One-Year Outcomes Data on Stroke Prevention in Patients With Newly Diagnosed Atrial Fibrillation (AF) to Be Presented at ISTH 2015

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Thrombosis Research Institute (TRI)

18 Jun, 2015, 06:30 BST

LONDON, June 18, 2015 /PRNewswire/ --

-- Two oral presentations of GARFIELD-AF Registry data will provide real-life insights into the impact of patient risk profiles and poor anticoagulation control on stroke prevention in AF -- 

New analyses from the Global Anticoagulant Registry in the Field - Atrial Fibrillation (GARFIELD-AF) will be presented at the XXV Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Toronto, Canada, June 20-25, 2015. The two GARFIELD presentations will include real-life data on stroke prevention from nearly 17,200 patients, providing physicians with further information on how patient risk profiles and quality of vitamin K antagonist control are associated with increased mortality and stroke in patients with newly diagnosed AF.

The GARFIELD-AF oral presentations at ISTH 2015 will cover:  

Risk profiles and 1-year outcomes of patients with newly diagnosed atrial fibrillation: Results from GARFIELD-AF (Abstract OR119) 

  • Oral Session: Oral Communications 2: Stroke
  • Monday 22 June, 2015, 14:45-15:00, Room 709

The incidence of stroke/systemic embolism, death and major bleeding one year after a new diagnosis of non-valvular AF were analysed by patients' baseline characteristics and antithrombotic therapy provided at diagnosis.

Quality of vitamin K antagonist control and 1-year outcomes: A global perspective from the GARFIELD-AF Registry (Abstract OR096) 

  • Oral Session: Oral Communications 2: Vitamin K antagonists
  • Monday 22 June, 2015, 14:00-14:15, Room 715

The study analysed time in therapeutic range (TTR) and optimal international normalised ratio (i.e. INR range 2.0-3.0) in patients with newly diagnosed non-valvular AF in relation to demographics, care settings and 1-year outcomes.

The GARFIELD-AF Registry will enhance the breadth and depth of the understanding of stroke prevention in AF, and ultimately will help to develop strategies for improving patient outcomes worldwide.

Baseline data from GARFIELD-AF (now available for 31,666 patients) indicates that, currently, the management of many newly diagnosed patients is not consistent with evidence-based guidelines, with patients inappropriately receiving anticoagulants or being under-treated with anticoagulants, despite the increasing availability of non-vitamin K antagonist oral anticoagulants (NOACs).  The impact of sub-optimal management strategies on outcomes demonstrated in the GARFIELD-AF presentations at ISTH suggests a cause for ongoing concern.

GARFIELD-AF is an independent academic research initiative, led by an international steering committee under the auspices of the Thrombosis Research Institute (TRI), London, UK. To date, GARFIELD-AF has recruited over 40,000 patients with newly diagnosed AF in 35 countries, making it one of the largest observational studies in this therapeutic area. With recruitment for Cohort 5 about to start, the Registry will eventually include up to 57,000 patients.

About the GARFIELD-AF Registry  

GARFIELD-AF is an observational, multicentre, international prospective study of patients with newly diagnosed AF.  It will prospectively follow 57,000 patients from at least 1,000 centres in 35 countries in the Americas, Eastern and Western Europe, Asia, Africa and Australia.

Contemporary understanding of AF is based on data gathered in controlled clinical trials. Whilst essential for evaluating the efficacy and safety of new treatments, these trials are not representative of everyday clinical practice and, hence, uncertainty persists about the real-life burden and management of this disease. GARFIELD-AF seeks to provide insights into the impact of anticoagulant therapy on thromboembolic and bleeding complications seen in this patient population. It will provide a better understanding of the potential opportunities for improving care and clinical outcomes amongst a representative and diverse group of patients and across distinctive populations. This should help physicians and healthcare systems to appropriately adopt innovation to ensure the best outcomes for patients and populations.

The registry started in December 2009. Four key design features of the GARFIELD-AF protocol ensure a comprehensive and representative description of AF, these are:

  • Five sequential cohorts of prospective, newly-diagnosed patients, facilitating comparisons of discrete time periods and describing the evolution of treatments and outcomes.
  • Investigator sites that are selected randomly within carefully assigned national AF care setting distributions, ensuring that the enrolled patient population is representative.
  • Enrolment of consecutive eligible patients regardless of therapy to eliminate potential selection bias.
  • Follow-up data captured for a minimum of 2 and up to 8 years after diagnosis, to create a comprehensive database of treatment decisions and outcomes in everyday clinical practice.

Included patients must have been diagnosed with non-valvular AF within the previous 6 weeks and have at least one additional risk factor for stroke; as such they are potential candidates for anticoagulant therapy to prevent blood clots leading to stroke. It is left to the investigator to identify a patient's stroke risk factor(s), which need not be restricted to those included in established risk scores. Patients are included whether or not they receive anticoagulant therapy, so current and future treatment strategies and failures can be properly understood in relation to patients' individual risk profiles.

