Comparable efficacy of 100 mg aspirin twice daily and rivaroxaban for venous thromboembolism prophylaxis following primary total hip arthroplasty: a randomized controlled trial

研究概要

Seventy-eight patients undergoing a unilateral total hip arthroplasty (THA) were randomized in this non-inferiority trial to receive 5 weeks of aspirin (100 mg twice per day; n=37) or 5 weeks of rivaroxaban (10 mg once per day) post-operation for the prevention of deep vein thrombosis (DVT). The primary outcome of interest was the incidence of DVT which was assessed using Doppler ultrasonography at post-operative days 14 and 30, as well as calf and thigh circumference post-operation, intra-operative blood loss, intra-operative transfusion, and total blood loss. Secondary outcomes of interest included Harris Hip Score (HHS) at 30 and 90 days post-operation, time to stand-up, length of hospital stay, and the incidence of adverse events up to 90 days post-operation. Results of the study revealed no statistical significant differences between the aspirin and rivaroxaban groups for the incidence of DVT (p=0.91), intra-operative blood loss (p=0.57), intra-operative transfusion (p=0.95), and total blood loss (p=0.12). Moreover, no statistical significant differences in thigh or calf circumference post-operation were observed between the two groups (p=0.06, p=0.25; respectively). Similarly, no statistical significant differences were observed between the aspirin and rivaroxaban groups in HHS scores at 30 days (p=0.67) and 90 days (p=0.44) post-operation, time to stand-up (p=0.83), and length of stay (p=0.32). No statistically significant differences in the incidence of gastrointestinal events (p=0.29), bleeding events (p=0.33), DVT events (p=0.91), systematic complications (p=0.33), or wound complications (p=0.30) at 90 days post-operation were observed between the two groups. Also, no cases of mortality or pulmonary embolism were observed in either group.