Back to Journals » Pragmatic and Observational Research » Volume 9

Real-world effectiveness and safety of oral anticoagulation strategies in atrial fibrillation: a cohort study based on a German claims dataset

Authors Mueller S, Groth A, Spitzer SG, Schramm A, Pfaff A, Maywald U

Received 9 November 2017

Accepted for publication 15 February 2018

Published 1 May 2018 Volume 2018:9 Pages 1—10


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Professor David Price

Sabrina Mueller,1 Antje Groth,1 Stefan G Spitzer,2,3 Anja Schramm,4 Andreas Pfaff,5 Ulf Maywald6

1Institute for Pharmacoeconomics and Medication Logistics, University of Wismar, Wismar, Germany; 2Praxisklinik Herz und Gefäße Dresden, Academic Educational Practice Clinic, TU Dresden, Dresden, Germany; 3Institute of Medical Technology, Brandenburg University of Technology Cottbus–Senftenberg, Senftenberg, Germany; 4AOK Bayern, Regensburg, Germany; 5AOK Baden-Württemberg, Stuttgart, Germany; 6AOK PLUS, Dresden, Germany

Objective: To compare the real-world effectiveness and safety of non-vitamin-K-antagonist oral anticoagulant (NOAC) treatment in atrial fibrillation (AF) patients with a vitamin-K-antagonist (VKA)-based treatment.
Methods: This was a retrospective analysis of an anonymized claims dataset from 3 German health insurance funds covering the period from January 01, 2010 to June 30, 2014, with a minimum observation time of 12 months. All continuously insured patients with at least 2 outpatient AF diagnoses and/or 1 inpatient respective diagnosis who received at least 1 outpatient prescription of a NOAC or VKA were included.
Outcomes and measures: Death, ischemic strokes (IS), non-specified strokes, transient ischemic attacks (TIAs), myocardial infarctions (MIs), arterial embolism (AE), hemorrhagic strokes, severe bleedings, and composite outcomes. Main comparisons were done based on propensity score-matched (PSM) cohorts. Results were reported as incidence rate ratios and hazard ratios (HRs).
Results: We assigned 37,439 AF patients to each PSM cohort (NOAC cohort: mean age 78.2 years, mean CHA2DS2VASc score 2.96, mean follow-up 348.5 days; VKA cohort: mean age 78.2 years, mean CHA2DS2VASc 2.95, mean follow-up 365.5 days). NOAC exposure was associated with significantly higher incidence rate ratios; 95% CI/HRs; 95% CI for the following outcomes: death (1.22; 1.17–1.28/1.22; 1.17–1.28), IS (1.90; 1.69–2.15/1.92; 1.69–2.19), non-specified strokes (2.04; 1.16–3.70/1.93; 1.13–3.32), TIAs (1.52; 1.29–1.79/1.44; 1.21–1.70), MIs (1.26; 1.10–1.15/1.31; 1.13–1.52), AE (1.75; 1.32–2.32/1.81; 1.36–2.34) and severe bleeding (1.92; 1.71–2.15/1.95; 1.74–2.20). Multivariable Cox regression analyses and additional sensitivity analysis, including analysis of PSM-matched NOAC/VKA treatment-naive patients, only confirmed the above results. The study was documented under (NCT02657616).
Conclusion and relevance: A VKA therapy seems to be more effective and safer than a NOAC therapy in a real-world cohort of German AF patients.

Keywords: atrial fibrillation, AF, anticoagulation, NOAC, VKA, cohort study

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]