Key result
Older age was independently associated with DOAC levels above the upper limit peak range (OR 1.046), while dabigatran use compared to apixaban was associated with levels below the lower limit trough range (OR 6.060).
Why the study?
DOAC levels are frequently measured despite routine monitoring not being recommended, but it remains unclear which patients are at risk for levels outside expected ranges.
Observational (n=597)
Yes
Odds Ratio: 1.046 (95% CI 1.025–1.068)
p-value: p=<=0.001
A substantial proportion of patients in clinical practice have DOAC levels outside expected ranges, particularly older patients, those with renal impairment, and those on interacting medications, highlighting the potential need for targeted monitoring.
May support selective DOAC level checks in older patients or dabigatran users; leaves open whether monitoring improves outcomes.
Routine monitoring direct oral anticoagulants (DOAC) is not recommended, yet DOAC levels are frequently measured in clinical practice. Interpretation of levels, especially those outside expected ranges, is challenging. Until now it's unclear which patients are at risk for these levels. Identify clinical characteristics of patients with DOAC levels outside expected ranges. Patients of 2 Dutch academic medical centers with a DOAC concentration measured between 2012 and 2019 were included. DOAC levels above upper limit peak and below lower limit trough ranges, based on DOAC registration trials, were assigned outside expected range. Differences between patients were evaluated using Chi-square, independent sample-T tests and multivariable logistic regression analysis. Of 597 patients with DOAC measurement, 108 (18.1%) had levels outside expected ranges. Compared to patients with levels within range, patients with levels above range (n = 64) were older (71.1 vs. 60.6 years), more often had creatinine clearance <50 ml/min (32.8% vs. 13.9%). and used more often interacting (17.2% vs. 6.7%) and/or antiplatelet co-medication (25.0% vs. 13.1%). Patients with levels above (62.5%) and below range (61.4%) more often had atrial fibrillation as DOAC indication versus patients with levels within range (39.1%). Age (OR 1.046 [1.025–1.068]) was associated with levels above range, while dabigatran versus apixaban was associated with levels below range (OR 6.060 [1.836–19.996]). Particularly older aged patients with additional comorbidity and co-medication had DOAC levels outside expected ranges. Prospective studies are essential to investigate whether identification of patients with levels outside expected ranges is necessary to reduce the risk of clinically relevant adverse events.
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Braeken et al. (2023) conducted an observational in Atrial fibrillation or venous thromboembolism requiring DOAC therapy (n=597). Older age vs. Younger age was evaluated on DOAC level above the upper limit peak range (OR 1.046, 95% CI 1.025-1.068, p=<=0.001). Older age was independently associated with DOAC levels above the upper limit peak range (OR 1.046), while dabigatran use compared to apixaban was associated with levels below the lower limit trough range (OR 6.060).
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