LARGEST REGISTRY TO DATE TO PROVIDE THE FIRST-EVER PICTURE OF THE REAL GLOBAL BURDEN OF ATRIAL FIBRILLATION (AF)
— Six-year GARFIELD Registry to prospectively follow 50,000 AF patients worldwide —
BARCELONA, 30 August 2009 – The Thrombosis Research Institute (TRI) – a charitable foundation and affiliated institute of Queen Mary University of London – today announced the launch of GARFIELD (Global Anticoagulant Registry in the Field), an innovative research initiative to understand the burden of atrial fibrillation (AF) on a global scale. Atrial fibrillation is a common condition in which the two small upper chambers of the heart (the atria) quiver rather than beat rhythmically and can lead to life-threatening complications, including stroke.
The Garfield Registry will prospectively follow 50,000 patients newly-diagnosed with AF who are also candidates for anticoagulant therapy to prevent blood clots leading to stroke over a six-year period. GARFIELD is launching in 32 countries in the Americas, Eastern and Western Europe, Asia, Africa and Australia, but will ultimately follow patients from 1,000 centers in 50 countries.
“The burden of atrial fibrillation is grossly underestimated, but with an aging world population, the frequency and impact of this disease will continue to increase. We need to better understand AF if we are to begin tackling its consequences in a meaningful way,” said Prof. Ajay Kakkar, Director, Thrombosis Research Institute and Professor of Surgical Sciences at Queen Mary University of London. “GARFIELD is the first real attempt to quantify the global burden of AF, as well as to provide insights into how advances in both anticoagulation and AF management can best be used to reduce the impact of this disease on patients and on health care systems worldwide.”
GARFIELD is the first prospective registry in which clinical sites are randomly selected to participate, avoiding selection of only sites expert in AF management in order to provide a real-world view of how AF is being managed in all care settings (i.e., hospitals, emergency departments, anticoagulant clinics and general practice settings). At each site, consecutive newly-diagnosed patients will be entered into the registry to avoid any potential bias. All entered patients will be newly diagnosed with AF and candidates for long-term anticoagulant therapy with vitamin K antagonists; they will be included whether or not they receive appropriate therapy so the true burden of current treatment failure can be properly understood.
Data are being collected over a six-year period, and will include the following measures: thromboembolic stroke; transient ischemic attacks (TIA, or “mini-strokes”); bloods clots affecting other areas of the body; bleeding events; therapy persistence (rate of and reason for discontinuation or duration of therapy); mortality; and major adverse cardiac events.
Among patients treated with anticoagulant therapy, additional outcomes data also will include the frequency and timing of monitoring required to maintain a safe and therapeutically-effective dose of anticoagulant and interventions required to manage complications due to anticoagulation therapy.
GARFIELD also includes health economic data to determine the true costs of AF globally and in each country participating, as well as a program to assess patient-reported outcomes with regard to the experience of their treatment. The Registry is made possible through a research grant from Bayer Schering Pharma.
The Burden of AF
As many as one percent of the population has AF, including 4.5 million people in the European Union and 2.2 million people in the United States who have persistent AF.1 The condition occurs when parts of the atria emit uncoordinated electrical signals that cause the chambers to pump too quickly and irregularly, thereby not allowing blood to be pumped out of the atria completely. As a result, blood may pool and lead to thrombosis, which is the number one killer in both the developed and developing world.2
If a blood clot leaves the left atrium, then it could potentially lodge in an artery in other parts of the body, particularly in the brain. A blood clot in an artery in the brain leads to a stroke.2 In fact, 92 percent of fatal strokes are caused by thromboses.3 People with AF have a five times higher risk of suffering a stroke than the general population, and are also at high risk for heart failure, chronic fatigue and other heart rhythm problems.1
“Anticoagulant therapy may be necessary for preventing thromboembolic stroke, yet few at-risk patients probably receive appropriate and potentially life-saving prophylactic therapy. The majority of AF patients are elderly, and the currently-available agents, the vitamin-K antagonists, can provide unpredictable anticoagulation in this population,” Prof. Kakkar said. “Through GARFIELD, we will better understand why certain patients are not being given these agents for stroke prevention, and whether some populations who are treated fair better than others.”
About the Thrombosis Research Institute (TRI)
TRI is a multi-disciplinary research and dedicated to the study of thrombosis and related disorders. Comprised of two independent charitable foundations based in London, UK and Bangalore, India, TRI’s mission is to provide excellence in thrombosis research, education and patient care, and to develop new strategies to prevent and treat thrombosis, thereby improving quality of care and advancing clinical outcomes and reducing healthcare costs.
TRI is an affiliated Institute of Queen Mary University of London.
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