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TRI Release: Landmark GARFIELD-AF Data To Be Presented At ESC 2017 Congress Will Feature 1-Year Outcomes On 52,000 Prospective Patients And The First Insights From The Registry On Health Economics In Atrial Fibrillation (AF)



8/22/2017 7:05:26 AM

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LONDON, August 22, 2017 /PRNewswire/ --

  • One-year stroke/systemic embolism and major bleeding rates for all five cohorts will be discussed, as well as the impact of comorbidities   
  • Global data are expected to show significant geographical variation in the amount and type of health services used by patients  
  • The results will confirm that premature mortality adds substantially to the already considerable direct cost of AF  
  • The latest results from the Global Anticoagulant Registry in the Field - Atrial Fibrillation (GARFIELD-AF) will be presented at ESC Congress 2017, organised by the European Society of Cardiology, to be held in Barcelona, Spain, from August 26th to 30th. Data will be presented during congress sessions as well as at a dedicated Satellite Symposium.

    The registry has started to yield health economic data, which will be presented for the first time at ESC Congress 2017, confirming the high financial, economic and human burden AF imposes on societies, and the vast amount of healthcare resource utilised. Based on data from around 40,000 patients with atrial fibrillation from 35 countries worldwide, the poster presentation will describe the geographical variation in the amount and type of health services used by patients, which is potentially associated with the actual availability of services and different models of organisation of care.

    "With GARFIELD-AF data showing how the significant burden of AF in terms of morbidity and mortality from stroke and heart failure translates to significant effects on healthcare costs and resource use, we need clinical strategies that can reduce AF-related hospitalisations, improve clinical outcomes and reduce the economic burden," said Rt Hon Professor the Lord Ajay K. Kakkar, Professor of Surgery at University College London and Director of the Thrombosis Research Institute (TRI), UK.

    GARFIELD-AF is the largest ongoing prospective registry of patients with AF. It is a pioneering, independent outcomes research initiative led by an international steering committee under the auspices of the TRI. In total, 57,262 patients have been enrolled, of which 52,000 are prospective. This is the first time 1-year outcomes data from all of the prospective patients will be presented.

    Key results will be unveiled during the TRI Satellite Symposium and at an ESC Congress Best Poster session:

    Atrial fibrillation - a bystander or cause of morbidity and mortality: insights from the GARFIELD-AF registry  

    • Satellite Symposium
    • Saturday 26th August 2017 at 15:30 - 17:00 (all times CEST),  Beirut - Village 3

    Members of the GARFIELD-AF Steering Committee will present a range of results, including 1-year outcomes for 52,000 prospective patients and perspectives on the comprehensive treatment of AF with comorbidities such as heart failure, acute coronary syndrome, chronic kidney disease and obesity.

    TRI will also be broadcasting the Satellite Symposium live via Periscope. Follow the GARFIELD registry @GARFIELD_reg on Twitter to tune in and be part of the conversation.

    One-year clinical outcomes and management of patients with ischaemic vs non-ischaemic cardiomyopathy and newly diagnosed atrial fibrillation: results from GARFIELD-AF [P3237]  

    • Best Posters
    • Monday 28th August at 08:30, Best poster screen - Poster Area

    Professor Ramon Corbalan will report that the one-third of patients with congestive heart failure (CHF) who also had ischaemic cardiomyopathy had worse outcomes compared to those with non-ischaemic cardiomyopathy. In addition, they were less frequently anticoagulated, more frequently received antiplatelet therapy, and were prescribed fewer CHF medications than patients with non-ischaemic cardiomyopathy.

    This poster will be on display at 08:30 - 12:30 on a Best Poster plasma screen, and during the viewing time (10:05 - 10:55) a discussant will lead a discussion on the poster.

    An additional six GARFIELD-AF posters will also be presented on Monday 28th August. They will be on display either in the morning session (08:30 - 12:30) or in the afternoon session (14:00 - 18:00). Presenters will be by their posters at 10:00 - 11:00 and 15:30 -16:30, respectively.

    Poster Session 4 - Poster Area (08:30 - 12:30)  

    Impact of body mass index in newly diagnosed atrial fibrillation in the GARFIELD-AF registry [P3569]  

    Professor Samuel Goldhaber (Boston, USA) will describe how patients with morbid obesity (and associated metabolic syndrome) were almost 10 years younger (median) than patients of normal weight when diagnosed with AF. As body mass index increased, mortality paradoxically decreased in GARFIELD-AF. Furthermore, underweight patients were at higher risk of death (versus normal weight patients) in the 2 years after AF diagnosis.

    Which definition of hypertension best defines thromboembolic risk in patients with atrial fibrillation? Data from the GARFIELD-AF registry [P3609]  

    Professor John Camm (London, UK) will explain that the majority of patients with newly diagnosed AF had a history of hypertension. This history conferred a higher risk of stroke than observed in those without a hypertension history. Trends in unadjusted event rates indicate that increasing severity of uncontrolled hypertension may contribute to the risks of stroke and major bleeding, but not all-cause mortality in this population.

    Poster Session 5 - Poster Area (14:00 - 18:00)  

    Global healthcare resource use in 39,670 patients with AF: perspectives from GARFIELD-AF [P4594]  

    Dr Paolo Cozzolino (Monza, Italy) will review the vast amount of healthcare resource utilised in nearly 40,000 patients with AF from 35 countries worldwide as well as the significant geographical variation in the amount and type of health services used by patients.

