The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)

Study Overview
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Brief Summary
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Preliminary data suggest that: a different risk of mortality, as assessed by the Multidimensional Prognostic Indices (MPI), may influence the anticoagulant prescription in older subjects with Atrial Fibrillation (AF); the presence of multidimensional impairment, disability and multi-morbidities are usually not included in the decision algorithm of the more appropriate treatments in older patients with AF; considering the prognostic information, as calculated by the MPI, can be useful to physicians in identifying older patients with AF that can benefit from anticoagulant treatment in term of increased survival.

Detailed Description
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The main objective of this observational study is to evaluate in a real world population of older hospitalized patients with AF, the clinical benefit/risk ratio of the anticoagulant treatments in terms of: mortality (all-cause and vascular mortality); thromboembolic events, i.e. stroke, systemic embolism; bleeding side-effects, especially intracranial and gastrointestinal bleeding Secondary objective of the study is to evaluate whether a different prognostic profile, as determined by the MPI, is associated with 1) different kind of treatments for AF (no treatment vs anticoagulants, i.e. Vitamin K Antagonists (VKA) or novel oral anticoagulant (NOACs); and 2) differences in the main outcomes (i.e. mortality, major thromboembolic events and side effects including bleeding events).

Official Title
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Evaluating the Efficacy and Risks of Anticoagulant Treatments in Multimorbid Frail Older Subjects With Atrial Fibrillation. The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This is an observational study in which all consecutive patients admitted to the Geriatrics Units involved in the project will be screened for inclusion. The inclusion criteria are: patients of both genders, aged 65 years and older admitted to hospital for acute diseases or a relapse of chronic diseases with a documented diagnosis of non valvular AF who are willing to participate in the survey and give their informed consent Exclusion Criteria: age less than 65 years patients who have not provided informed consent

Ages Eligible for Study
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Minimum Age: 65 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality and vascular mortality | Vascular mortality is defined as: stroke, embolism, myocardial infarction | 12 months | 
| thromboembolic events, | stroke and/or systemic embolism | 12 months | 
| bleeding side-effects | major intracranial and gastrointestinal bleeding. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular-related hospitalization rates | stroke and/or systemic embolism | 12 months | 
| bleeding-related hospitalization rates | intracranial and gastrointestinal bleeding | 12 months | 
| MPI value and different mortality risk class | mild, moderate, severe | 12 months | 
| presence/absence of anticoagulant treatments | presence of anticoagulant treatments | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulant Treatments, Multidimensional Prognostic Index (MPI), Comprehensive Geriatric Assessment (CGA), Frailty, Elderly, Atrial Fibrillation