August 26, 2018Open Access
View Full PaperRivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness
Key Result
Rivaroxaban for 45 days post-discharge did not significantly reduce symptomatic venous thromboembolism or VTE-related death compared to placebo (HR 0.76; 95% CI 0.52-1.09; P=0.14).
Study Design
Type
RCT (n=12,024)
Blinding
double-blind
Randomization
randomized
Structured PICO
Does rivaroxaban reduce the composite of symptomatic venous thromboembolism or death due to venous thromboembolism in medically ill patients at increased risk for VTE after hospital discharge?
P
Population
12,024 medically ill patients at increased risk for venous thromboembolism, followed for 45 days after hospital discharge.
I
Intervention
Rivaroxaban 10 mg once daily (dose adjusted for renal insufficiency) for 45 days after hospital discharge.
C
Comparator
Placebo for 45 days.
O
Outcome
Composite of symptomatic venous thromboembolism or death due to venous thromboembolism.composite
Rivaroxaban given for 45 days after hospital discharge to medically ill patients did not significantly reduce the risk of symptomatic VTE or VTE-related death compared to placebo.
Main Result
Hazard Ratio: 0.76 (95% CI 0.52–1.09)
Absolute Event Rate: 0.83% vs 1.1%
p-value: p=0.14
Abstract
BACKGROUND: Patients who are hospitalized for medical illness remain at risk for venous thromboembolism after discharge, but the role of extended thromboprophylaxis in the treatment of such patients is a subject of controversy. METHODS: In this randomized, double-blind trial, 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) were assigned at hospital discharge to either once-daily rivaroxaban at a dose of 10 mg (with the dose adjusted for renal insufficiency) or placebo for 45 days. The primary efficacy outcome was a composite of symptomatic venous thromboembolism or death due to venous thromboembolism. The principal safety outcome was major bleeding. RESULTS: Of the 12,024 patients who underwent randomization, 12,019 were included in the intention-to-treat analysis. 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). The prespecified secondary outcome of symptomatic nonfatal venous thromboembolism occurred in 0.18% of patients in the rivaroxaban group and 0.42% of patients in the placebo group (hazard ratio, 0.44; 95% CI, 0.22 to 0.89). Major bleeding occurred 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). CONCLUSIONS: Rivaroxaban, given to medical patients for 45 days after hospital discharge, was not associated with a significantly lower risk of symptomatic venous thromboembolism and death due to venous thromboembolism than placebo. The incidence of major bleeding was low. (Funded by Janssen Research and Development; MARINER ClinicalTrials.gov number, NCT02111564 .).