Naslov
Rivaroxaban for thromboprophylaxis after hospitalization for medical illness

Autori
Spyropoulos, Alex C. ; Ageno, Walter ; Albers, Gregory W. ; Elliott, C. Gregory ; Halperin, Jonathan L. ; Hiatt, William R. ; Maynard, Gregory A. ; Steg, P. Gabriel ; Weitz, Jeffrey I. ; Suh, Eunyoung ; Spiro, Theodore E. ; Barnathan, Elliot S. ; Raskob, Gary E.

Kolaboracija
MARINER Investigators

Izvornik
The New England journal of medicine (0028-4793) 379 (2018), 12; 1118-1127

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
rivaroxaban ; thromboprophylaxis ; medical illness

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA