Extended-duration betrixaban versus shorter-duration enoxaparin for venous thromboembolism prophylaxis in critically ill medical patients: an APEX trial substudy
| Autor: | Alexander T. Cohen, Russell D. Hull, Adrian F. Hernandez, Yuyin Liu, Mehrian Jafarizade, Samuel Z. Goldhaber, Robert A. Harrington, Gerald Chi, C. Michael Gibson, Sadaf Sharfaei, Farima Kahe, Arzu Kalayci |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Pyridines Critical Illness Population Critical Care and Intensive Care Medicine Asymptomatic law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine law Risk Factors Anesthesiology Internal medicine medicine Humans Enoxaparin education Aged Aged 80 and over education.field_of_study business.industry Anticoagulants 030208 emergency & critical care medicine Venous Thromboembolism Middle Aged medicine.disease Thrombosis Intensive care unit Apex (geometry) Venous thrombosis 030228 respiratory system chemistry Betrixaban Benzamides Female Pre-Exposure Prophylaxis medicine.symptom business Factor Xa Inhibitors |
| Zdroj: | Intensive care medicine. 45(4) |
| ISSN: | 1432-1238 |
| Popis: | To assess the efficacy and safety of betrixaban for venous thromboembolism (VTE) prophylaxis among critically ill patients. The APEX trial randomized 7513 acutely ill hospitalized patients to betrixaban for 35–42 days or enoxaparin for 10 ± 4 days. Among those, 703 critically ill patients admitted to the intensive care unit were included in the analysis, and 547 patients who had no severe renal insufficiency or P-glycoprotein inhibitor use were included in the full-dose stratum. The risk of VTE, bleeding, net clinical benefit (composite of VTE and major bleeding), and mortality was compared at 35–42 days and at 77 days. At 35–42 days, extended betrixaban reduced the risk of VTE (4.27% vs 7.95%, P = 0.042) without causing excess major bleeding (1.14% vs 3.13%, P = 0.07). Both VTE (3.32% vs 8.33%, P = 0.013) and major bleeding (0.00% vs 3.26%, P = 0.003) were decreased in the full-dose stratum. Patients who received betrixaban had more non-major bleeding than enoxaparin (overall population: 2.56% vs 0.28%, P = 0.011; full-dose stratum: 3.32% vs 0.36%, P = 0.010). Mortality was similar at the end of study (overall population: 13.39% vs 16.19%, P = 0.30; full-dose stratum: 13.65% vs 16.30%, P = 0.39). Compared with shorter-duration enoxaparin, critically ill medical patients who received extended-duration betrixaban had fewer VTE without more major bleeding events. The benefit of betrixaban was driven by preventing asymptomatic thrombosis and offset by an elevated risk of non-major bleeding. The APEX trial did not stratify by intensive care unit admission and the present study included a highly selected population of critically ill patients. These hypothesis-generating findings need to be validated in future studies. http://www.clinicaltrials.gov . Unique identifier: NCT01583218. |
| Databáze: | OpenAIRE |
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