Thromboembolic stroke represents a major challenge and its prevention will be a defining component of population healthcare in the 21st century. The Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) has the potential to enhance the breadth and depth of understanding of stroke prevention in atrial fibrillation and ultimately help to develop strategies for improving patient outcomes worldwide.
GARFIELD-AF is an academic research initiative owned by the Thrombosis Research Institute (TRI) in order to improve our understanding of the global burden and treatment of atrial fibrillation, in particular the prevention of stroke with anticoagulant therapy.
GARFIELD-AF will describe the treatment patterns and outcomes of patients with newly diagnosed non-valvular AF and one or more additional investigator-determined risk factor for stroke. The registry will provide unique and important insights into real-life treatment-initiation strategies, long-term management and related clinical outcomes of AF patients from a global perspective. The inclusion of consecutive, treatment-naive patients with newly diagnosed non-valvular AF – irrespective of age, presence of comorbid conditions, and treatment or lack of treatment with anticoagulant therapy – will provide a representative view of AF management in unselected populations and across the spectrum of national healthcare systems.
To evaluate the management and outcomes of patients with newly diagnosed non-valvular AF and ≥1 additional risk factor for stroke, by:
- Describing real-life treatment patterns
- Assessing rates of stroke and systemic embolism
- Assessing outcomes, with specific reference to the incidence of bleeding complications; therapy persistence (including discontinuation, interruption, and changes of regimen); and fluctuations in the international normalized ratio (INR) for patients on vitamin K antagonists
The GARFIELD-AF study design is a novel approach to observational research, providing an unprecedented insight into everyday clinical practice. Its unique features are:
i. Independent academic research initiative
Providing real-world evaluation of existing guidelines and identification of comprehensive value-based healthcare strategies
ii. 55,000 patients to be recruited at more than 1000 sites in 34 countries
Describing treatments and outcomes nationally and globally in the largest ever AF registry
iii. 5 independent, sequential prospective cohorts
Describing the evolution of practice over time
iv. Consecutive enrolment of newly-diagnosed patients regardless of therapy
Describing an unbiased patient population
v. Sites selected randomly within a carefully assigned distribution of national care settings
Describing a representative and diverse group of patients and distinctive populations
vi. Follow-up for 2 years after diagnosis
Describing treatment and outcomes in the long term
The GARFIELD-AF registry is an observational, multicentre, international prospective study of men and women newly diagnosed with AF and at least one additional investigator-determined risk factor for stroke. The registry will enrol 55,000 patients at more than 1000 centres in 34 countries, providing a representative description of the burden of atrial fibrillation in everyday clinical practice.
Enrolment will take place in five independent, sequential, prospective cohorts, facilitating the description of an evolving field over time. A retrospective validation group of 5000 patients with established AF and at least one additional risk factor for stroke was conducted as part of the first cohort.
The first cohort was conducted at 543 active sites in 19 countries (Australia, Austria, Brazil, Canada, China, Denmark, Korea, Finland, France, Germany, Italy, Japan, Mexico, Norway, Poland, Spain, the Netherlands and UK). The second cohort (initiated in October 2011) extended to a further 11 countries (Argentina, Belgium, Chile, Czech Republic, Hungary, India, Russia, Singapore, South Africa, Thailand, Ukraine) and 952 active sites. In the third cohort, five countries (UAE, USA, Turkey, Switzerland and Egypt) and 949 active sites were added. Additional countries will continue to be added in future cohorts, with the registry eventually encompassing 34 countries. Each site will recruit, on a consecutive basis, up to 30 patients.
The registry started in December 2009, with a planned 7 years of patient recruitment and a minimum of 2 years and up to 8 years of follow-up for each patient.
Baseline data and main outcome measures
At baseline, data will be collected on patient demographics, medical history, nature of AF, date and method of diagnosis, symptoms and treatment decisions.
Local investigators will complete electronic case report forms at 4-monthly intervals for each patient, for a minimum of 2 years and up to 8 years. Outcome data will include clinical and bleeding events, therapy persistence, healthcare resource use, and changes in treatment regimen.
GARFIELD-AF in perspective
Completion of patient enrolment into Cohort 1 – in October 2011 – coincided with regulatory approval in several countries of novel oral anticoagulant agents for stroke prevention in non-valvular AF. The GARFIELD-AF registry will be in a strong position to document and describe how far the introduction of novel anticoagulants influences patient management and impacts outcomes in this field. The unique study design, with comprehensive data collection in sequential cohorts, will provide representative, real-world insights into treatments for AF and associated clinical outcomes, for the benefit of patients, clinicians and healthcare providers.