"BRIXABAN for Acute Medical Illness". The New England Journal of Medicine. 2016.
Links to original sources: Wiki Journal Post Full Journal Article
Does extended-duration thromboprophylaxis with betrixaban reduce the risk of venous thromboembolism compared to standard-duration enoxaparin in acutely ill medical patients?
Extended-duration thromboprophylaxis with betrixaban did not significantly reduce the risk of venous thromboembolism in acutely ill medical patients compared to standard-duration enoxaparin in the prespecified primary efficacy cohort. Exploratory analyses suggest a possible benefit in larger patient cohorts.
The APEX trial investigated whether extended prophylaxis with betrixaban reduces venous thromboembolism in hospitalized acutely ill medical patients. Although the primary efficacy outcome did not show a significant difference between betrixaban and enoxaparin in the cohort with elevated d-dimer levels, exploratory analyses in larger cohorts indicated potential benefits of betrixaban.
No clear guidelines were established based on this study for the extension of thromboprophylaxis after hospital discharge.
Multicenter, double-blind, parallel-group, randomized, controlled trial comparing extended-duration betrixaban with standard-duration enoxaparin
7,513 patients hospitalized with acute medical illnesses, reduced mobility, and additional risk factors for venous thromboembolism.
Betrixaban for 35 to 42 days versus subcutaneous enoxaparin for 10±4 days
Primary Efficacy Outcome: Composite of asymptomatic proximal deep-vein thrombosis (DVT), symptomatic venous thromboembolism, between days 1 to 42. Primary Safety Outcome: Major bleeding up to 7 days after discontinuation of study medication. Secondary Efficacy Outcomes: Symptomatic venous thromboembolism and composite of asymptomatic proximal DVT, symptomatic DVT, nonfatal pulmonary embolism, or death from any cause through day 42.
Approximately 15% of enrolled patients did not undergo adequate ultrasonography, thus could not be included in the main analyses of the efficacy outcomes.
Supported by Portola Pharmaceuticals
Cohen AT, Harrington RA, Goldhaber SZ, et al. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. The New England Journal of Medicine. 2016.