The express study: preliminary results.
The phase III trial EXPRESS was a randomised, double-blind comparison of two anticoagulant therapies used as prophylaxis against venous thromboembolism (VTE) during major elective orthopaedic surgery. The investigational treatment was ximelagatran/melagatran (Exanta), a new direct thrombin inhibitor in both its oral and subcutaneously injectable forms; the comparator was the low molecular weight heparin enoxaparin. Results showed ximelagatran/melagatran was highly statistically significantly superior to enoxaparin in preventing VTE with a relative risk reduction in proximal deep vein thrombosis plus pulmonary embolism of 63.3% (p < 0.000002). The relative risk reduction for total VTE was 23.6% (p < 0.0003). There were no differences in clinically important bleeding events (fatal bleeding, critical organ bleeding and bleeding requiring reoperation) but excess bleeding assessed subjectively was more common in the ximelagatran group than in the enoxaparin group.
Glynn
Owen
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D000328:Adult; D000925:Anticoagulants / Q000627:therapeutic use*; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects*; D004311:Double-Blind Method; D017558:Elective Surgical Procedures / Q000379:methods; D006801:Humans; D011655:Pulmonary Embolism / Q000188:drug therapy* / Q000517:prevention & control / Q000601:surgery; D020246:Venous Thrombosis / Q000188:drug therapy* / Q000517:prevention & control / Q000601:surgery
D000925:Anticoagulants