ORLANDO—A new oral anticoagulant in development, dabigatran etexilate, was shown to be as effective and safe as the low-molecular-weight enoxaparin in prophylaxis of thromboembolism in patients undergoing total knee replacement surgery.
Bengt I. Eriksson, MD, reported these results on behalf of the RE-MODEL study group during the 2006 annual meeting of the American Society of Hematology in December.
The RE-MODEL study was a large multicenter study conducted in 2010 patients undergoing elective total knee surgery in Europe, South Africa, and Australia.
Patients were randomized to receive subcutaneous injections of enoxaparin (40 mg, once daily) or to one of 2 doses of oral dabigatran etexilate (150 mg or 220 mg once daily) for 8 ± 2 days. Enoxaparin was administered 12 hours prior to surgery while dabigatran was administered 1-4 hours after the surgery.
Dabigatran etexilate met the prespecified primary endpoint of noninferiority versus enoxaparin. There was no difference in the incidence of total venous thromboembolism and all-cause mortality between the dabigatran 220 mg and 150 mg treatment arms and enoxaparin (36%, 41%, 38%, respectively).
The secondary efficacy endpoint, the incidence of proximal deep vein thrombosis and/or pulmonary embolism was similar in all treatment arms: 4%, 3%, and 4% of patients receiving dabigatran 220 mg, dabigatran 150 mg, and enoxaparin, respectively.
There was no difference among all treatment arms in bleeding rates (either major or any bleedings), and there were no signs of liver toxicity in the dabigatran arm.
Patients undergoing knee replacement surgery are at an increased risk of developing thromboembolism. Dabigatran etexilate is an oral direct thrombin inhibitor, and offers a convenient fixed oral dosing with no need for coagulation monitoring.
