Dabigatran versus Enoxaparin in the prevention of venous thromboembolism after total knee arthroplasty: A randomized clinical trial

BACKGROUND: Venous thromboembolism (VTE) and deep vein thrombophlebitis (DVT) is a serious problem with high mortality and morbidity rates. This study was conducted to compare efficacy and safety results of the two types of VTE preventing in patients underwent total knee arthroplasty (TKA). METHODS: Having considered exclusion criteria, 90 patients of 136 ones were registered in the study. Our patients of TKA were split randomly in two groups. Totally, 45 patients received enoxaparin, 40 mg 12 h before surgery and treated by 40 mg daily up to 15 days. The second group (45 patients) were treated by dabigatran 150 mg 4 h after surgery and 225 mg daily up to 15 days. Efficacy was evaluated by Doppler sonography after 15 days for the presence of DVT and safety was determined by 3 months follow-up for all-cause mortality and any major or minor bleedings. RESULTS: Two groups were similar in baseline characteristics. The efficacy outcome events occurred in 2.2% (2 of 90) of the patients (1 symptomatic VTE in dabigatran and 1 in the enoxaparin group) without significant statistical difference between groups (P = 0.64). In terms of safety, 3 patients (6.6%) in dabigatran and 2 patients (4.4%) in enoxaparin group had major bleeding (P = 0.66) and 8 patients (17.7%) in dabigatran and 7 patients (15.7%) in enoxaparin group had non-major bleeding event (P = 0.81). There were no death, pulmonary emboli, and cardiac events during follow-up. CONCLUSION: Three months follow-up did not show statistical difference in efficacy and safety between dabigatran and enoxaparin. Future studies with mentioning to later outcomes for checking safety are warranted.