Spyropoulos AC, et al. - Given that patients who are hospitalized for medical illness remain at risk for venous thromboembolism after discharge, experts evaluated the role of extended thromboprophylaxis in the treatment of these patients. Compared to placebo, findings did not suggest an association of rivaroxaban, given to medical patients for 45 days after hospital discharge, with a significantly lower risk of symptomatic venous thromboembolism and death due to venous thromboembolism.

Methods

• In this randomized, double-blind trial, at hospital discharge, authors assigned medically ill patients who were at increased risk for venous thromboembolism on the basis of a modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) score of 4 or higher (scores range from 0 to 10, with higher scores indicating a higher risk of venous thromboembolism) or a score of 2 or 3 plus a plasma d-dimer level of more than twice the upper limit of the normal range (defined according to local laboratory criteria) to either once-daily rivaroxaban at a dose of 10 mg (with the dose adjusted for renal insufficiency) or placebo for 45 days.
• A composite of symptomatic venous thromboembolism or death due to venous thromboembolism was the primary efficacy outcome.
• Major bleeding was the principal safety outcome.

Results

• As per data, out of the 12,024 patients who underwent randomization, 12,019 were included in the intention-to-treat analysis.
• Results demonstrated that the primary efficacy outcome occurred in 50 of 6007 patients (0.83%) who were given rivaroxaban and in 66 of 6012 patients (1.10%) who were given placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.52 to 1.09; P=0.14).
• In the rivaroxaban group, the prespecified secondary outcome of symptomatic nonfatal venous thromboembolism occurred in 0.18% of patients and in the placebo group it occurred in 0.42% of patients (hazard ratio, 0.44; 95% CI, 0.22 to 0.89).
• Researchers noted major bleeding in 17 of 5982 patients (0.28%) in the rivaroxaban group and in 9 of 5980 patients (0.15%) in the placebo group (hazard ratio, 1.88; 95% CI, 0.84 to 4.23).