Efficacy and safety of dabigatran for venous thrombosis prophylaxis after knee replacement surgery in Thai patients: a prospective non-randomized controlled trial

Abstract

Abstract Background Dabigatran, a direct oral anticoagulant, has been approved for the prevention of venous thromboembolism (VTE) after orthopedic surgery in many countries. The efficacy and safety of this agent were most studied in Western countries. Objective To assess the efficacy and safety of dabigatran in preventing venous thromboembolic diseases after total knee arthroplasty (TKA) in Asian patients. Methods We conducted a prospective nonrandomized controlled study in Thai patients undergoing TKA. Thirty-two patients received 220 mg of dabigatran once daily for 14 days as thromboprophylaxis and 32 patients in the control group received none. The primary efficacy outcome was deep vein thrombosis (DVT), which was identified by color Doppler ultrasonography and/or diagnosed pulmonary embolism (PE). The primary safety outcomes were major bleeding and clinically relevant nonmajor bleeding events. Results There were no DVTs or PEs diagnosed in either group. The difference in the composite incidence of major and clinically relevant nonmajor bleedings between the dabigatran and control groups did not reach significant (6.2% vs. 0%, P = 0.15). Conclusion Dabigatran might have no clear benefit for the prevention of VTE after TKA in Thai patients. We do not recommend the routine use of dabigatran as a chemical thromboprophylaxis after TKA in Thai patients. To determine the safety profile, further study with larger sample sizes is required.