Internationally renowned for pioneering, multi-disciplinary research, the Thrombosis Research Institutes comprise two independent charitable foundations based in London, United Kingdom and Bangalore, India.

 

Garfield Registry

 

The GARFIELD REGISTRY:

In August 2009, the Thrombosis Research Institute launched GARFIELD – the Global Anticoagulant Registry in the FIELD. This academic research initiative was designed to enhance understanding of the burden of atrial fibrillation (AF) on a global scale. The data collected in the GARFIELD registry will allow for important insights into how advances in anticoagulation and AF management can best be used to reduce the clinical impact of AF for patients and the economic burden for healthcare systems.

BACKGROUND AND RATIONALE

ATRIAL FIBRILLATION AND STROKE

The prevalence of AF increases with age, affecting fewer than 1% of individuals under 60 years of age, approximately 4% of individuals aged over 60 years, and up to 10% of those over 80 years (1, 2). This translates into 4.5 million individuals in the European Union and 2.2 million in the United States.

AF is the most common clinically significant arrhythmia in the adult population. It is a strong, independent risk factor for cerebrovascular accidents (CVA) and is responsible of about 15% of all ischaemic strokes in patients over the age of 60 years in the United States (1). Patients with non-valvular AF are five times more likely to suffer a stroke while patients with valvular AF see their risk increase about 17 times (3).

Considering the impact of an ageing population throughout the developed world, the frequency of reported CVAs is expected to double over the next decade (2).

HEALTH ECONOMIC IMPACT OF AF-RELATED STROKE

The total cost of stroke in Europe was calculated to be €38 billion in 2006 (4). The economic burden of stroke in the United States was estimated to be approximately $US31 billion in direct costs and over $US20 billion in indirect costs in 2005 (5).

Health economic studies on healthcare costs and quality of life in stroke survivors have shown that AF-related strokes are associated with higher cost and more pronounced impact on quality of life than in stroke patients without AF (6, 7).

UNMET THERAPEUTIC NEEDS IN AF

Oral anticoagulation treatment has been shown to be effective in numerous randomized clinical trials. Patients receive long-term oral anticoagulation with vitamin K antagonists (VKAs) in an attempt to prevent the development of stroke or systemic emboli. The rationale behind this therapy is driven by the recognition that the pathological mechanisms responsible for the initiation of thrombi in the left atrium are responsive to antithrombotic intervention, and trial data indicating that long-term chronic oral anticoagulation can reduce the frequency of thromboembolic events and mortality. There remains, however, reluctance amongst clinicians to provide routine oral anticoagulation to patients with AF, despite the potential clinical benefits (8).

As a result of the challenges associated with VKA therapy, considerable effort is now being directed towards the development of novel orally active anticoagulants that are not associated with many of the disadvantages of the VKAs.

In the setting of clinical trials in AF, regulatory authorities mandate very tight control of anticoagulant therapy, resulting in lower rates of therapeutic failure than usually seen in everyday clinical practice, making accurate assessment of the value of novel antithrombotic agents difficult and an evaluation of the full health-economic benefits of these therapies impossible.

Therefore an observational registry is needed in order to quantify and understand the management of AF in ‘real-life’ clinical practice and to identify the associated clinical and economic impact.

GARFIELD - Clinical Research Details

TITLE

Prospective, multicentre, international registry of male and female patients newly diagnosed with AF.

PURPOSE

To discover the treatment patterns and outcomes of newly diagnosed patients with AF with at least one additional risk factor for stroke in everyday clinical practice.

OBJECTIVE

1. To describe the real-life treatment patterns in newly diagnosed patients with AF with at least one additional risk factor for stroke.
2. To assess the rate of stroke and systemic embolization in these patients.
3. To assess the outcome of these patients, with specific reference to:

    • the incidence of bleeding complications;
    • for patients on VKA therapy, INR fluctuations over time; and
    • therapy persistence.

DESIGN

GARFIELD is a non-interventional, multicentre, prospective registry of male and female patients newly diagnosed with AF with at least one additional risk of stroke.

GARFIELD is unique in that it will prospectively register unselected, consecutive newly diagnosed patients with non-valvular AF irrespective of whether they receive intervention. In this way, it will discover a previously unseen picture of the burden and treatment of AF patients in everyday clinical practice.

GLOBAL SCOPE AND DURATION

A total of 50,000 patients with newly diagnosed non-valvular AF with at least one additional risk factor for stroke will be enrolled in 50 countries and 1000 participating centres across Europe, Asia, Australia, Africa and the Americas.

Eligible patients will be identified in multiple care settings, including hospital centres, anticoagulation clinics, at GP surgeries and emergency departments. To ensure an accurate representation of real-world AF treatment, sites will be selected to represent the national care setting distribution on a geographical basis. Sites will be selected randomly and invited to participate.

Patients will be enrolled as five sequential independent cohorts of 10,000 patients each.

Enrolment into the first cohort was completed in October 2011, and included a validation group of 5000 patients. These patients had been diagnosed with non-valvular AF a minimum of 6 months and no longer than 2 years previously and managed at the registry sites. The progress of these patients will also be recorded prospectively for up to 2 years.

All patients satisfying the inclusion and exclusion criteria will be considered for enrolment. Consecutive patient enrolment will play a key role in ensuring that the patient population in the GARFIELD registry is representative of the global AF population.

The total registry duration is anticipated to be 6 years, allowing 4 years for recruitment and 2 years of follow-up for each patient.

COORDINATING AND CHIEF INVESTIGATOR

Professor the Lord Kakkar
Thrombosis Research Institute
Emmanuel Kaye Building
Manresa Road
London SW3 6LR
United Kingdom

FOR INFORMATION ON GARFIELD

Please contact the Thrombosis Research Institute at garfield@tri-london.ac.uk

GARFIELD Investigators should contact TRIGarfieldsupport@quintiles.com with questions relating to the local registry management including all administrative and technical aspects

References

1. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Registry. Arch Intern Med 1987;147(9):1561-4.
2. Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Registry. Jama 2001;285(18):2370-5.
3. Rockson SG, Albers GW. Comparing the guidelines: anticoagulation therapy to optimize stroke prevention in patients with atrial fibrillation. J Am Coll Cardiol 2004;43(6):929-35.
4. Allender, Scarborough P, Petro V et al. European Cardiovascular Disease Statistics 2008 Edition.
5. Waldo AL, Becker RC, Tapson VF, Colgan KJ. Hospitalized patients with atrial fibrillation and a high risk of stroke are not being provided with adequate anticoagulation. J Am Coll Cardiol 2005;46(9):1729-36.
6. Gage BF, Cardinalli AB, Owens DK. The effect of stroke and stroke prophylaxis with aspirin or warfarin on quality of life. Arch Intern Med 1996; 156: 1829-36.
7. Ghatnekar O, Glader EL. The effect of atrial fibrillation on stroke- related inpatient costs in Sweden: a 3-year analysis of registry incidence data from 2001. Value Health 2009; 11: 862-8.
8. Emmerich J, Hauzey J-YL, Bath PMW, Connoly SJ. Indication for antithrombotic therapy for atrial fibrillation: reconciling the guidelines with clinical practice. European Heart Journal Supplements 2005;7(Supplement C):C28-C33.

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