Determinants of label non-adherence to non-vitamin K oral anticoagulants in patients with newly diagnosed atrial fibrillation

J Seelig; E M Trinks-Roerdink; G Chu; R Pisters; Ljhj Theunissen; S A Trines; L Pos; Cjhj Kirchhof; Sfams de Jong; F R den Hartog; A P van Alem; P E Polak; R G Tieleman; P H van der Voort; T Lenderink; A M Otten; Jssg de Jong; Y L Gu; Jglm Luermans; Mjha Kruip; Saj Timmer; Tac de Vries; H Ten Cate; G J Geersing; F H Rutten; M V Huisman; Mew Hemels

doi:10.1093/ehjopen/oeac022

Determinants of label non-adherence to non-vitamin K oral anticoagulants in patients with newly diagnosed atrial fibrillation

J Seelig^*, E M Trinks-Roerdink, G Chu, R Pisters, Ljhj Theunissen, S A Trines, L Pos, Cjhj Kirchhof, Sfams de Jong, F R den Hartog, A P van Alem, P E Polak, R G Tieleman, P H van der Voort, T Lenderink, A M Otten, Jssg de Jong, Y L Gu, Jglm Luermans, Mjha KruipSaj Timmer, Tac de Vries, H Ten Cate, G J Geersing, F H Rutten, M V Huisman, Mew Hemels

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Aims: To evaluate the extent and determinants of off-label non-vitamin K oral anticoagulant (NOAC) dosing in newly diagnosed Dutch AF patients.

Methods and results: In the DUTCH-AF registry, patients with newly diagnosed AF (<6 months) are prospectively enrolled. Label adherence to NOAC dosing was assessed using the European Medicines Agency labelling. Factors associated with off-label dosing were explored by multivariable logistic regression analyses. From July 2018 to November 2020, 4500 patients were registered. The mean age was 69.6 ± 10.5 years, and 41.5% were female. Of the 3252 patients in which NOAC label adherence could be assessed, underdosing and overdosing were observed in 4.2% and 2.4%, respectively. In 2916 (89.7%) patients with a full-dose NOAC recommendation, 4.6% were underdosed, with a similar distribution between NOACs. Independent determinants (with 95% confidence interval) were higher age [odds ratio (OR): 1.01 per year, 1.01-1.02], lower renal function (OR: 0.96 per ml/min/1.73 m2, 0.92-0.98), lower weight (OR: 0.98 per kg, 0.97-1.00), active malignancy (OR: 2.46, 1.19-5.09), anaemia (OR: 1.73, 1.08-2.76), and concomitant use of antiplatelets (OR: 4.93, 2.57-9.46). In the 336 (10.3%) patients with a reduced dose NOAC recommendation, 22.9% were overdosed, most often with rivaroxaban. Independent determinants were lower age (OR: 0.92 per year, 0.88-0.96) and lower renal function (OR: 0.98 per ml/min/1.73 m2, 0.96-1.00).

Conclusion: In newly diagnosed Dutch AF patients, off-label dosing of NOACs was seen in only 6.6% of patients, most often underdosing. In this study, determinants of off-label dosing were age, renal function, weight, anaemia, active malignancy, and concomitant use of antiplatelets.

Original language	English
Pages (from-to)	oeac022
Journal	European heart journal open
Volume	2
Issue number	3
DOIs	https://doi.org/10.1093/ehjopen/oeac022
Publication status	Published - May 2022

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10.1093/ehjopen/oeac022Licence: CC BY-NC

Cite this

Seelig, J., Trinks-Roerdink, E. M., Chu, G., Pisters, R., Theunissen, L., Trines, S. A., Pos, L., Kirchhof, C., de Jong, S., den Hartog, F. R., van Alem, A. P., Polak, P. E., Tieleman, R. G., van der Voort, P. H., Lenderink, T., Otten, A. M., de Jong, J., Gu, Y. L., Luermans, J., ... Hemels, M. (2022). Determinants of label non-adherence to non-vitamin K oral anticoagulants in patients with newly diagnosed atrial fibrillation. European heart journal open, 2(3), oeac022. https://doi.org/10.1093/ehjopen/oeac022

