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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Extended thromboprophylaxis with betrixaban in acutely ill medical patients
New England Journal of Medicine, Volume 375, No. 6, Year 2016
Notification
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Description
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. Copyright © 2016 Massachusetts Medical Society.
Authors & Co-Authors
Cohen, Alexander Thomas
United Kingdom, London
King's College London
Harrington, Robert A.
United States, Palo Alto
Stanford University
Goldhaber, Samuel Zachary
United States, Boston
Harvard Medical School
Hernandez, Adrian F.
United States, Durham
Duke University
Gibson, Charles Michael
United States, Boston
Beth Israel Deaconess Medical Center
Macín, Stella Maris
Unknown Affiliation
Parody, Maria Leonor
Unknown Affiliation
Poy, Carlos Alberto
Unknown Affiliation
Baker, Ross I.
Unknown Affiliation
Colquhoun, David M.
Unknown Affiliation
Finfer, Simon R.
Unknown Affiliation
Huber, Kurt
Unknown Affiliation
Pimanov, Sergey I.
Unknown Affiliation
Delforge, Marc D.
Unknown Affiliation
Motte, Serge
Unknown Affiliation
Manenti, Euler Roberto Fernandes
Unknown Affiliation
Rocha, Ana Thereza Cavalcanti
Unknown Affiliation
Saraiva, José Francisco Kerr
Unknown Affiliation
Grigorov, Mladen V.
Unknown Affiliation
Kalpachki, Rosen
Unknown Affiliation
Raev, Dimitar H.
Unknown Affiliation
Tokmakova, Mariya Petkova
Unknown Affiliation
Douketis, James Demetrios
Unknown Affiliation
Kahn, Susan R.
Unknown Affiliation
Le Gal, Gr'egoire
Unknown Affiliation
Jakopović, Marko
Unknown Affiliation
Malojčić, Branko
Unknown Affiliation
Chlumský, Jaromír
Unknown Affiliation
Mayer, Otto
Unknown Affiliation
Reiterer, Pavel
Unknown Affiliation
Storgaard, Merete
Unknown Affiliation
Marandi, Toomas
Unknown Affiliation
Airaksinen, Juhani K.E.
Unknown Affiliation
Kaaja, Risto Juhani
Unknown Affiliation
Tatlisumak, Turgut
Unknown Affiliation
Debourdeau, Philippe M.
Unknown Affiliation
Grange, Claire
Unknown Affiliation
Mismetti, Patrick
Unknown Affiliation
Paleiron, Nicolas
Unknown Affiliation
Payot, Laurent L.P.
Unknown Affiliation
Pernod, Gilles
Unknown Affiliation
Pottier, Pierre
Unknown Affiliation
Queŕé, Isabelle
Unknown Affiliation
Roy, Pierre Marie
Unknown Affiliation
Schmidt, Jeannot A.
Unknown Affiliation
Khintibidze, Irakli
Unknown Affiliation
Pagava, Zurab M.
Unknown Affiliation
Dengler, Thomas J.
Unknown Affiliation
Horacek, Thomas
Unknown Affiliation
Lapp, Harald
Unknown Affiliation
Schellong, Sebastian M.
Unknown Affiliation
Weimar, Christian
Unknown Affiliation
Zeymer, Uwe
Unknown Affiliation
Merkely, Béla D.Signla
Unknown Affiliation
Hussein, Osamah A.
Unknown Affiliation
Ageno, Walter
Unknown Affiliation
Moia, Marco
Unknown Affiliation
Novo, Salvatore
Unknown Affiliation
Yáñez, Lucrecia
Unknown Affiliation
Gaciong, Zbigniew A.
Unknown Affiliation
Gniot, Jacek R.
Unknown Affiliation
Averkov, Oleg V.
Unknown Affiliation
Barbarash, Olga Leonidovna
Unknown Affiliation
Ershova, Olga B.
Unknown Affiliation
Kobalava, Zhanna D.
Unknown Affiliation
Panchenko, Elizaveta P.
Unknown Affiliation
Simanenkov, Vladimir I.
Unknown Affiliation
Gašpar, Ludovít
Unknown Affiliation
Adler, David
Unknown Affiliation
Basson, Matthys Mde V.V.
Unknown Affiliation
Breedt, Johannes
Unknown Affiliation
Jacobson, Barry Frank
Unknown Affiliation
Mitha, Ismail Haroon
Unknown Affiliation
Jimeńez, David
Unknown Affiliation
Güneri, Sema
Unknown Affiliation
Okumuş, Gülfer
Unknown Affiliation
Godlevska, Olga
Unknown Affiliation
Body, Richard M.
Unknown Affiliation
Davis, Michael G.
Unknown Affiliation
MacCallum, Peter K.
Unknown Affiliation
Anderson, Craig S.
Unknown Affiliation
Pullman, John
Unknown Affiliation
Shammas, Nicolas W.
Unknown Affiliation
Warner, Alberta L.
Unknown Affiliation
Yusen, Roger D.
Unknown Affiliation
Zakai, Neil A.
Unknown Affiliation
Statistics
Citations: 360
Authors: 86
Affiliations: 6
Identifiers
Doi:
10.1056/NEJMoa1601747
ISSN:
00284793
Research Areas
Health System And Policy
Study Design
Randomised Control Trial
Cross Sectional Study
Cohort Study
Exploratory Study
Study Approach
Quantitative