Stroke Prophylaxis of AF-patients: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to VKA

Study Overview
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Brief Summary
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The central questions of the study can be summarized as follows: What stroke / death rates are the result of the use of the following treatment strategies: no anticoagulation with vitamin-k-antagonists (VKAs) or novel oral anticoagulants (NOACs), anticoagulation with VKAs and anticoagulation with NOACs (all). What other thromboembolic complication rates resulting from the use of these treatment strategies? What heavy bleeding rates resulting from the defined management strategies? The analysis is based on a data set of patients with atrial fibrillation (AF)(01/01/2010 - 30/06/2014). 2010 is used as the reference period and 01/01/2011-30/06/2013 as the inclusion period. The minimum observation time per patient is 12 months. Used is a data base of the AOK PLUS as well as the AOK Baden-Württemberg and AOK Bayern. The aim of the study is to compare clinical outcomes between the different treatment strategies (frequency of events and time to first event). The influence of alternative treatment strategies is measured on the basis of three different methodological approaches: unadjusted comparison of event council and time to first event between the defined patient groups; matched-pair comparison (propensity score matching) between the different groups of patients (treatment strategies) and multivariate analysis using time to event (Cox proportional hazards model) as the dependent variable.

Official Title
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Stroke Prophylaxis of Patients With Atrial Fibrillation: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to Vitamin-k-antagonists Based on an Analysis of German Claims Data

Conditions
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Atrial Fibrillation, Stroke Prophylaxis

Intervention / Treatment
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* Drug: vitamin-k-antagonists
* Drug: Novel oral anticoagulants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: one inpatient or two outpatient confirmed diagnosis of atrial fibrillation in two different quarters Continuously insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg Exclusion Criteria: Age < 18 years Maximum possible observational period < 12 months (exception: death)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No anticoagulation with VKA/NOAC<br>No prescriptions of vitamin-k-antagonists/novel anticoagulants in all observational period; No prescriptions of low molecular weight heparins/Clopidogrel during observation period to the extent of more than 30 days. | |
| Anticoagulation with vitamin-k-antagonists<br>The patient should be treated stable during the observation period with vitamin-k-antagonists (at least one prescription per half-year). The patient should be not been around on other anticoagulants during the observation period. This means that no prescriptions of novel anticoagulants and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year. | Drug: vitamin-k-antagonists<br> <br> |
| Anticoagulation with novel oral anticoagulants<br>The patient should be treated stable during the observation period with a novel anticoagulant (at least one prescription per half-year). This means that no vitamin-k-antagonists prescriptions and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year from the start of the observation period. | Drug: Novel oral anticoagulants<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 01/01/2011-30/06/2014; at least 12 months; up to 40 months | 
| Transient ischemic attack |  | 01/01/2011-30/06/2014; at least 12 months; up to 40 months | 
| Ischemic stroke |  | 01/01/2011-30/06/2014; at least 12 months; up to 40 months | 
| Hemorrhagic stroke |  | 01/01/2011-30/06/2014; at least 12 months; up to 40 months | 
| Heavy bleeding |  | 01/01/2011-30/06/2014; at least 12 months; up to 40 months |