@article{85b4becaaa14446eaf790f822290f296,

title = "Determinants of label non-adherence to non-vitamin K oral anticoagulants in patients with newly diagnosed atrial fibrillation",

abstract = "Aims: To evaluate the extent and determinants of off-label non-vitamin K oral anticoagulant (NOAC) dosing in newly diagnosed Dutch AF patients.Methods and results: In the DUTCH-AF registry, patients with newly diagnosed AF (<6 months) are prospectively enrolled. Label adherence to NOAC dosing was assessed using the European Medicines Agency labelling. Factors associated with off-label dosing were explored by multivariable logistic regression analyses. From July 2018 to November 2020, 4500 patients were registered. The mean age was 69.6 ± 10.5 years, and 41.5% were female. Of the 3252 patients in which NOAC label adherence could be assessed, underdosing and overdosing were observed in 4.2% and 2.4%, respectively. In 2916 (89.7%) patients with a full-dose NOAC recommendation, 4.6% were underdosed, with a similar distribution between NOACs. Independent determinants (with 95% confidence interval) were higher age [odds ratio (OR): 1.01 per year, 1.01-1.02], lower renal function (OR: 0.96 per ml/min/1.73 m2, 0.92-0.98), lower weight (OR: 0.98 per kg, 0.97-1.00), active malignancy (OR: 2.46, 1.19-5.09), anaemia (OR: 1.73, 1.08-2.76), and concomitant use of antiplatelets (OR: 4.93, 2.57-9.46). In the 336 (10.3%) patients with a reduced dose NOAC recommendation, 22.9% were overdosed, most often with rivaroxaban. Independent determinants were lower age (OR: 0.92 per year, 0.88-0.96) and lower renal function (OR: 0.98 per ml/min/1.73 m2, 0.96-1.00).Conclusion: In newly diagnosed Dutch AF patients, off-label dosing of NOACs was seen in only 6.6% of patients, most often underdosing. In this study, determinants of off-label dosing were age, renal function, weight, anaemia, active malignancy, and concomitant use of antiplatelets.",

author = "J Seelig and Trinks-Roerdink, {E M} and G Chu and R Pisters and Ljhj Theunissen and Trines, {S A} and L Pos and Cjhj Kirchhof and {de Jong}, Sfams and {den Hartog}, {F R} and {van Alem}, {A P} and Polak, {P E} and Tieleman, {R G} and {van der Voort}, {P H} and T Lenderink and Otten, {A M} and {de Jong}, Jssg and Gu, {Y L} and Jglm Luermans and Mjha Kruip and Saj Timmer and {de Vries}, Tac and Cate, {H Ten} and Geersing, {G J} and Rutten, {F H} and Huisman, {M V} and Mew Hemels",

note = "{\textcopyright} The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.",

year = "2022",

month = may,

doi = "10.1093/ehjopen/oeac022",

language = "English",

volume = "2",

pages = "oeac022",

journal = "European heart journal open",

issn = "2752-4191",

publisher = "Oxford University Press",

number = "3",

}

Seelig, J, Trinks-Roerdink, EM, Chu, G, Pisters, R, Theunissen, L, Trines, SA, Pos, L, Kirchhof, C, de Jong, S, den Hartog, FR, van Alem, AP, Polak, PE, Tieleman, RG, van der Voort, PH, Lenderink, T, Otten, AM, de Jong, J, Gu, YL, Luermans, J, Kruip, M, Timmer, S, de Vries, T, Cate, HT, Geersing, GJ, Rutten, FH, Huisman, MV & Hemels, M 2022, 'Determinants of label non-adherence to non-vitamin K oral anticoagulants in patients with newly diagnosed atrial fibrillation', European heart journal open, vol. 2, no. 3, pp. oeac022. https://doi.org/10.1093/ehjopen/oeac022

TY - JOUR

T1 - Determinants of label non-adherence to non-vitamin K oral anticoagulants in patients with newly diagnosed atrial fibrillation

