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Real-world effectiveness and safety of oral anticoagulation strategies in atrial fibrillation: a cohort study based on a German claims dataset
- Source :
- Pragmatic and Observational Research
- Publication Year :
- 2018
- Publisher :
- Dove Medical Press, 2018.
-
Abstract
- 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 clinicaltrials.gov (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
- Subjects :
- medicine.medical_specialty
Arterial embolism
Proportional hazards model
business.industry
Hazard ratio
VKA
Atrial fibrillation
AF
medicine.disease
Internal medicine
Cohort
medicine
cohort study
atrial fibrillation
NOAC
Medical prescription
business
anticoagulation
Pragmatic and Observational Research
Oral anticoagulation
Cohort study
Original Research
Subjects
Details
- Language :
- English
- ISSN :
- 11797266
- Volume :
- 9
- Database :
- OpenAIRE
- Journal :
- Pragmatic and Observational Research
- Accession number :
- edsair.doi.dedup.....ce5ec01b280cd95a5a0f473a96892e7b