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http://hdl.handle.net/2445/178491
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DC Field | Value | Language |
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dc.contributor.author | Cohen, Alexander T. | - |
dc.contributor.author | Harrington, Robert A. | - |
dc.contributor.author | Goldhaber, Samuel Z. | - |
dc.contributor.author | Hull, Russell D. | - |
dc.contributor.author | Wiens, Brian L. | - |
dc.contributor.author | Gold, Alex | - |
dc.contributor.author | Hernandez, Adrian F. | - |
dc.contributor.author | Gibson, C. Michael | - |
dc.contributor.author | Riera Mestre, Antoni | - |
dc.contributor.author | APEX Investigators | - |
dc.date.accessioned | 2021-06-17T13:55:45Z | - |
dc.date.available | 2021-06-17T13:55:45Z | - |
dc.date.issued | 2016-08-11 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | http://hdl.handle.net/2445/178491 | - |
dc.description.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). | - |
dc.format.extent | 11 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1601747 | - |
dc.relation.ispartof | New England Journal of Medicine, 2016, vol. 375, num. 6, p. 534-544 | - |
dc.relation.uri | https://doi.org/10.1056/NEJMoa1601747 | - |
dc.rights | (c) Massachusetts Medical Society, 2016 | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Tromboembolisme | - |
dc.subject.classification | Pacients | - |
dc.subject.classification | Factors de risc en les malalties | - |
dc.subject.other | Thromboembolism | - |
dc.subject.other | Patients | - |
dc.subject.other | Risk factors in diseases | - |
dc.title | Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 682244 | - |
dc.date.updated | 2021-06-17T13:55:45Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 27232649 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) |
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File | Description | Size | Format | |
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682244.pdf | 207.68 kB | Adobe PDF | View/Open |
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