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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

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
Issue: 2003: 89/2 (Feb) pp.206-408
Pages: 288-296

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

Bengt I. Eriksson (1), Giancarlo Agnelli (2), Alexander T. Cohen (3), Ola E. Dahl (4), Patrick Mouret (5), Nadia Rosencher (6), Christina Eskilson (7), Ingela Nylander (7), Lars Frison (7), Mats Ögren (7), on behalf of the METHRO III Study Group* (* see
(1) Department of Orthopaedics, Sahlgrenska University Hospital/Östra, Göteborg, Sweden, (2) Division of Internal and Cardiovascular Medicine, University of Perugia, Perugia, Italy, (3) Department of Academic Surgery, Guy’s, King’s,Thomas’ School of Medi

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.