The primary efficacy outcome was the development of a major venous thromboembolic event such as symptomatic distal or proximal deep-vein thrombosis, asymptomatic deep vein thrombosis, pulmonary embolism or venous thromboembolism–related death during the treatment period.

Compression ultrasonography was performed between 15 days and 3 months after randomisation to diagnose asymptomatic vein thrombosis and a telephone conversation was held at day 30 of end of treatment to rule out thrombotic events. Secondary outcomes were major and minor bleeding events.

The authors reported major venous thromboembolism in 4 out of 1661 (0.2%) in the rivaroxaban group and in 18 out of 1640 patients (1.1%) in the enoxaparin group with statistical significance both in non-inferiority and superiority analysis.

Secondary variables did not differ between groups with 1.1% and 1% of the incidence of major or non-major clinically relevant bleeding in the rivaroxaban and enoxaparin groups, respectively.

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