TY - JOUR
T1 - Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II)
T2 - A randomised, double-blind, non-inferiority trial
AU - Eriksson, Bengt I.
AU - Dahl, Ola E.
AU - Huo, Michael H.
AU - Kurth, Andreas A.
AU - Hantel, Stefan
AU - Hermansson, Karin
AU - Schnee, Janet M.
AU - Friedman, Richard J.
PY - 2011/4
Y1 - 2011/4
N2 - This trial compared the efficacy and safety of oral dabigatran, a direct thrombin inhibitor, versus subcutaneous enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty. A total of 2,055 patients were randomised to 28-35 days treatment with oral dabigatran, 220 mg once-daily, starting with a half-dose 1-4 hours after surgery, or subcutaneous enoxaparin 40 mg once-daily, starting the evening before surgery. The primary efficacy outcome was a composite of total venous thromboembolism [VTE] (venographic or symptomatic) and death from all-causes. The main secondary composite outcome was major VTE (proximal deep-vein thrombosis or non-fatal pulmonary embolism) plus VTE-related death. The main safety outcome was major bleeding. In total, 2,013 were treated, of whom 1,577 operated patients were included in the primary efficacy analysis. The primary efficacy outcome occurred in 7.7% of the dabigatran group versus 8.8% of the enoxaparin group, risk difference (RD) -1.1% (95%CI -3.8 to 1.6%); p<0.0001 for the pre-spec-ified non-inferiority margin. Major VTE plus VTE-related death occurred in 2.2% of the dabigatran group versus 4.2% of the enoxaparin group, RD -1.9% (-3.6% to -0.2%); p=0.03. Major bleeding occurred in 1.4% of the dabigatran group and 0.9% of the enoxaparin group (p=0.40). The inci-dence of adverse events, including liver enzyme elevations and cardiac events, during treatment was similar between the groups. Extended pro-phylaxis with oral dabigatran 220 mg once-daily was as effective as sub-cutaneous enoxaparin 40 mg once-daily in reducing the risk of VTE after total hip arthroplasty, and superior to enoxaparin for reducing the risk of major VTE. The risk of bleeding and safety profiles were similar.
AB - This trial compared the efficacy and safety of oral dabigatran, a direct thrombin inhibitor, versus subcutaneous enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty. A total of 2,055 patients were randomised to 28-35 days treatment with oral dabigatran, 220 mg once-daily, starting with a half-dose 1-4 hours after surgery, or subcutaneous enoxaparin 40 mg once-daily, starting the evening before surgery. The primary efficacy outcome was a composite of total venous thromboembolism [VTE] (venographic or symptomatic) and death from all-causes. The main secondary composite outcome was major VTE (proximal deep-vein thrombosis or non-fatal pulmonary embolism) plus VTE-related death. The main safety outcome was major bleeding. In total, 2,013 were treated, of whom 1,577 operated patients were included in the primary efficacy analysis. The primary efficacy outcome occurred in 7.7% of the dabigatran group versus 8.8% of the enoxaparin group, risk difference (RD) -1.1% (95%CI -3.8 to 1.6%); p<0.0001 for the pre-spec-ified non-inferiority margin. Major VTE plus VTE-related death occurred in 2.2% of the dabigatran group versus 4.2% of the enoxaparin group, RD -1.9% (-3.6% to -0.2%); p=0.03. Major bleeding occurred in 1.4% of the dabigatran group and 0.9% of the enoxaparin group (p=0.40). The inci-dence of adverse events, including liver enzyme elevations and cardiac events, during treatment was similar between the groups. Extended pro-phylaxis with oral dabigatran 220 mg once-daily was as effective as sub-cutaneous enoxaparin 40 mg once-daily in reducing the risk of VTE after total hip arthroplasty, and superior to enoxaparin for reducing the risk of major VTE. The risk of bleeding and safety profiles were similar.
KW - Dabigatran etexilate
KW - Oral anticoagulant
KW - Prophylaxis
KW - Total hip arthroplasty
KW - Venous thromboembolism
UR - http://www.scopus.com/inward/record.url?scp=79953836474&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79953836474&partnerID=8YFLogxK
U2 - 10.1160/TH10-10-0679
DO - 10.1160/TH10-10-0679
M3 - Article
C2 - 21225098
AN - SCOPUS:79953836474
SN - 0340-6245
VL - 105
SP - 721
EP - 729
JO - Thrombosis and Haemostasis
JF - Thrombosis and Haemostasis
IS - 4
ER -