Rivaroxaban for thromboprophylaxis in acutely ill medical patients

Cohen, Alexander T., Spiro, Theodore E., Buller, Harry R., Haskell, Lloyd, Hu, Dayi, Hull, Russell, Mebazaa, Alexandre, Merli, Geno, Schellong, Sebastian, Spyropoulos, Alex C. and Tapson, Victor (2013) Rivaroxaban for thromboprophylaxis in acutely ill medical patients. New England Journal of Medicine, 368 6: 513-523. doi:10.1056/NEJMoa1111096

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Author Cohen, Alexander T.
Spiro, Theodore E.
Buller, Harry R.
Haskell, Lloyd
Hu, Dayi
Hull, Russell
Mebazaa, Alexandre
Merli, Geno
Schellong, Sebastian
Spyropoulos, Alex C.
Tapson, Victor
Title Rivaroxaban for thromboprophylaxis in acutely ill medical patients
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
Publication date 2013-02-07
Year available 2013
Sub-type Article (original research)
DOI 10.1056/NEJMoa1111096
Open Access Status File (Publisher version)
Volume 368
Issue 6
Start page 513
End page 523
Total pages 11
Place of publication Waltham, MA, United States
Publisher Massachusetts Medical Society
Language eng
Abstract Background
Formatted abstract
Background: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.

Methods: 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 efficacy outcomes were the composite of asymptomatic proximal or symptomatic venous thromboembolism up to day 10 (noninferiority test) and up to day 35 (superiority test). The principal safety outcome was the composite of major or clinically relevant nonmajor bleeding.

Results: 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).

Conclusions: In acutely ill medical patients, rivaroxaban was noninferior to enoxaparin for standard-duration thromboprophylaxis. Extended-duration rivaroxaban reduced the risk of venous thromboembolism. Rivaroxaban was associated with an increased risk of bleeding. (Funded by Bayer HealthCare Pharmaceuticals and Janssen Research and Development; MAGELLAN ClinicalTrials.gov number, NCT00571649.) Copyright
Keyword Medicine, General & Internal
General & Internal Medicine
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 189 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 218 times in Scopus Article | Citations
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