Rivaroxaban, an oral factor Xa inhibitor, was compared to standard anticoagulant therapy (enoxaparin followed by a vitamin K antagonist) in a randomized, open-label, noninferiority trial involving 4832 patients with acute symptomatic pulmonary embolism. The study found that rivaroxaban was noninferior to standard therapy for the treatment of pulmonary embolism, with similar rates of recurrent venous thromboembolism and bleeding. Rivaroxaban was taken at 15 mg twice daily for 3 weeks, followed by 20 mg once daily, while standard therapy involved enoxaparin followed by a vitamin K antagonist. The primary efficacy outcome was symptomatic recurrent venous thromboembolism, with a hazard ratio of 1.12 (95% CI, 0.75 to 1.68) in favor of rivaroxaban. The principal safety outcome, major or clinically relevant nonmajor bleeding, occurred in 10.3% of rivaroxaban patients and 11.4% of standard therapy patients, with a hazard ratio of 0.90 (95% CI, 0.76 to 1.07). Major bleeding was less frequent in the rivaroxaban group (1.1%) compared to the standard therapy group (2.2%). Rivaroxaban showed a potentially improved benefit-risk profile. The study was funded by Bayer HealthCare and Janssen Pharmaceuticals. The findings support the use of rivaroxaban as a single oral agent for the treatment of venous thromboembolism.Rivaroxaban, an oral factor Xa inhibitor, was compared to standard anticoagulant therapy (enoxaparin followed by a vitamin K antagonist) in a randomized, open-label, noninferiority trial involving 4832 patients with acute symptomatic pulmonary embolism. The study found that rivaroxaban was noninferior to standard therapy for the treatment of pulmonary embolism, with similar rates of recurrent venous thromboembolism and bleeding. Rivaroxaban was taken at 15 mg twice daily for 3 weeks, followed by 20 mg once daily, while standard therapy involved enoxaparin followed by a vitamin K antagonist. The primary efficacy outcome was symptomatic recurrent venous thromboembolism, with a hazard ratio of 1.12 (95% CI, 0.75 to 1.68) in favor of rivaroxaban. The principal safety outcome, major or clinically relevant nonmajor bleeding, occurred in 10.3% of rivaroxaban patients and 11.4% of standard therapy patients, with a hazard ratio of 0.90 (95% CI, 0.76 to 1.07). Major bleeding was less frequent in the rivaroxaban group (1.1%) compared to the standard therapy group (2.2%). Rivaroxaban showed a potentially improved benefit-risk profile. The study was funded by Bayer HealthCare and Janssen Pharmaceuticals. The findings support the use of rivaroxaban as a single oral agent for the treatment of venous thromboembolism.