Key result
Off-label DOAC dosing was associated with increased 1-year all-cause mortality (OR 1.90; 95% CI 1.02-3.37; p=0.032) and 30-day readmissions (OR 1.69; 95% CI 1.11-2.54; p=0.012).
Why the study?
Data on off-label direct oral anticoagulant use are lacking, leading investigators to evaluate clinical outcomes in a racially mixed population treated for AF and VTE.
Does off-label DOAC dosing increase mortality and readmissions in patients with atrial fibrillation or venous thromboembolism?
Population
1,087 DOAC prescriptions for AF or VTE in a racially mixed population
Comparison
Off-label vs appropriate DOAC dosing
Design
Retrospective study
Follow-up
1-year
Authors
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Should not yet change DOAC dosing practice; hypothesis-generating for RCTs confirming risks in AF or VTE.
Cohort (n=1,087)
Does off-label DOAC dosing increase mortality and readmissions in patients with atrial fibrillation or venous thromboembolism?
Odds Ratio: 1.9 (95% CI 1.02–3.37)
p-value: p=0.032
Off-label dosing of DOACs is common and is associated with significantly increased risks of 30-day readmission, 1-year mortality, and new thromboembolic events when underdosed.
Aguilar et al. (2021) conducted a cohort in Atrial fibrillation and venous thromboembolism (n=1,087). Off-label DOAC dosing vs. Appropriate DOAC dosing (FDA labeling) was evaluated on 1-year all-cause mortality (OR 1.90, 95% CI 1.02-3.37, p=0.032). Off-label DOAC dosing was associated with increased 1-year all-cause mortality (OR 1.90; 95% CI 1.02-3.37; p=0.032) and 30-day readmissions (OR 1.69; 95% CI 1.11-2.54; p=0.012).
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