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.

Tütüncü, Serdar; Heuschmann, Peter U; Sparenberg, Paul; Kauert, Andreas; Zeise-Wehry, Daniel; Hagemann, Georg; Waldschmidt, Carolin; Koennecke, Hans-Christian; Jungehulsing, Gerhard Jan; Dietzel, Joanna; Haas, Tobias Eberhard; Nolte, Christian H; Reis, Joschua Mirko; Fiessler, Cornelia; Schmehl, Ingo; Mackert, Bruno-Marcel; Doehner, Wolfram; Völzke, Enrico; Nabavi, Darius; Kunze, Claudia; Stingele, Robert; Hamilton, Frank; Olma, Manuel; Dimitrijeski, Boris; Honermann, Martin; Endres, Matthias; Malsch, Carolin; Schurig, Johannes; Haeusler, Karl Georg

doi:10.1007/s00415-021-10866-2

Journal Article

DZNE-2021-01442

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.

Tütüncü, S. ; Olma, M. ; Kunze, C. ; Dietzel, J. ; Schurig, J. ; Fiessler, C. ; Malsch, C. ; Haas, T. E. ; Dimitrijeski, B. ; Doehner, W. ; Hagemann, G. ; Hamilton, F. ; Honermann, M. ; Jungehulsing, G. J. ; Kauert, A. ; Koennecke, H.-C. ; Mackert, B.-M. ; Nabavi, D. ; Nolte, C. H. ; Reis, J. M. ; Schmehl, I. ; Sparenberg, P. ; Stingele, R. ; Völzke, E. ; Waldschmidt, C. ; Zeise-Wehry, D. ; Heuschmann, P. U. ; Endres, M.DZNE* ; Haeusler, K. G.

2022
Springer Berlin

Journal of neurology 269(1), 470-480 (2021) [10.1007/s00415-021-10866-2]

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Please use a persistent id in citations: doi:10.1007/s00415-021-10866-2

Abstract: We aimed to analyze prevalence and predictors of NOAC off-label under-dosing in AF patients before and after the index stroke.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.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 < 0.01; 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 < 0.01].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.NCT02306824.

Keyword(s): Administration, Oral (MeSH) ; Aged, 80 and over (MeSH) ; Anticoagulants: therapeutic use (MeSH) ; Atrial Fibrillation: complications (MeSH) ; Atrial Fibrillation: drug therapy (MeSH) ; Berlin (MeSH) ; Brain Ischemia: complications (MeSH) ; Brain Ischemia: drug therapy (MeSH) ; Humans (MeSH) ; Off-Label Use (MeSH) ; Prospective Studies (MeSH) ; Registries (MeSH) ; Stroke: complications (MeSH) ; Stroke: drug therapy (MeSH) ; Atrial fibrillation ; Ischemic stroke ; NOAC ; Under-dosing

Classification:

ddc:610

Note: ISSN 1432-1459 not unique: **2 hits**. (CC BY)

Contributing Institute(s):

Coordinator of Clinical Research (AG Endres)

Research Program(s):

353 - Clinical and Health Care Research (POF4-353) (POF4-353)

Appears in the scientific report 2022

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Medline

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