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http://hdl.handle.net/2445/178491
Title: | Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients |
Author: | Cohen, Alexander T. Harrington, Robert A. Goldhaber, Samuel Z. Hull, Russell D. Wiens, Brian L. Gold, Alex Hernandez, Adrian F. Gibson, C. Michael Riera Mestre, Antoni APEX Investigators |
Keywords: | Tromboembolisme Pacients Factors de risc en les malalties Thromboembolism Patients Risk factors in diseases |
Issue Date: | 11-Aug-2016 |
Publisher: | Massachusetts Medical Society |
Abstract: | Background: patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown. Methods: patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding. Results: a total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55). Conclusions: among acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218). |
Note: | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1601747 |
It is part of: | New England Journal of Medicine, 2016, vol. 375, num. 6, p. 534-544 |
URI: | http://hdl.handle.net/2445/178491 |
Related resource: | https://doi.org/10.1056/NEJMoa1601747 |
ISSN: | 0028-4793 |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) |
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