| Author/Editor | Cohen, Alexander T.; Spiro, Theodore E.; Büller, Harry R.; Haskell, Lloyd; Hu, Dayi; Hull, Russel D.; Mebazza, Alexandre; Merli, Geno; Schellong, Sebastian; Spyropoulos, Alex C.; Fležar, Matjaž; Gorjup, Vesna; Jereb, Matjaž; Sok, Mihael; Tratar, Gregor | |
| Title | Rivaroxaban for thromboprophylaxis in acutely ill medical patients | |
| Type | članek | |
| Vol. and No. | Letnik 368, št. 6 | |
| Publication year | 2013 | |
| Volume | str. 513-523 | |
| ISSN | 0028-4793 - The New England journal of medicine | |
| Language | eng | |
| Abstract | BackgroundThe clinically appropriate duration of thromboprophylaxis in hospitalized patientswith acute medical illnesses is unknown. In this multicenter, randomized, doubleblindtrial, we evaluated the efficacy and safety of oral rivaroxaban administered foran extended period, as compared with subcutaneous enoxaparin administered for astandard period, followed by placebo. MethodsWe randomly assigned patients 40 years of age or older who were hospitalized for anacute medical illness to receive subcutaneous enoxaparin, 40 mg once daily, for104 days and oral placebo for 354 days or to receive subcutaneous placebo for104 days and oral rivaroxaban, 10 mg once daily, for 354 days. The primary efficacyoutcomes were the composite of asymptomatic proximal or symptomaticvenous thromboembolism up to day 10 (noninferiority test) and up to day 35 (superioritytest). The principal safety outcome was the composite of major or clinicallyrelevant nonmajor bleeding. ResultsA total of 8101 patients underwent randomization. A primary efficacy outcome eventoccurred 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 of2967 patients (4.4%) who received rivaroxaban and 175 of 3057 patients (5.7%) whoreceived enoxaparin followed by placebo at day 35 (relative risk, 0.77; 95% CI, 0.62 to0.96; 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 enoxaparingroup at day 10 (P<0.001) and in 164 patients (4.1%) and 67 patients (1.7%) in therespective groups at day 35 (P<0.001).ConclusionsIn acutely ill medical patients, rivaroxaban was noninferior to enoxaparin for standard-duration thromboprophylaxis. Extended-duration rivaroxaban reduced the riskof venous thromboembolism. Rivaroxaban was associated with an increased risk ofbleeding. | |
| Keywords | thromboprophylaxis cute medical illnesses |