title: Effectiveness and safety of dabigatran versus acenocoumarol in 'real-world' patients with atrial fibrillation.
abstract: OBJECTIVE
  Randomized trials showed non-inferior or superior results of the non-vitamin-K-antagonist oral anticoagulants (NOACs) compared with warfarin. The aim of this study was to assess the effectiveness and safety of dabigatran (direct thrombin inhibitor) vs. acenocoumarol (vitamin K antagonist) in patients with atrial fibrillation (AF) in daily clinical practice.
  
  
  RESULTS
  In this observational study, we evaluated all consecutive patients who started anticoagulation because of AF in our outpatient clinic from 2010 to 2013. Data were collected from electronic patient charts. Primary outcomes were stroke or systemic embolism and major bleeding. Propensity score matching was applied to address the non-randomized design. In total, 920 consecutive AF patients were enrolled (442 dabigatran, 478 acenocoumarol), of which 2 × 383 were available for analysis after propensity score matching. Mean follow-up duration was 1.5 ± 0.56 year. The mean calculated stroke risk according to the CHA2DS2-VASc score was 3.5%/year in dabigatran vs. 3.7%/year acenocoumarol-treated patients. The actual incidence rate of stroke or systemic embolism was 0.8%/year [95% confidence interval (CI): 0.2-2.1] vs. 1.0%/year (95% CI: 0.4-2.1), respectively. Multivariable analysis confirmed this lower but non-significant risk in dabigatran vs. acenocoumarol after adjustment for the CHA2DS2-VASc score [hazard ratio (HR)dabigatran = 0.72, 95% CI: 0.20-2.63, P = 0.61]. According to the HAS-BLED score, the mean calculated bleeding risk was 1.7%/year in both groups. Actual incidence rate of major bleeding was 2.1%/year (95% CI: 1.0-3.8) in the dabigatran vs. 4.3%/year (95% CI: 2.9-6.2) in acenocoumarol. This over 50% reduction remained significant after adjustment for the HAS-BLED score (HRdabigatran = 0.45, 95% CI: 0.22-0.93, P = 0.031).
  
  
  CONCLUSIONS
  In 'real-world' patients with AF, dabigatran appears to be as effective, but significantly safer than acenocoumarol.
authors: University of Groningen, Groningen, The Netherlands Department of Cardiology, Martini Hospital Groningen, Groningen, The Netherlands.
authors: Jennie
authors: J
authors: Korenstra
authors: Department of Cardiology, Martini Hospital Groningen, Groningen, The Netherlands.
authors: E Petra J
authors: EP
authors: Wijtvliet
authors: Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors: Nic J G M
authors: NJ
authors: Veeger
authors: Department of Cardiology, Martini Hospital Groningen, Groningen, The Netherlands.
authors: Christiane A
authors: CA
authors: Geluk
authors: Department of Cardiology, Martini Hospital Groningen, Groningen, The Netherlands.
authors: G Louis
authors: GL
authors: Bartels
authors: Department of Cardiology, Martini Hospital Groningen, Groningen, The Netherlands.
authors: Jan L
authors: JL
authors: Posma
authors: Certe, Thrombosis Service and Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.
authors: Margriet
authors: M
authors: Piersma-Wichers
authors: Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.
authors: Isabelle C
authors: IC
authors: Van Gelder
authors: Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.
authors: Michiel
authors: M
authors: Rienstra
authors: Department of Cardiology, Martini Hospital Groningen, Groningen, The Netherlands Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands r.tieleman@mzh.nl.
authors: Robert G
authors: RG
authors: Tieleman
mesh_terms: D000074:Acenocoumarol / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D001777:Blood Coagulation / Q000187:drug effects*; D016009:Chi-Square Distribution; D000069604:Dabigatran / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D016903:Drug Monitoring / Q000379:methods; D057286:Electronic Health Records; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D019934:International Normalized Ratio; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009426:Netherlands / Q000453:epidemiology; D061214:Patient Safety; D057216:Propensity Score; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D012307:Risk Factors; D020521:Stroke / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D000069604:Dabigatran; D000074:Acenocoumarol
keywords: Acenocoumarol; Anticoagulation; Atrial fibrillation; Bleeding; Dabigatran; Stroke