Deep vein thrombosis landmark trials in prevention
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Editor(s)-In-Chief: The APEX Trial Investigators, C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-In-Chief: Justine Cadet
Overview
Randomized trials have compared the efficacy and safety of antithrombins and anticoagulants in the prevention of deep vein thrombosis in the setting of surgical procedures and in the context of hospitalization for a medical illness.
Total Hip Replacement
RECORD 1 Study[1]
Background: This phase 3 trial compared the efficacy and safety of rivaroxaban, an oral direct inhibitor of factor Xa, with those of enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty.
Methods: In this randomized, double-blind study, the researchers assigned 4,541 patients to receive either 10 mg of oral rivaroxaban once daily, beginning after surgery, or 40 mg of enoxaparin subcutaneously once daily, beginning the evening before surgery, plus a placebo tablet or injection. The primary efficacy outcome was the composite of deep vein thrombosis (DVT) (either symptomatic or detected by bilateral venography if the patient was asymptomatic), nonfatal pulmonary embolism or death from any cause at 36 days (range, 30 to 42). The main secondary efficacy outcome was major venous thromboembolism (proximal deep-vein thrombosis, nonfatal PE or death from venous thromboembolism [VTE]). The primary safety outcome was major bleeding.
Results: A total of 3,153 patients were included in the superiority analysis (after 1,388 exclusions), and 4,433 were included in the safety analysis (after 108 exclusions). The primary efficacy outcome occurred in 18 of 1,595 patients (1.1%) in the rivaroxaban group and in 58 of 1558 patients (3.7%) in the enoxaparin group (absolute risk reduction, 2.6%; 95% confidence interval [CI], 1.5 to 3.7; P<0.001). Major VTE occurred in 4 of 1686 patients (0.2%) in the rivaroxaban group and in 33 of 1678 patients (2%) in the enoxaparin group (absolute risk reduction, 1.7%; 95% CI, 1.0 to 2.5; P<0.001). Major bleeding occurred in six of 2,209 patients (0.3%) in the rivaroxaban group and in two of 2,224 patients (0.1%) in the enoxaparin group (P=0.18).
Conclusions: A once-daily, 10-mg oral dose of rivaroxaban was significantly more effective for extended thromboprophylaxis than a once-daily, 40mg subcutaneous dose of enoxaparin in patients undergoing elective total hip arthroplasty. The two drugs had similar safety profiles.