GARFIELD-AF is a pioneering, independent outcomes research initiative led by an international steering committee under the auspices of the Thrombosis Research Institute (TRI), London, United Kingdom
Global Information
Recruitment – complete
Total Patients Enrolled – 57,262
- 5,080 Retrospective
- Cohort 1 – 5,505
- Cohort 2 – 11,681
- Cohort 3 – 11,485
- Cohort 4 – 11,310
- Cohort 5 – 12,201
Objectives
Thromboembolic stroke represents a major challenge and its prevention will be a defining component of population healthcare in the 21st century.
This worldwide observational programme aims to enhance the breadth and depth of understanding of stroke prevention in atrial fibrillation (AF), ultimately informing strategies to improve patient outcomes, safety and utilisation of healthcare resources.
GARFIELD-AF offers a unique opportunity to obtain a comprehensive and contemporary description of the spectrum of patients with AF and their management worldwide as they evolve over time.
GARFIELD-AF is important in bridging the gap between research and clinical practice, serving to increase awareness of the importance of thrombosis and its treatment.
Travel Through Our Timeline
Scroll over the window below to view our timeline
- First Patient
- First data presented Baseline data describing global treatment patterns
- Cohort 1 Complete 10,618 patient describing the end of the VKA only era
- Methods Paper published
- Preliminary Follow-up Data
First description of outcomes according to treatment - Cohort 1 Baseline Paper published
- Cohort 2 Complete
11,787 prospective patients recruited in 35 countries Cohort 3 Starts - Cohort 3 Complete
33,751 patients recruited in 35 countries - Cohort 4 Starts
- Gender Baseline Paper published
- Cohort 4 Complete and Start of Cohort 5 45,050 patients recruited in 35 countries
- Cohort 5 57,262 patients enrollled; recruitment completed
Study Design
GARFIELD-AF is recruiting patients with newly diagnosed nonvalvular AF and at least one risk factor for stroke.
Patients have been recruited over five sequential cohorts.
Follow-up is over a minimum of 2 years and up to 8 years after diagnosis, to create a comprehensive database of treatment decisions and outcomes in everyday clinical practice.
Challenges associated with observational studies and design features of GARFIELD-AF
| Challenges | Design features of GARFIELD-AF registry |
|---|---|
| Capturing the whole burden of disease | Prospective recruitment of patients with long-term follow-up
|
| Ensuring high quality data | Comprehensive programme of audit and quality control
|
| Describing everyday clinical practice | Non-interventional study design
|
| Enrolling a representative sample of patients | Unrestricted inclusion criteria
|
Patient Eligibility
Patient eligibility
- Age 18 years and over
- New diagnosis of non-valvular atrial fibrillation (diagnosed within the last 6 weeks) with at least one investigator-determined risk factor for stroke
End Points
Over a period of 8 years (between December 2009 and August 2018), GARFIELD-AF will:
- Describe changes in treatment practice
- Quantify rates of stroke and systemic embolism, major bleeding and all-cause mortality
- Assess therapy persistence (including discontinuation, interruption, and changes of regimen) and fluctuations in the international normalised ratio for patients on vitamin K antagonists
Quality Assurance
GARFIELD-AF is governed by the highest academic and ethical standards in the generation, dissemination, and communication of its research findings
Audit requirements
- 20% of all electronic case report forms are monitored against source documentation
- Electronic audit trail for all data modifications
- Critical variables are subjected to additional audit
- Compliant with Declaration of Helsinki