Naslov
Rivaroxaban for thromboprophylaxis in acute ill medical patients

Autori
Cohen, AT ; Spiro, TE ; Buller, HR ; Haskell, L ; Hu, D ; Hull, R ; Mebazaa, A ; Merli, G ; Schellong, S ; Spyropoulos, AC ; Tapson, V. ; ... ; Knežević, Aleksandar ; ...

Izvornik
The New England journal of medicine (0028-4793) 368 (2013), 6; 513-523

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

Sažetak
The clinically appropriate duration of thromboprophylaxis in hospitalized patients with acute medical illnesses is unknown. In this multicenter, randomized, double-blind trial, we evaluated the efficacy and safety of oral rivaroxaban administered for an extended period, as compared with subcutaneous enoxaparin administered for a standard period, followed by placebo. We randomly assigned patients 40 years of age or older who were hospitalized for an acute medical illness to receive subcutaneous enoxaparin, 40 mg once daily, for 10±4 days and oral placebo for 35±4 days or to receive subcutaneous placebo for 10±4 days and oral rivaroxaban, 10 mg once daily, for 35±4 days. The primary ef - ficacy outcomes were the composite of asymptomatic proximal or symptomatic venous thromboembolism up to day 10 (noninferiority test) and up to day 35 (supe - riority test). The principal safety outcome was the composite of major or clinically relevant nonmajor bleeding. A total of 8101 patients underwent randomization. A primary efficacy outcome event occurred in 78 of 2938 patients (2.7%) receiving rivaroxaban and 82 of 2993 patients (2.7%) receiving enoxaparin at day 10 (relative risk with rivaroxaban, 0.97 ; 95% confidence interval [CI], 0.71 to 1.31 ; P = 0.003 for noninferiority) and in 131 of 2967 patients (4.4%) who received rivaroxaban and 175 of 3057 patients (5.7%) who received enoxaparin followed by placebo at day 35 (relative risk, 0.77 ; 95% CI, 0.62 to 0.96 ; P = 0.02). A principal safety outcome event occurred in 111 of 3997 patients (2.8%) in the rivaroxaban group and 49 of 4001 patients (1.2%) in the enoxaparin group at day 10 (P<0.001) and in 164 patients (4.1%) and 67 patients (1.7%) in the respective groups at day 35 (P<0.001). In acutely ill medical patients, rivaroxaban was noninferior to enoxaparin for stan - dard-duration thromboprophylaxis. Extended-duration rivaroxaban reduced the risk of venous thromboembolism. Rivaroxaban was associated with an increased risk of bleeding.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

Napomena
MAGELLAN Investigators.

POVEZANOST RADA