1. Off-label-dosing of non-vitamin K-dependent oral antagonists in AF patients before and after stroke: results of the prospective multicenter Berlin Atrial Fibrillation Registry
- Author
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Daniel Zeise-Wehry, Hans-Christian Koennecke, Manuel C. Olma, Karl Georg Haeusler, Serdar Tütüncü, Andreas Kauert, Martin Honermann, Christian H. Nolte, Carolin Malsch, Georg Hagemann, Joanna Dietzel, Enrico Völzke, Boris Dimitrijeski, Johannes Schurig, Gerhard J. Jungehulsing, Darius G. Nabavi, Robert Stingele, Wolfram Doehner, Cornelia Fiessler, Peter U. Heuschmann, Joschua Mirko Reis, Frank Hamilton, Bruno-Marcel Mackert, Tobias Eberhard Haas, Paul Sparenberg, Ingo Schmehl, Carolin Waldschmidt, Claudia Kunze, and Matthias Endress
- Subjects
medicine.medical_specialty ,therapeutic use [Anticoagulants] ,complications [Atrial Fibrillation] ,Neurology ,Administration, Oral ,Brain Ischemia ,Internal medicine ,Post-hoc analysis ,medicine ,Humans ,drug therapy [Atrial Fibrillation] ,complications [Stroke] ,Dosing ,ddc:610 ,Prospective Studies ,Registries ,NOAC ,Stroke ,Neuroradiology ,Aged, 80 and over ,Under-dosing ,Rivaroxaban ,Original Communication ,Ischemic stroke ,business.industry ,Anticoagulants ,Correction ,Atrial fibrillation ,Off-Label Use ,complications [Brain Ischemia] ,medicine.disease ,drug therapy [Stroke] ,Berlin ,drug therapy [Brain Ischemia] ,Apixaban ,Neurology (clinical) ,business ,medicine.drug - Abstract
Aims We aimed to analyze prevalence and predictors of NOAC off-label under-dosing in AF patients before and after the index stroke. Methods The post hoc analysis included 1080 patients of the investigator-initiated, multicenter prospective Berlin Atrial Fibrillation Registry, designed to analyze medical stroke prevention in AF patients after acute ischemic stroke. Results At stroke onset, an off-label daily dose was prescribed in 61 (25.5%) of 239 NOAC patients with known AF and CHA2DS2-VASc score ≥ 1, of which 52 (21.8%) patients were under-dosed. Under-dosing was associated with age ≥ 80 years in patients on rivaroxaban [OR 2.90, 95% CI 1.05–7.9, P = 0.04; n = 29] or apixaban [OR 3.24, 95% CI 1.04–10.1, P = 0.04; n = 22]. At hospital discharge after the index stroke, NOAC off-label dose on admission was continued in 30 (49.2%) of 61 patients. Overall, 79 (13.7%) of 708 patients prescribed a NOAC at hospital discharge received an off-label dose, of whom 75 (10.6%) patients were under-dosed. Rivaroxaban under-dosing at discharge was associated with age ≥ 80 years [OR 3.49, 95% CI 1.24–9.84, P = 0.02; n = 19]; apixaban under-dosing with body weight ≤ 60 kg [OR 0.06, 95% CI 0.01–0.47, P n = 56], CHA2DS2-VASc score [OR per point 1.47, 95% CI 1.08–2.00, P = 0.01], and HAS-BLED score [OR per point 1.91, 95% CI 1.28–2.84, P Conclusion At stroke onset, off-label dosing was present in one out of four, and under-dosing in one out of five NOAC patients. Under-dosing of rivaroxaban or apixaban was related to old age. In-hospital treatment after stroke reduced off-label NOAC dosing, but one out of ten NOAC patients was under-dosed at discharge. Clinical trial registration NCT02306824.
- Published
- 2022
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