HealthDay News — Following nonmajor orthopedic surgery of the lower limb, rivaroxaban is superior to enoxaparin for prevention of major venous thromboembolism, according to a study published online March 29 in the New England Journal of Medicine.
C. Marc Samama, MD, from the Hôpital Cochin in Paris, and colleagues conducted an international randomized noninferiority trial involving adults undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism. Participants were randomly assigned on the basis of the investigator’s judgment to receive either rivaroxaban or enoxaparin (1809 and 1795 patients, respectively). If rivaroxaban proved to be noninferior to enoxaparin, a test for superiority was planned.
The researchers found that major venous thromboembolism occurred in 0.2% of 1661 patients in the rivaroxaban group and in 1.1% of 1640 patients in the enoxaparin group (risk ratio with multiple imputation, 0.25; P < 0.001 for noninferiority; P = 0.01 for superiority). There was no significant difference between the groups in terms of incidence of bleeding (1.1 and 1.0%, respectively, for major bleeding or nonmajor clinically relevant bleeding; 0.6 and 0.7%, respectively, for major bleeding).
“Treatment with oral rivaroxaban was superior to subcutaneous enoxaparin with regard to the prevention of venous thromboembolism in patients undergoing nonmajor orthopedic surgery with a period of immobilization,” the authors write.
The study was partially funded by Bayer.