Non Valvular Atrial Fibrillation (nv AF) Clinical Trial
Official title:
Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in Patients Aged 75 Years and Over Suffering From Non Valvular Atrial Fibrillation (nv AF) : An Observational Study Conducted on the French Health Insurance Database (SNIIRAM)
"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.
- Objectives: The aim of the study is to assess and compare the real benefits and harms
of the two therapeutic strategies available in routine practice, for the
anticoagulation in patients 75 years old or more suffering from nvAF. The main
objective is to estimate and compare DOAC and VKA in terms of major bleeding,
thrombotic events (TE) and death of all cause in 75 years old or more suffering from nv
AF. The secondary objectives are to identify factors associated with the occurrence of
these events, taking into account the type of anticoagulant, to identify factors
associated with the occurrence of these events, taking into account switches from VKA
to DOAC or DOAC to VKA, and to describe the utilization patterns of oral
anticoagulants.
- Design and statistical analyses: An observational study will be conducted in the French
administrative database (SNIIRAM). The SNIIRAM database contains anonymous and
prospectively recorded data about all beneficiaries' medical reimbursements including
age, gender, long-term chronic disease (LTD), date of death, all out-hospital
health-spending reimbursements and all patients' hospitalizations. We will include all
octo+ patients they care for, newly treated ("new users") with an oral anticoagulant
(VKA or DOAC) for nv AF, at the date of first prescription of oral anticoagulant. From
the date, patients data will be collected during at least 2 years. To assess the
principal endpoint, we will estimate the time between the date of inclusion and the
date of occurrence of a major thromboembolic event, major bleeding event, or death from
any cause, whichever comes first. Exposure will be considered as time-dependant. The
total number of patients expected is 150 000."
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Observational Model: Cohort, Time Perspective: Retrospective