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, L J H J Theunissen, S A Trines, L Pos, C J H J Kirchhof, S F A M S 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, J S S G de Jong, Y L Gu, J G L M Luermans, M J H A KruipS A J Timmer, T A C de Vries, H Ten Cate, G J Geersing, F H Rutten, M V Huisman, M E W Hemels

Research output: Contribution to journalArticleAcademicpeer-review

1 Downloads (Pure)


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 languageEnglish
Article numberoeac022
JournalEuropean heart journal open
Issue number3
Publication statusPublished - May 2022

Bibliographical note

This work was supported by a research grant from The Netherlands Organization for Health Research and Development (ZonMW) (project numbers 848050006, 848050007).

© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.


Dive into the research topics of 'Determinants of label non-adherence to non-vitamin K oral anticoagulants in patients with newly diagnosed atrial fibrillation'. Together they form a unique fingerprint.

Cite this