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Population-based cohort study of warfarin-treated patients with atrial fibrillation: incidence of cardiovascular and bleeding outcomes
  1. Arlene M Gallagher1,2,
  2. Tjeerd P van Staa1,2,
  3. Tarita Murray-Thomas1,
  4. Nils Schoof3,
  5. Andreas Clemens4,5,
  6. Diana Ackermann3,
  7. Dorothee B Bartels3,6
  1. 1Clinical Practice Research Datalink, London, UK
  2. 2Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands
  3. 3Corp Department Global Epidemiology, Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany
  4. 4Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
  5. 5Center for Thrombosis and Hemostasis, Johannes Gutenberg University, Medical Center, Mainz, Germany
  6. 6Hannover Medical School, Hannover, Germany
  1. Correspondence to Arlene Gallagher; arlene.gallagher{at}


Objectives Atrial fibrillation (AF) is the most common cardiac rhythm disorder with a significant health burden. The aim of this study was to characterise patients with recently diagnosed AF and to estimate the rates of comorbidities and outcome events requiring hospitalisation in routine clinical practice.

Design Pharmacoepidemiological cohort study using observational data.

Methods/setting This study included 16 513 patients with a first diagnosis of AF between 1 January 2005 and 28 February 2010 (newly diagnosed patients) using data from the UK Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) and the Office for National Statistics mortality data. Exposure was stratified by vitamin K antagonist (VKA) exposure (non-use, current, recent and past exposure) based on prescriptions and/or international normalised ratio measurements, and followed for outcome events of interest based on diagnosis codes in the databases, that is, vascular outcomes, bleeding events and others. The main focus of the study was on outcome events requiring hospitalisation using the HES data.

Results The incidence of vascular outcome hospitalisations (myocardial infarction (MI), stroke or systemic arterial peripheral embolism) was 3.8 (95% CI 3.5 to 4.0)/100 patient-years. The incidence of stroke was 0.9 (0.8 to 1.1) during current VKA exposure, 2.2 (1.6 to 2.9) for recent, 2.4 (1.9 to 2.9) for past and 3.4 (3.1 to 3.7) during non-use. MI incidence was 0.7 (0.6 to 0.9) for current VKA exposure, 0.7 (0.4 to 1.2) for recent, 1.1 (0.8 to 1.5) for past and 1.9 (1.7 to 2.1) during non-use. The incidence of bleeding event hospitalisations was 3.8 (3.4 to 4.2) for current VKA exposure, 4.5 (3.7 to 5.5) for recent, 2.7 (2.2 to 3.3) for past and 2.9 (2.6 to 3.2) during non-use; 38% of intracranial bleeds and 6% of gastrointestinal bleeds were fatal.

Conclusions This population-based study from recent years provides a comprehensive characterisation of newly diagnosed patients with AF and incidence estimates of common outcomes with a focus on hospitalised events stratified by VKA exposure. This study will help to place future data on new oral anticoagulants into perspective.

  • Cardiology

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