Key result
Day 8 dabigatran trough ≥243.9 ng/mL linked to 1-year bleeding in geriatric AF.
Why the study?
Few geriatric patients were included in studies on direct oral anticoagulants and data on dabigatran concentration and safety are needed in this population.
Do dabigatran plasma concentrations predict bleeding events in hospitalized geriatric patients with atrial fibrillation?
Cohort (n=68)
No
Do dabigatran plasma concentrations predict bleeding events in hospitalized geriatric patients with atrial fibrillation?
In geriatric patients with atrial fibrillation, high dabigatran trough concentrations at day 8 are predictive of subsequent bleeding events, suggesting a role for early therapeutic drug monitoring in this vulnerable population.
May support trough monitoring to flag bleeding risk in hospitalized geriatric AF patients; leaves open need for prospective validation.
BACKGROUND: Few geriatric patients were included in studies on direct oral anticoagulants and data on dabigatran concentration and safety are needed in this population. Our objectives were to evaluate peak and trough dabigatran plasma concentrations over time in a geriatric population and to identify factors associated with dabigatran plasma concentrations and to assess the relationship with bleeding events. METHODS: Peak and trough dabigatran plasma concentration were performed 4,8,15,30,45 days after inception of dabigatran treatment in 68 consecutive patients ≥75 years old hospitalized in a geriatric hospital with atrial fibrillation. Bleeding events were monitored for 1 year. RESULTS: Mean age was 85.8(5.1) years old and 76.5% were women. Overall, 541 dabigatran plasma measurements (270 peak, 271 trough) were performed. Mean dabigatran concentrations of the 5 sequential measurements ranged 106-146ng/mL for peak and 66-84ng/mL for trough. Renal failure was associated with high peak and trough dabigatran concentration. Inter- and intra-individual coefficients of variation were 59.5% and 44.7% for peak and 74.5% and 44.6% for trough. Participants in the lower two tertiles of dabigatran concentration at day 8 (D8) remained below the 90th percentile (243.9ng/ml) on the next measurements. Bleeding events were associated with high trough dabigatran concentrations. Trough dabigatran concentration at D8>243.9ng/mL significantly predicted bleeding. CONCLUSION: In this geriatric population, renal function and low albumin were associated with dabigatran concentrations. Despite large variability, participants in the lower two tertiles of dabigatran concentration at D8 remained below the 90th percentile on the following measurements. D8 dabigatran trough concentration≥243.9ng/mL identified patients at risk of bleeding.
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Chaussade et al. (2017) conducted a cohort in Atrial fibrillation (n=68). Dabigatran plasma concentration was evaluated on Peak and trough dabigatran plasma concentrations over time and bleeding events. In hospitalized geriatric patients with atrial fibrillation, a day 8 dabigatran trough concentration ≥243.9 ng/mL significantly predicted bleeding events over 1 year.
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