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Dabigatran and vitamin K antagonists’ use in naïve patients with non-valvular atrial fibrillation: a cross-sectional study of primary care-based electronic health records

European Journal of Clinical Pharmacology volume 73, pages 1323–1330 (2017)Cite this article

Abstract

Purpose

The purpose of this study was to characterize the profile of patients with non-valvular atrial fibrillation who start an anticoagulant treatment after diagnosis with dabigatran and compare it with those who start with vitamin K antagonists (VKAs).

Methods

We analysed primary health care-based electronic health records data from 15,075 people with new diagnosis of atrial fibrillation who initiated treatment with dabigatran or VKA spanning 2011–2013. Logistic regression analysis for determination of factors associated with initiation of dabigatran was performed.

Results

We identified 14,266 (94.6%) people who initiated VKA and 809 (5.4%) who initiated dabigatran. Mean age of people treated with dabigatran was lower than in VKA patients (73.7 vs 75.5 years, p < 0.001). People (90.5%) in VKA group and 83.6% in the dabigatran group had a high risk of stroke, according to CHA2DS2VASc score. There was higher proportion of people with hypertension, diabetes mellitus, dyslipidaemia, and chronic kidney disease among people treated with VKA. The proportion of people with a history of cerebral haemorrhage and stroke was higher among dabigatran patients compared with VKA patients (1.4 vs 0.6%, p = 0.015 and 14.0% vs 10.8%, p = 0.006, respectively). Multivariable logistic model showed that treatment with dabigatran was associated with male sex, history of stroke and Mortalidad en áreas pequeñas Españolas y Desigualdades Socioeconómicas index.

Conclusions

Most patients recently diagnosed with non-valvular atrial fibrillation initiated treatment with VKA. Primary healthcare patients with non-valvular atrial fibrillation initiating dabigatran are younger, had a lower risk of stroke or bleeding, fewer comorbidity and more history of stroke and intracranial haemorrhage compared to those who were initiated on VKA.

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Author information

Affiliations

  1. Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain

    Bogdan Vlacho, Maria Giner-Soriano, Edurne Zabaleta-del-Olmo, Albert Roso-Llorach, Ana García-Sangenís & Rosa Morros-Pedrós

  2. Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Valles, Spain

    Bogdan Vlacho, Maria Giner-Soriano, Edurne Zabaleta-del-Olmo, Albert Roso-Llorach, Ana García-Sangenís & Rosa Morros-Pedrós

  3. Institut Català de la Salut, Generalitat de Catalunya, Barcelona, Spain

    Maria Giner-Soriano, Edurne Zabaleta-del-Olmo & Rosa Morros-Pedrós

  4. Faculty of Nursing, Universitat de Girona, Girona, Spain

    Edurne Zabaleta-del-Olmo

  5. UICEC IDIAP Jordi Gol, Plataforma SCReN, Barcelona, Spain

    Rosa Morros-Pedrós

Authors
  1. Bogdan Vlacho
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  2. Maria Giner-Soriano
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  3. Edurne Zabaleta-del-Olmo
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  4. Albert Roso-Llorach
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  5. Ana García-Sangenís
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  6. Rosa Morros-Pedrós
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Corresponding author

Correspondence to Maria Giner-Soriano.

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Funding

“ESC-FA study, study in various phases on the effectiveness, safety and cost of thromboembolic prevention in patients with non-valvular atrial fibrillation” received funding from the Ministry of Health, Social Policy and Equality (Spanish Government) through the 2011 Grants for Independent Clinical Research (reference EC11-251).

Ethical approval

The present study follows national and international regulations: Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects and good research practice principles and guidelines. The IDIAP Jordi Gol Clinical Research Ethics Committee, the reference institution for research in PHC of the ICS, approved the study protocol. Regarding the data contained in the databases and according to Spanish legislation about confidentiality and data protection (Ley Orgánica 15/1999 de 13 de diciembre de Protección de Datos de Carácter Personal), data included in SIDIAP are always anonymized. Thus, it is not necessary to ask for informed consent to the participants. For the linkage with CMBD-AH database (or other databases), SIDIAP uses a “trusted third party” in order to ensure confidentiality when linking both data sources. This third party has no access to clinical information, only to codes and IDs.

Conflict of interest

The authors declare that they have no conflict of interest.

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Vlacho, B., Giner-Soriano, M., Zabaleta-del-Olmo, E. et al. Dabigatran and vitamin K antagonists’ use in naïve patients with non-valvular atrial fibrillation: a cross-sectional study of primary care-based electronic health records. Eur J Clin Pharmacol 73, 1323–1330 (2017). https://doi.org/10.1007/s00228-017-2305-4

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  • DOI: https://doi.org/10.1007/s00228-017-2305-4

Keywords

  • Atrial fibrillation
  • Dabigatran
  • Electronic health records
  • Primary health care
  • Stroke
  • Vitamin K antagonists