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Table 1 Efficacy and safety data from the three trials comparing dabigatran etexilate with the European enoxaparin dose as thromboprophylaxis following elective total hip or knee replacement surgery [19–21]

From: Preoperative versus postoperative initiation of thromboprophylaxis following major orthopedic surgery: safety and efficacy of postoperative administration supported by recent trials of new oral anticoagulants

 

220 mg dabigatran etexilate initiated post-surgery

150 mg dabigatran etexilate initiated post-surgery

40 mg enoxaparin initiated 12 h pre-surgery

RE-MODELâ„¢trial (knee replacement)

Total VTE and all-cause mortality (primary efficacy end-point)

183/503 (36.4%)

213/526 (40.5%)

193/512 (37.7%)

Major bleeding

10/679 (1.5%)

9/703 (1.3%)

9/694 (1.3%)

RE-NOVATE ® trial (hip replacement)

Total VTE and all-cause mortality (primary efficacy end-point)

53/880 (6.0%)

75/874 (8.6%)

60/897 (6.7%)

Major bleeding

23/1146 (2.0%)

15/1163 (1.3%)

18/1154 (1.6%)

RE-NOVATE ® II trial (hip replacement)

Total VTE and all-cause mortality (primary efficacy end-point)

61/792 (7.7%)

-

69/785 (8.8%)

Major bleeding

14/1010 (1.4%)

-

9/1003 (0.9%)

  1. VTE venous thromboembolism