTRA significantly reduced the rate of venous thromboembolism (VTE) by 55% compared to enoxaparin [4]
A meta-analysis of 4 randomized, double-blind clinical trials involving patients undergoing elective hip replacement, total hip replacement, elective major knee, or hip fracture surgery was performed to compare the efficacy and safety of once-daily ARIXTRA 2.5 mg in the prevention of DVT or PE following major orthopedic surgery. The primary efficacy endpoint in these studies was the presence of VTE including DVT, PE, or both, up to Day 11 following surgery. These 4 studies were planned with the purpose of subsequently performing a meta-analysis of the data. [4]
ARIXTRA provided significant VTE risk reduction in all orthopedic surgery studies
ARIXTRA significantly reduced the risk of VTE vs enoxaparin in all orthopedic surgery studies with a risk reduction of:
- 56% in hip fracture (52/626 for ARIXTRA vs 119/624 for enoxaparin, P<0.001) [5]
- 55% in knee replacement(45/361 for ARIXTRA vs 101/363 for enoxaparin, P<0.001) [6]
- 56% in hip replacement (37/908 for ARIXTRA vs 85/919 for enoxaparin, P<0.0001) [7]
- In a fourth clinical study, ARIXTRA reduced VTE by 26% (48/787 for ARIXTRA vs 66/797 for enoxaparin, P=NS) following hip replacement surgery [8]
No difference in clinically relevant bleeding compared with enoxaparin. [5]
Clinically relevant bleeding was defined by the study authors to be fatal bleeding, bleeding in a critical organ, or bleeding leading to another operation.
- In a separate analysis, the incidence of major bleeding when ARIXTRA was dosed <4 hours after surgery was 4.8% (5/104) and 2.3% (28/1,196) when ARIXTRA was dosed 4-6 hours after surgery. However, when ARIXTRA was dosed 6-8 hours after surgery, the incidence of bleeding was 1.9% (38/1,965).
Select a link below to learn more about the studies in the meta-analysis:
Hip fracture surgery
Knee replacement surgery
Hip replacement surgery