| Title: |
Extended thromboprophylaxis with betrixaban in acutely ill medical patients |
| Authors: |
Cohen, Alexander T; Harrington, Robert A.; Goldhaber, Samuel Z.; Hull, Russell D.; Wiens, Brian L.; Gold, Alex; Hernandez, Adrian F.; Gibson, C. Michael; Investigators; Italy (261 patients, 19 sites; W. Ageno, I; Cerveri, A.; D’Angelo, A; De Pellegrin, D; Imberti, R.; Landolfi, G; LEMBO, Giuseppe; Lodigiani, M; Luisetti, M. |
| Contributors: |
Cohen, Alexander T; Harrington, Robert A.; Goldhaber, Samuel Z.; Hull, Russell D.; Wiens, Brian L.; Gold, Alex; Hernandez, Adrian F.; Gibson, C. Michael; Investigators; Italy (261 patients, 19 site; W. Ageno, I; Cerveri, A.; D’Angelo, A; De Pellegrin, D; Imberti, R.; Landolfi, G; Lembo, Giuseppe; Lodigiani, M; Luisetti, M. |
| Publisher Information: |
Massachussetts Medical Society |
| Publication Year: |
2016 |
| Collection: |
Sapienza Università di Roma: CINECA IRIS |
| Subject Terms: |
Acute Disease; Adult; Aged; Benzamide; Double-Blind Method; Drug Administration Schedule; Factor Xa Inhibitor; Female; Fibrin Fibrinogen Degradation Product; Hemorrhage; Hospitalization; Human; Male; Middle Aged; Pulmonary Embolism; Pyridine; Risk Factor; Venous Thromboembolism; Venous Thrombosi; Medicine (all) |
| 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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/27232649; info:eu-repo/semantics/altIdentifier/wos/WOS:000382193100006; volume:375; issue:6; firstpage:534; lastpage:544; numberofpages:11; journal:NEW ENGLAND JOURNAL OF MEDICINE; http://hdl.handle.net/11573/884978 |
| DOI: |
10.1056/NEJMoa1601747 |
| Availability: |
http://hdl.handle.net/11573/884978; https://doi.org/10.1056/NEJMoa1601747; http://wwwnejmorg/doi/pdf/101056/NEJMoa1601747 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.82005F8E |
| Database: |
BASE |