"BRIXABAN for Acute Medical Illness". The New England Journal of Medicine. 2016.

Clinical Question

Does extended-duration thromboprophylaxis with betrixaban reduce the risk of venous thromboembolism compared to standard-duration enoxaparin in acutely ill medical patients?

Bottom Line

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.

Major Points

Guidelines

No clear guidelines were established based on this study for the extension of thromboprophylaxis after hospital discharge.

Design

Multicenter, double-blind, parallel-group, randomized, controlled trial comparing extended-duration betrixaban with standard-duration enoxaparin

Population

7,513 patients hospitalized with acute medical illnesses, reduced mobility, and additional risk factors for venous thromboembolism.

Interventions

Betrixaban for 35 to 42 days versus subcutaneous enoxaparin for 10±4 days

Outcomes

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.

Criticisms

Approximately 15% of enrolled patients did not undergo adequate ultrasonography, thus could not be included in the main analyses of the efficacy outcomes.

Funding

Supported by Portola Pharmaceuticals

Further Reading

Cohen AT, Harrington RA, Goldhaber SZ, et al. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. The New England Journal of Medicine. 2016.