title: 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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  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.
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain.
authors.forename: Maria
authors.identifier: http://orcid.org/0000-0003-3750-9233
authors.initials: M
authors.lastname: Giner-Soriano
authors.affiliation: Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain Unitat de farmàcia, Servei d'Atenció Primària Barcelonès Nord i Maresme, Institut Català de la Salut, Badalona, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Vedia Urgell
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain.
authors.forename: Albert
authors.initials: A
authors.lastname: Roso-Llorach
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: Morros
authors.affiliation: Translab Research Group, Unitat de Farmacologia Clínica, Departament de Ciències Mèdiques, Facultat de Medicina, UdG, Girona, Spain.
authors.forename: Dolors
authors.initials: D
authors.lastname: Capellà
authors.affiliation: Translab Research Group, Unitat de Farmacologia Clínica, Departament de Ciències Mèdiques, Facultat de Medicina, UdG, Girona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Castells
authors.affiliation: Unidad de Epidemiología del Servicio de Cardiología, Hospital Vall d'Hebron y CIBER de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Ferreira-González
authors.affiliation: Unitat de Coordinació i Estratègia del Medicament, Institut Català de la Salut, Barcelona, Spain.
authors.forename: Amelia
authors.initials: A
authors.lastname: Troncoso Mariño
authors.affiliation: Servei de Farmacologia, Hospital Vall d'Hebron, Barcelona, Spain.
authors.forename: Eduard
authors.initials: E
authors.lastname: Diògene
authors.affiliation: System for the Improvement of Research in Primary Care (SIDIAP), Barcelona, Spain.
authors.forename: Josep M
authors.initials: JM
authors.lastname: Elorza
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain.
authors.forename: Marc
authors.initials: M
authors.lastname: Casajuana
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain.
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Bolíbar
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain.
authors.forename: Concepció
authors.initials: C
authors.lastname: Violan
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D001281:Atrial Fibrillation / Q000150:complications; D004359:Drug Therapy, Combination; D057286:Electronic Health Records; D006470:Hemorrhage / Q000139:chemically induced; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D020521:Stroke / Q000517:prevention & control; D013923:Thromboembolism / Q000517:prevention & control; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors; D017321:Clinical Trials, Phase I as Topic; D064887:Observational Studies as Topic
chemical_list: D010975:Platelet Aggregation Inhibitors; D014812:Vitamin K
keywords: atrial fibrillation; electronic health records; platelet aggregation inhibitors
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