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Effectiveness, safety and costs of thromboembolic prevention in patients with non-valvular atrial fibrillation: phase I ESC-FA protocol study and baseline characteristics of a cohort from a primary care electronic database
  1. Maria Giner-Soriano1,2,
  2. Cristina Vedia Urgell2,3,
  3. Albert Roso-Llorach1,2,
  4. Rosa Morros1,2,
  5. Dolors Capellà4,
  6. Xavier Castells4,
  7. Ignacio Ferreira-González5,
  8. Amelia Troncoso Mariño6,
  9. Eduard Diògene7,
  10. Josep Mª Elorza8,
  11. Marc Casajuana1,2,
  12. Bonaventura Bolíbar1,2,
  13. Concepció Violan1,2
  1. 1Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain
  2. 2Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain
  3. 3Unitat de farmàcia, Servei d'Atenció Primària Barcelonès Nord i Maresme, Institut Català de la Salut, Badalona, Spain
  4. 4Translab Research Group, Unitat de Farmacologia Clínica, Departament de Ciències Mèdiques, Facultat de Medicina, UdG, Girona, Spain
  5. 5Unidad de Epidemiología del Servicio de Cardiología, Hospital Vall d'Hebron y CIBER de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain
  6. 6Unitat de Coordinació i Estratègia del Medicament, Institut Català de la Salut, Barcelona, Spain
  7. 7Servei de Farmacologia, Hospital Vall d'Hebron, Barcelona, Spain
  8. 8System for the Improvement of Research in Primary Care (SIDIAP), Barcelona, Spain
  1. Correspondence to Maria Giner-Soriano; mginer{at}idiapjgol.info

Abstract

Purpose Atrial fibrillation is the most common arrhythmia. Its management aims to reduce symptoms and to prevent complications through rate and rhythm control, management of concomitant cardiac diseases and prevention of related complications, mainly stroke. The main objective of Effectiveness, Safety and Costs in Atrial Fibrillation (ESC-FA) study is to analyse the drugs used for the management of the disease in real-use conditions, particularly the antithrombotic agents for stroke prevention. The aim of this work is to present the study protocol of phase I of the ESC-FA study and the baseline characteristics of newly diagnosed patients with atrial fibrillation in Catalonia, Spain.

Participants The data source is System for the Improvement of Research in Primary Care (SIDIAP) database. The population included are all patients with non-valvular atrial fibrillation diagnosis registered in the electronic health records during 2007–2012.

Findings to date A total of 22 585 patients with non-valvular atrial fibrillation were included in the baseline description. Their mean age was 72.8 years and 51.6% were men. The most commonly prescribed antithrombotics were vitamin K antagonists (40.1% of patients) and platelet aggregation inhibitors (32.9%); 25.3% had not been prescribed antithrombotic treatment. Age, gender, comorbidities and co-medication at baseline were similar to those reported for previous studies.

Future plans The next phase in the ESC-FA study will involve assessing the effectiveness and safety of antithrombotic treatments, analysing stroke events and bleeding episodes’ rates in our patients (rest of phase I), describing the current management of the disease and its costs in our setting, and assessing how the introduction of new oral anticoagulants changes the stroke prevention in non-valvular atrial fibrillation.

  • atrial fibrillation
  • electronic health records
  • platelet aggregation inhibitors

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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