High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France

Study Overview
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Brief Summary
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This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns, and safety and effectiveness outcomes in patients with NVAF with high risk of gastrointestinal bleed who initiate anticoagulant treatment with a Vitamin-K Antagonists (VKAs) or direct-acting oral anticoagulants (DOACs).

Official Title
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Anticoagulant Treatment Patterns and Outcomes Among Non-valvular Atrial Fibrillation Patients With High Risk of Gastrointestinal Bleeding in France: a Retrospective Cohort Analysis Using SNDS Database

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Apixaban
* Drug: Rivaroxaban
* Drug: Dabigatran
* Drug: Vitamin K antagonist (VKA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients covered by the French national health insurance general scheme With at least one reimbursement of AC treatment (apixaban, rivaroxaban, dabigatran, or VKAs) Aged ≥18 years as of the index date With a diagnosis of atrial fibrillation (AF) prior to or on the index date With at least one risk factor for gastrointestinal bleeding Exclusion Criteria: Patients with different types of AC treatment at the index date Patients with a diagnosis or procedure code indicative of rheumatic mitral valvular heart disease or valve replacement procedure Individuals with a diagnosis of VTE during the 12 months prior to or on the 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 |
| --- | --- |
| NVAF High GI bleed risk<br>NVAF patients with a high risk of gastrointestinal bleeding | Drug: Apixaban<br>* Anticoagulant<br>Drug: Rivaroxaban<br>* Anticoagulant<br>Drug: Dabigatran<br>* Anticoagulant<br>Drug: Vitamin K antagonist (VKA)<br>* Anticoagulant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding leading to hospitalization | The follow-up period will be from the index date to death or end of study (31 December 2019). For the comparative analyses of clinical outcomes the follow-up period will be from the day after index date to the earliest of an outcome of interest (separately for each outcome); treatment discontinuation, treatment switch, death, or end of study. | 2016-2019 | 
| Stroke | The follow-up period will be from the index date to death or end of study (31 December 2019). For the comparative analyses of clinical outcomes the follow-up period will be from the index date to the earliest of an outcome of interest (separately for each outcome); treatment discontinuation, treatment switch, death, or end of study. | 2016-2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-Coagulation, Bleed, Stroke, Eliquis