    Differences in 2-year outcomes according to type of atrial fibrillation: results from the GARFIELD-AF registry [P4601]  

    Professor Dan Atar (Oslo, Norway) will report that persistent and permanent AF were associated with higher mortality risk versus paroxysmal AF but had similar adjusted risks of stroke/systemic embolism and major bleeding during 2 years of follow-up.

    Similar clinical outcomes of asymptomatic and symptomatic patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF [P4602]  

    Dr Harry Gibbs (Melbourne, Australia) will discuss the one-fifth of patients newly diagnosed with AF who had no symptoms. Prescription of antithrombotic therapies was similar in asymptomatic and symptomatic patients. Adjusted 1-year mortality, stroke/systemic embolism and major bleeding were similar in each group, indicating that asymptomatic newly diagnosed AF is not benign. This supports systematic approaches to detect and treat asymptomatic AF.

    The burden of atrial fibrillation in the more populated European countries: perspectives from the GARFIELD-AF registry [P4603]  

    Professor Lorenzo Mantovani (Monza, Italy) will explain that AF imposes a high financial, economic and human burden to societies - and that, based on population dynamics, the burden is likely to grow in the future. Premature mortality substantially adds to the already considerable direct cost of the disease.

    National Data Showcases  

    Data showcases for Chile, Germany, Japan, Spain and the UK are also scheduled throughout ESC Congress 2017 at the TRI exhibition stand (Stand G500 - Village 3):

    Sunday 27th August 11:00 - 11:30 UK data showcase Professor David A Fitzmaurice 13:00 - 13:30 Japan data showcase Professor Yukihiro Koretsune Monday 28th August 12:00 - 12:30 Chile data showcase Professor Ramon Corbalan 14:00 - 14:30 Spain data showcase Dr Xavier Viñolas Tuesday 29th August 12:00 - 12:30 Germany data showcase Professor Harald Darius

    About the GARFIELD-AF registry   

    GARFIELD-AF is the largest ongoing prospective registry of patients with AF. 2016 marked the end of the enrolment phase for GARFIELD-AF, with 57,262 patients enrolled of which 52,000 are prospective. The real-world insights that continue to be gathered from the GARFIELD-AF registry are being converted into real-world evidence that helps inform and identify areas where the medical community can continue to improve patient outcomes.

    GARFIELD-AF is a pioneering, independent academic research initiative led by an international steering committee under the auspices of the TRI, London, UK.

    It is an international, non-interventional study of stroke prevention in patients with newly diagnosed AF. Patients were enrolled from over 1,000 centres in 35 countries worldwide, including from the Americas, Europe, Africa and Asia-Pacific.

    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 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 that the merit of current and future treatment strategies can be properly understood in relation to patients' individual risk profiles.

    The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer AG, Berlin, Germany.

    For more information, visit our website: http://www.garfieldregistry.org 

    The burden of AF   

    Up to 2% of the global population has AF,[1] including around 8.8 million people in Europe[2] and 5-6.1 million in the United States.[3] It is estimated that its prevalence will at least double by 2050 as the global population ages.[3] AF is associated with a five-fold increase in stroke risk, and one out of five strokes is attributed to this arrhythmia.[1] Ischaemic strokes related to AF are often fatal, and those patients who survive are left more frequently and more severely disabled and have a greater risk of recurrence than patients with other causes of stroke.[1] Hence, the risk of mortality from AF-associated stroke is doubled and the cost of care is 50% higher.[1]

    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.[4] As a result, blood may pool, clot and lead to thrombosis, which is the number one cardiovascular killer in the world.[5] 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; 92% of fatal strokes are caused by thrombosis.[5] Stroke is a major cause of death and long-term disability worldwide - each year, 6.5 million people die[6] and 5 million are left permanently disabled.[7] People with AF also are at high risk for heart failure, chronic fatigue and other heart rhythm problems.[8]

    About the TRI    

    The TRI is dedicated to bringing new solutions to patients for the detection, prevention and treatment of blood clots. The TRI's goal is to advance the science of real-world enquiry so that the value of real-world data is realised and becomes a critical link in the chain of evidence. Our pioneering research programme, across medical disciplines and across the world, continues to provide breakthrough solutions in thrombosis.

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

    1. Camm A J, Kirchhof P, 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). Eur Heart J 2010; 31(19):2369-429.
    2. Krijthe B P, Kunst A, et al. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J 2013; 34:2746-51.
    3. 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.
    4. National Heart, Lung, and Blood Institute. What is Atrial Fibrillation? Available at: http://www.nhlbi.nih.gov/health/health-topics/topics/af/ . [Last accessed: 1 August 2017].
    5. World Thrombosis Day. Know Thrombosis. Available at: http://www.worldthrombosisday.org/issue/thrombosis/ . [Last accessed: 1 August 2017].
    6. World Stroke Organization. World Stroke Campaign. Available at: http://www.worldstrokecampaign.org/ . [Last accessed: 1 August 2017].
    7. Stroke Centre. Stroke Statistics. Available at: http://www.strokecenter.org/patients/about-stroke/stroke-statistics/ . [Last accessed: 1 August 2017].
    8. American Heart Association. Why Atrial Fibrillation (AF or AFib) Matters. Available at: http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AboutArrhythmia/Why-Atrial-Fibrillation-AF-or-AFib-Matters_UCM_423776_Article.jsp . [Last accessed: 1 August 2017].

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