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Previous Volume 358:2765-2775 June 26, 2008 Number 26 Next

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ABSTRACT

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, we assigned 4541 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 (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 pulmonary embolism, or death from venous thromboembolism). The primary safety outcome was major bleeding.

Results A total of 3153 patients were included in the superiority analysis (after 1388 exclusions), and 4433 were included in the safety analysis (after 108 exclusions). The primary efficacy outcome occurred in 18 of 1595 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 venous thromboembolism occurred in 4 of 1686 patients (0.2%) in the rivaroxaban group and in 33 of 1678 patients (2.0%) in the enoxaparin group (absolute risk reduction, 1.7%; 95% CI, 1.0 to 2.5; P<0.001). Major bleeding occurred in 6 of 2209 patients (0.3%) in the rivaroxaban group and in 2 of 2224 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, 40-mg subcutaneous dose of enoxaparin in patients undergoing elective total hip arthroplasty. The two drugs had similar safety profiles. (ClinicalTrials.gov number, NCT00329628 [ClinicalTrials.gov] .)

Source Information

From Sahlgrenska University Hospital–Östra, Gothenburg, Sweden (B.I.E.); Aarhus University Hospital, Aarhus, Denmark (L.C.B.); Medical University of South Carolina, Charleston (R.J.F.); Institute of Experimental Oncology and Therapy Research, Technical University of Munich, Munich, Germany (S.H.); Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); Thrombosis Research Institute, and Barts and the London School of Medicine, London (A.K.K.); Bayer HealthCare, Wuppertal, Germany (T.J.B., H.B., E.M., F.M.); and University of Toronto, Toronto (W.G.).

Address reprint requests to Dr. Eriksson at the Orthopedic Department, Sahlgrenska University Hospital–Östra, Smorslottsgatan 1, SE-41685 Gothenburg, Sweden, or at b.eriksson{at}orthop.gu.se.

Full Text of this Article

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