title: Efficacy and safety of novel oral anticoagulants in clinical practice: a report from three centers in Sweden.
abstract: BACKGROUND
  In clinical trials new oral anticoagulants (NOAC) have proved to be as effective as warfarin for thromboprophylaxis in atrial fibrillation. The aim of this study was to evaluate the efficacy and safety of these drugs in clinical practise.
  
  
  RESULTS
  All patients treated with new oral anticoagulants at Skåne University hospital and Halland County Hospital Halmstad between 2009 and September 2013 was identified in the Swedish national quality registry for atrial fibrillation and anticoagulation (AuriculA). Medical records were reviewed to identify thromboembolism and major bleeding and compared to a warfarin cohort with a time in therapeutic range (TTR) of 76%. There were 826 patients, mean age 70.6, follow up 591 years, with atrial fibrillation treated with NOAC. Dabigatran was the initial drug in 79% of the cohort. The incidences of ischemic stroke/ TIA and major bleeding were 1.9 (95% CI; 1.0-3.2) and 2.0 (95% CI; 1.1-3.5) per 100 patient-years respectively. The corresponding incidences for warfarin were 1.5 (95% CI; 1.0-2.2) and 2.5 (95% CI; 1.8-3.3), with no statistical significance between the groups. Two subdural hematomas occurred 0.4 (95% CI; 0.06-1.1) per 100 patient-years. Mean age of patients with complications was 77.9 (±5.9) and 69.3 (±11.3) for those without (p < 0.001). The discontinuation rate was 6.5% and 1.7% was due to dyspepsia for dabigatran, lower than the RE-LY trial.
  
  
  CONCLUSIONS
  This study, largely based on dabigatran shows that treatment is efficient and safe in everyday clinical practice and not significantly different compared to a warfarin cohort with tight anticoagulation control.
authors.affiliation: Department of Clinical Sciences, Lund University, Malmö, Sweden.|Department of Cardiology, Skåne University Hospital, Malmö, Sweden.
authors.forename: Ashkan
authors.initials: A
authors.lastname: Labaf
authors.affiliation: Department of Medicine, Hallands Hospital, Halmstad, Sweden.
authors.forename: Martin
authors.initials: M
authors.lastname: Carlwe
authors.affiliation: Department of Clinical Sciences, Lund University, Malmö, Sweden.|Department of Coagulation disorders, Skåne University Hospital, 205 02 Malmö, Sweden.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Svensson
keywords: Atrial fibrillation; Dabigatran; Major bleeding; Novel oral anticoagulants; Thromboembolism