AU - Seelig, J

AU - Trinks-Roerdink, E M

AU - Chu, G

AU - Pisters, R

AU - Theunissen, Ljhj

AU - Trines, S A

AU - Pos, L

AU - Kirchhof, Cjhj

AU - de Jong, Sfams

AU - den Hartog, F R

AU - van Alem, A P

AU - Polak, P E

AU - Tieleman, R G

AU - van der Voort, P H

AU - Lenderink, T

AU - Otten, A M

AU - de Jong, Jssg

AU - Gu, Y L

AU - Luermans, Jglm

AU - Kruip, Mjha

AU - Timmer, Saj

AU - de Vries, Tac

AU - Cate, H Ten

AU - Geersing, G J

AU - Rutten, F H

AU - Huisman, M V

AU - Hemels, Mew

PY - 2022/5

Y1 - 2022/5

N2 - Aims: To evaluate the extent and determinants of off-label non-vitamin K oral anticoagulant (NOAC) dosing in newly diagnosed Dutch AF patients.Methods and results: In the DUTCH-AF registry, patients with newly diagnosed AF (<6 months) are prospectively enrolled. Label adherence to NOAC dosing was assessed using the European Medicines Agency labelling. Factors associated with off-label dosing were explored by multivariable logistic regression analyses. From July 2018 to November 2020, 4500 patients were registered. The mean age was 69.6 ± 10.5 years, and 41.5% were female. Of the 3252 patients in which NOAC label adherence could be assessed, underdosing and overdosing were observed in 4.2% and 2.4%, respectively. In 2916 (89.7%) patients with a full-dose NOAC recommendation, 4.6% were underdosed, with a similar distribution between NOACs. Independent determinants (with 95% confidence interval) were higher age [odds ratio (OR): 1.01 per year, 1.01-1.02], lower renal function (OR: 0.96 per ml/min/1.73 m2, 0.92-0.98), lower weight (OR: 0.98 per kg, 0.97-1.00), active malignancy (OR: 2.46, 1.19-5.09), anaemia (OR: 1.73, 1.08-2.76), and concomitant use of antiplatelets (OR: 4.93, 2.57-9.46). In the 336 (10.3%) patients with a reduced dose NOAC recommendation, 22.9% were overdosed, most often with rivaroxaban. Independent determinants were lower age (OR: 0.92 per year, 0.88-0.96) and lower renal function (OR: 0.98 per ml/min/1.73 m2, 0.96-1.00).Conclusion: In newly diagnosed Dutch AF patients, off-label dosing of NOACs was seen in only 6.6% of patients, most often underdosing. In this study, determinants of off-label dosing were age, renal function, weight, anaemia, active malignancy, and concomitant use of antiplatelets.

AB - Aims: To evaluate the extent and determinants of off-label non-vitamin K oral anticoagulant (NOAC) dosing in newly diagnosed Dutch AF patients.Methods and results: In the DUTCH-AF registry, patients with newly diagnosed AF (<6 months) are prospectively enrolled. Label adherence to NOAC dosing was assessed using the European Medicines Agency labelling. Factors associated with off-label dosing were explored by multivariable logistic regression analyses. From July 2018 to November 2020, 4500 patients were registered. The mean age was 69.6 ± 10.5 years, and 41.5% were female. Of the 3252 patients in which NOAC label adherence could be assessed, underdosing and overdosing were observed in 4.2% and 2.4%, respectively. In 2916 (89.7%) patients with a full-dose NOAC recommendation, 4.6% were underdosed, with a similar distribution between NOACs. Independent determinants (with 95% confidence interval) were higher age [odds ratio (OR): 1.01 per year, 1.01-1.02], lower renal function (OR: 0.96 per ml/min/1.73 m2, 0.92-0.98), lower weight (OR: 0.98 per kg, 0.97-1.00), active malignancy (OR: 2.46, 1.19-5.09), anaemia (OR: 1.73, 1.08-2.76), and concomitant use of antiplatelets (OR: 4.93, 2.57-9.46). In the 336 (10.3%) patients with a reduced dose NOAC recommendation, 22.9% were overdosed, most often with rivaroxaban. Independent determinants were lower age (OR: 0.92 per year, 0.88-0.96) and lower renal function (OR: 0.98 per ml/min/1.73 m2, 0.96-1.00).Conclusion: In newly diagnosed Dutch AF patients, off-label dosing of NOACs was seen in only 6.6% of patients, most often underdosing. In this study, determinants of off-label dosing were age, renal function, weight, anaemia, active malignancy, and concomitant use of antiplatelets.

U2 - 10.1093/ehjopen/oeac022

DO - 10.1093/ehjopen/oeac022

M3 - Article

C2 - 35919339

SN - 2752-4191

VL - 2

SP - oeac022

JO - European heart journal open

JF - European heart journal open

IS - 3

ER -