Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation
Effectiveness study (incl. comparative)

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(B01AA) Vitamin K antagonists
(B01AE07) dabigatran etexilate
(B01AF01) rivaroxaban

Medical condition to be studied

Atrial fibrillation
Population studied

Short description of the study population

Participants with nonvalvular atrial fibrillation treated with direct oral anticoagulants (DOAC) (Pradaxa®, Xarelto®) and vitamin K (VKA) utilizing French nationwide claims database identified from 2013 to 31 December 2016.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Patients with nonvalvular atrial fibrillation

Estimated number of subjects

150000
Study design details

Main study objective

The main objective is to compare the one-year risk of major bleeding, risk of stroke and systemic embolism (SSE), risk of myocardial infarction (MI) and risk of death for each DOAC (Pradaxa®, Xarelto®) versus VKA in NVAF during drug exposure.

Outcomes

Clinically relevant bleeding (CRB) as a hospitalisation with primary diagnosis of haemorrhagic stroke, or other critical organ or site bleeding, or other bleedings, SSE as a hospitalisation of ischemic/undefined stroke or systemic arterial embolism, Acute coronary syndrome (ACS) as a hospitalisation of MI or unstable angina, All-cause of death, Composite criterion of CRB/SSE/ACS/death. To compare the long-term risk (2-year and 3-year) of outcomes for each DOAC (Pradaxa®, Xarelto®) versus VKA and for Pradaxa® versus Xarelto® according to the initial dose (standard or reduced dose), drugs use (exposure duration, number of dispensations, medication possession ratio, withdrawal and switch), Healthcare resources use and their related costs on the 1-year of follow-up.

Data analysis plan

Statistical analysis will be carried out according to a documented and approved Statistical Analysis Plan (SAP). The SAP describes statistical analysis as foreseen at the time of planning study. Statistical analysis will be performed after database lock using SAS® software. Blind double programming will be used for the main outcome measures.Primary outcomes will be analysed using survival methods: Kaplan Meier estimate and cumulative incidence function estimate for cumulative incidence of clinical outcomes, Cox proportional hazard risk model and Fine and Gray model to compare incidence of each outcome between treatment groups, for hdPS matched patients, and all patients with hdPS adjustment.The analysis of healthcare costs during the drug exposure will be performed as an “intent-to-treat” analysis on the 1-year follow-up period. Costs will be estimated according to treatment group from national health insurance and collective perspectives.
Documents
Study publications
Blin P, Dureau‐Pournin C, Cottin Y, Bénichou J, Mismetti P, Abouelfath A, Lassa…
Blin P, Dureau-Pournin C, Bénichou J, Cottin Y, Mismetti P, Abouelfath A, Lassa…
Blin P, Dureau‐Pournin C, Cottin Y, Bénichou J, Mismetti P, Abouelfath A, Lassa…