The GARFIELD-AF Registry is funded by an unrestricted research grant from Bayer Pharma AG.

The burden of AF  

Up to 2% of the global population has AF.[1] Around 6 million people in Europe[2], 3-5 million people in the United States[3],[4] and up to 8 million people in China have AF.[5],[6] It is estimated that its prevalence will at least double by 2050 as the global population ages. AF confers a five-fold increase in the risk of stroke, and one in five of all strokes is attributed to this arrhythmia. Ischaemic strokes associated with AF are often fatal, and those patients who survive are left more frequently and more severely disabled and more likely to suffer a recurrence than patients with other causes of stroke. In consequence, the risk of death from AF-related stroke is doubled and the cost of care is increased by 50%.[7]

AF occurs when parts of the atria emit uncoordinated electrical signals. This causes the chambers to pump too quickly and irregularly, not allowing blood to be pumped out completely.[8] As a result, blood may pool, clot and lead to thrombosis, which is the number one cardiovascular killer in the world.[9] If a blood clot leaves the left atrium, it could potentially lodge in an artery in other parts of the body, including the brain. A blood clot in an artery in the brain leads to a stroke. Ninety-two per cent of fatal strokes are caused by thrombosis.[9] People with AF also are at high risk for heart failure, chronic fatigue and other heart rhythm problems.[10] Stroke is a major cause of death and long-term disability worldwide - each year 6.7 million people die[11] and 5 million are left permanently disabled.[12]

About the TRI  

The TRI is a charitable foundation and multi-disciplinary research institute dedicated to the study of thrombosis and related disorders. TRI's mission is to provide excellence in thrombosis research and education, to develop new strategies to prevent and treat thrombosis and thereby improve quality of care, advance clinical outcomes and reduce healthcare costs. The TRI is a member of University College London Partners Academic Health Science System.

For more information, visit http://www.tri-london.ac.uk/garfield.

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  1. Davis RC, Hobbs FD, Kenkre JE, et al. Prevalence of atrial fibrillation in the general population and in high-risk groups: the ECHOES study. Europace 2012; 14(11):1553-9. 6/16/15. Available at: http://europace.oxfordjournals.org/content/14/11/1553.long
  2. The Lancet Neurology. Stroke prevention: getting to the heart of the matter. Lancet Neurol 2010; 9(2):129. 6/16/15. Available at: http://www.atrialfibrillation.org.uk/files/file/Articles_Medical/Lancet%20Neurology-%20getting%20to%20the%20heart%20of%20the%20matter.pdf
  3. Naccarelli GV, Varker H, Lin J, et al. Increasing prevalence of atrial fibrillation and flutter in the United States. Am J Cardiol 2009; 104(11):1534-9.
  4. Colilla S, Crow A, Petkun W, et al. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol 2013; 112(8):1142-7. 6/16/15. Available at: http://www.ajconline.org/article/S0002-9149(13)01288-5/fulltext
  5. Zhou Z, Hu D. An epidemiological study on the prevalence of atrial fibrillation in the Chinese population of mainland China. J Epidermiol 2008; 18(5):209-16. 6/16/15. Available at: https://www.jstage.jst.go.jp/article/jea/18/5/18_JE2008021/_pdf
  6. Hu D, Sun Y. Epidemiology, risk factors for stroke, and management of atrial fibrillation in China. JACC 2008; 52(10):865-8. 6/16/15. Available at: http://www.sciencedirect.com/science/article/pii/S0735109708021141
  7. European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery, Camm AJ, Kirchhof P, Lip GY, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). 8/22/14. Eur Heart J 2010; 31(19):2369-429. 6/16/15. Available at: http://eurheartj.oxfordjournals.org/content/early/2010/09/25/eurheartj.ehq278.full
  8. National Heart, Lung, and Blood Institute. What is Atrial Fibrillation? 6/16/15. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html
  9. International Society on Thrombosis and Haemostasis. About World Thrombosis Day. Available at: http://www.worldthrombosisday.org/about/
  10. American Heart Association. Why Atrial Fibrillation (AF or AFib) Matters. 8/22/14. Available at: http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AboutArrhythmia/Why-Atrial-Fibrillation-AF-or-AFib-Matters_UCM_423776_Article.jsp
  11. World Health Organization. The top 10 causes of death. Fact sheet No 310. Updated May 2014. 6/16/15. Available at: http://www.who.int/mediacentre/factsheets/fs310/en/
  12. World Heart Federation. The global burden of stroke. 6/16/15. Available at: http://www.world-heart-federation.org/cardiovascular-health/stroke/

SOURCE Thrombosis Research Institute (TRI)