Efficacy and Safety of the Oral Anticoagulant DIMOLEGIN Compared to Enoxaparin Sodium for the Prevention of Venous Thromboembolism Following Major Joint Replacement Surgery (hip or knee arthroplasty): A Randomized, Double-Blind, Multicenter Trial

Introduction. One of the most common complications following major joint replacement surgery (hip or knee arthroplasty) is the development of venous thromboembolism (VTE). The aim of this study was to evaluate whether the oral drug DIMOLEGIN is non-inferior in efficacy compared to subcutaneous Clexane (INN: enoxaparin sodium) as a means of preventing VTE after major joint replacement surgery. Material and methods. This was a multicenter, randomized, controlled, double-blind phase III trial with a double-dummy design, conducted according to a non-inferiority framework. The study included patients undergoing elective total hip or knee arthroplasty. The composite primary endpoint included symptomatic or asymptomatic deep vein thrombosis, non-fatal pulmonary embolism, or death from any cause. Results. A total of 215 patients were randomized into two groups: DIMOLEGIN 60 mg orally once daily (n=107) and enoxaparin sodium 40 mg subcutaneously once daily (n=108). The incidence of VTE was 3.74% in the DIMOLEGIN group versus 7.41% in the enoxaparin sodium group. The risk difference was –3.67% (97.19% confidence interval: –11.58% to 3.83%), which did not exceed the predefined non-inferiority margin of 4%. The incidence of hemorrhagic complications was comparable between the groups (19.63% vs 29.63%, p=0.123). Conclusion. Oral antigoagulant DIMOLEGIN is non-inferior to Clexane (INN: enoxaparin sodium) in the prevention of VTE following major joint replacement surgery (hip or knee arthroplasty) and demonstrates a comparable safety profile.