January 1, 2003Thrombosis and Haemostasis
Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement
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Why the study?
Does melagatran followed by oral ximelagatran prevent venous thromboembolism compared to enoxaparin in patients undergoing total hip or knee replacement?
Population
2788 patients undergoing total hip or knee replacement
Comparison
Subcutaneous melagatran 3 mg started 4-12 h… vs Subcutaneous enoxaparin 40 mg once-daily…
Design
RCT, randomly assigned, double-blind
Follow-up
8 to 11 days
Authors
Discussion
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Implication
Ximelagatran is not noninferior to enoxaparin for VTE prevention after major orthopedic surgery; challenges its adoption as an oral alternative.
Structured PICO
Does melagatran followed by oral ximelagatran prevent venous thromboembolism compared to enoxaparin in patients undergoing total hip or knee replacement?
P
Population
2788 patients undergoing total hip or knee replacement
I
Intervention
Subcutaneous melagatran 3 mg started 4-12 h postoperatively, followed by oral ximelagatran 24 mg twice-daily for 8 to 11 days
C
Comparator
Subcutaneous enoxaparin 40 mg once-daily, started 12 h preoperatively for 8 to 11 days
O
Outcome
Venous thromboembolism (deep-vein thrombosis detected by mandatory venography, pulmonary embolism or unexplained death)composite
Postoperative melagatran followed by oral ximelagatran resulted in a marginally higher rate of venous thromboembolism compared to preoperative enoxaparin after major orthopedic surgery, with comparable bleeding.
Cite This Study
Agnelli et al. (2003) studied this question.
Topics
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