Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
"The aim of the study is to compare, in real life, the risk benefit (including both major bleeding and thrombotic events (TE) and death from any cause) associated with direct oral anticoagulants (DOAC) and with anti vitamin K (VKA) in older adults (≥ 75 years) suffering from nvAF.
The study will be conducted in the French Health insurance database (SNIIRAM). Data of octo+ patients newly treated with an oral anticoagulant (VKA or DOAC) for non valvular atrial fibrillation (nv AF) will be collected from the first exposure of the patient to the drug of interest during the inclusion period to the end of the follow-up period (at least one year of follow-up for each patient)."
"• Context: Oral anticoagulation is recommended for prevention of stroke and thrombo-embolic events in people aged 80 years and over (octo+) suffering from non valvular atrial fibrillation (nv AF) and without contraindication to anticoagulant therapy. Two drug classes are available to achieve this oral anticoagulation: the vitamin K antagonists (VKA, warfarin, fluinione and acenocoumarol) or the Direct Oral Anticoagulants (DOAC, dabigatran, rivaroxaban and apixaban). The data of evidence-based and post-marketing literature on the benefit/risk ratio of DOAC comparatively to VKA are limited, conflicting, potentially biased and finally inconclusive in this population. Nevertheless, this population is the most at risk for nv AF and the population with the highest risk of both AF-related thrombotic events and anticoagulant-related major bleedings.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-exposed group | Non-exposed group / Patients receiving VKA |
| |
| Exposed group | Exposed group / Patients receiving DOAC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-exposed group | Drug | Non-exposed group / Patients receiving VKA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of major thromboembolic events, major bleeding events or death from any cause | Major thromboembolic events include: Ischemic stroke, systemic or pulmonary embolism. Major bleeding is defined as a bleeding resulting in death or requiring hospital admission | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Potential risk factors for major bleeding and TE events in patients exposed to oral anticoagulant | 1 year | |
| Patterns of use of OAC | Patterns of use will be described by : characteristics of the treated population (age, comorbidities leading to hospitalization), drug dose and regimen, time on treatment, concomitant drugs |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Beneficiaries aged ≥ 75 years old initiating a treatment by VKA or NOAC with an non vavular atrial fibrillation (nv AF).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Bonnet-Zamponi, MD | Contact | dominique.bonnet@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Dominique Bonnet-Zamponi, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Exposed group | Drug | Exposed group / Patients receiving DOAC |
|
|
| 1 year |