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) (Presage-Aco)

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)."

Study Overview

• Status: Unknown
• Conditions: Non Valvular Atrial Fibrillation (nv AF)
• Intervention / Treatment: Drug: Non-exposed group; Drug: Exposed group

Detailed Description

"• 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."

• Study Type: Observational
• Enrollment (Anticipated): 150000

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Beneficiaries aged ≥ 75 years old initiating a treatment by VKA or NOAC with an non vavular atrial fibrillation (nv AF).

Description

Inclusion Criteria:

• Beneficiaries initiating a treatment by VKA or NOAC during the inclusion period (July 1, 2011 to December 31, 2014).
• Aged ≥ 75 years old et the time of OAC initiation.
• Presenting with an non valvular atrial fibrillation (nv AF).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-exposed group; Non-exposed group / Patients receiving VKA	Drug: Non-exposed group; Non-exposed group / Patients receiving VKA; Other Names: Patients receiving VKA
Exposed group; Exposed group / Patients receiving DOAC	Drug: Exposed group; Exposed group / Patients receiving DOAC; Other Names: Patients receiving DOAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Elderly; Safety; Oral anticoagulants; Cardiology; Risk and Benefit analysis; Health insurance databases
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 16DBT-Presage-Aco

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided