Dabigatran etexilate and LMWH for the prevention of venous thromboembolism in 532 patients undergoing hip surgery.

OBJECTIVE Patients undergoing total hip replacement (THR) are at high risk of venous thromboembolism (VTE) and according to guidelines they should receive pharmacological prophylaxis. We would like to compare the efficacy, adherence and safety of dabigatran and low molecular weight heparins (LMWH) for the prevention of VTE in patients who underwent THR. PATIENTS AND METHODS This study enrolled patients undergoing THR treated with dabigatran (110 mg loading dose then 220 mg/day for 34 days) or the LMWH dalteparin (2500 IU, 6-8 hours before surgery then 5000 IU/day for 35 days). The primary endpoint was adherence to treatment. RESULTS Of the 532 patients screened and enrolled in the study, 407 (mean age 57.7 ± 12.3 years) completed the study (211 dabigatran, 196 LMWH). Over the 35 days of treatment, adherence was comparable between dabigatran and LMWH: 10.9% and 14.3% of patients receiving dabigatran and LMWH treatment missed > 1 dose of the drug, respectively. There was a lower need for external support in patients who received dabigatran (8.5% vs 58.2%; p < 0.0001) and a lower number of patients receiving dabigatran required support by a professional nurse (1.4% vs 17.3% of patients with LMWH; p < 0.0001). Dabigatran and LMWH were similarly well tolerated; however, fewer patients receiving dabigatran reported bleeding events. CONCLUSIONS This study demonstrates that dabigatran is associated with high adherence. A lower need for external support in patients who received dabigatran may provide an added benefit compared with other oral treatments for VTE prophylaxis.