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DOI: 10.1055/s-0037-1613445
Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement
The METHRO III study Financial support: This study was supported by a research grant from AstraZeneca, Mölndal, Sweden. AstraZeneca sponsored METHRO III and provided all study medication and materials.Publication History
Received
28 August 2002
Accepted after revision
27 November 2002
Publication Date:
07 December 2017 (online)
![](https://www.thieme-connect.de/media/10.1055-s-00035024/200302/lookinside/thumbnails/10-1055-s-0037-1613445-1.jpg)
Summary
We evaluated whether a postoperative regimen with melagatran followed by oral ximelagatran, two new direct thrombin inhibitors, was an optimal regimen for thromboprophylaxis in major orthopaedic surgery. In a double-blind study, 2788 patients undergoing total hip or knee replacement were randomly assigned to receive for 8 to 11 days either 3 mg of subcutaneous melagatran started 4-12 h postoperatively, followed by 24 mg of oral ximelagatran twice-daily or 40 mg of subcutaneous enoxaparin once-daily, started 12 h preoperatively. Ximelagatran was to be initiated within the first two postoperative days. The primary efficacy endpoint was venous thromboembolism (deep-vein thrombosis detected by mandatory venography, pulmonary embolism or unexplained death). The main safety endpoint was bleeding. Venous thromboembolism occurred in 355/1146 (31.0%) and 306/1122 (27.3%) patients in the ximelagatran and enoxaparin group, respectively, a difference in risk of 3.7% in favour of enoxaparin (p = 0.053). Bleeding was comparable between the two groups.
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