Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement

Bengt I. Eriksson; Giancarlo Agnelli; Alexander T. Cohen; Ola E. Dahl; Patrick Mouret; Nadia Rosencher; Christina Eskilson; Ingela Nylander; Lars Frison; Mats ögren; on behalf of the METHRO III Study Group* (* see Appendix for METHRO III study participants)

doi:10.1055/s-0037-1613445

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2003; 89(02): 288-296
DOI: 10.1055/s-0037-1613445

Blood Coagulation, Fibrinolysis and Cellular Haemostasis

Schattauer GmbH

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

¹Department of Orthopaedics, Sahlgrenska University Hospital/östra, Göteborg, Sweden

,

Giancarlo Agnelli

²Division of Internal and Cardiovascular Medicine, University of Perugia, Perugia, Italy

,

Alexander T. Cohen

³Department of Academic Surgery, Guy’s, King’s, Thomas’ School of Medicine, London, UK

,

Ola E. Dahl

⁴Department of Orthopaedics, Research Forum, Ullevaal University Hospital, Oslo, Norway

,

Patrick Mouret

⁵Department of Orthopaedics Frankfurt-Höchst Clinic, Frankfurt, Germany

,

Nadia Rosencher

⁶Department of Orthopaedics, Cochin Hospital, Paris, France

,

Christina Eskilson

⁷AstraZeneca Research and Development, Mölndal, Sweden

,

Ingela Nylander

⁷AstraZeneca Research and Development, Mölndal, Sweden

,

Lars Frison

⁷AstraZeneca Research and Development, Mölndal, Sweden

,

Mats ögren

⁷AstraZeneca Research and Development, Mölndal, Sweden

,

on behalf of the METHRO III Study Group* (* see Appendix for METHRO III study participants)

› Institutsangaben

Abstract

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.

Keywords

Venous thromboembolism - joint replacement surgery - thrombin inhibitors - ximelagatran/melagatran - enoxaparin

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Referenzen

References
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