Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)

Study Overview
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Brief Summary
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The aim of FINACAF study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among AF patients. The study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the Finnish health care registers.

Detailed Description
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Atrial fibrillation (AF) is the most common sustained arrhythmia, its prevalence increases with age, and it presents with a wide spectrum of symptoms and severity. It has been estimated that number of AF patients is about 150 000 in Finland, and this number will be increased at least two-fold until year 2050. The aim of this study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among AF patients. An important part of the study is also the assessment of cost effectiveness of different OAC therapies. The risks mentioned above are separately evaluated with different management levels of warfarin therapy as well as with different NOACs and in patients without OAC treatment. The study population is also characterized according to co-morbidity, interactive medications and antiarhythmic drugs in use. The study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the Finnish health care registers. The study cohort consists of patients from six hospital district areas having a diagnosis of AF. The catchment population of these six districts is about 3.5 million; 64 % of the total Finnish population 5.5 million. The study is register-based and patients will not be contacted in any phase of the study. Thus, no patient consents will be needed according to Finnish legislation. All patient data handled by the researchers will anonymous, ensuring full data protection of the patients.

Official Title
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Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has an International Classification of Diseases (ICD-10 version 10) diagnosis code I48 for AF during 1.1.2004-31.12.2018 in any of the used registries Exclusion Criteria: No ICD-10 I48 diagnose in any of the study registries. Subjects with age below 18 years at index date Patients with permanent residence in Finland less than 12 months prior to index date.

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 |
| --- | --- |
| FinACAF cohort<br>The study cohort consists of all patients with AF diagnosis (ICD-10 I48) living in Finland during 1.1.2004-31.12.2018. The study cohort is obtained from data of Finnish national registries. Patients with permanent residence in Finland less than 12 months prior to index date and patients with age below 18 years at index date are excluded from the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All-cause, stroke, myocardial infarction,systemic thromboembolic events, bleeding events | Follow-up period 1/2004-12/2018 | 
| Bleeding events | Intracranial hemorrage, Gastrointestinal hemorrage, other major bleeding events | Follow-up period 1/2004-12/2018 | 
| Ischemic Stroke | ICD-10: I63, I64, I693-I698, G45 | Follow-up period 1/2004-12/2018 | 
| Myocardial infarction | ICD-10: I21, I22 | Follow-up period 1/2004-12/2018 | 
| Systemic Thromboembolism | Other than stroke or myocardial infarction | Follow-up period 1/2004-12/2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia | Decrement of haemoglobin during follow-up period. Detailed description available in Statistical Analysis plan under secondary objectives. | Follow-up period 1/2004-12/2018 | 
| Renal failure | Time to renal impairment is defined as the time from index date to time when serum creatinine level is under the reference value. | Follow-up period 1/2004-12/2018 | 
| Dementia | Time to dementia diagnosis in patients without pre-existing dementia, ICD: F00,F01, F02, F03 | 1/2004-12/2018 | 
| Healthcare Service costs | The Diagnosis-Related Groups (DRG) are based on the Finnish version of the Nordic Classification of Surgical Procedures codes for diagnostic and treatment procedures, and the respective Nordic Diagnosis-Related Groups patient classifications. Respectively, the patient-level data for primary care (with diagnosis and activity information) are grouped using the Ambulatory and Primary Care-Related Patient Groups (APR) grouper, a grouping system equivalent to DRG used in hospital care. The detailed description available in Statistical Analysis plan under secondary objectives. | 1/2004-12/2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Anticoagulation therapy, Warfarin, NOAC, DOAC, Novel oral anticoagulants, FinACAF, Finland, AF