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One-year outcomes data from the first cohort of the Global Anticoagulant Registry in the FIELD (GARFIELD), an innovative, independent academic research initiative, provide insights into the elevated stroke risk among subpopulations of patients with atrial fibrillation (AF). The findings, from eight abstracts presented this week at the ESC Congress 2013, collectively show that anticoagulant therapy - which is known to significantly lower stroke risk in AF patients - is consistently under-utilised among those at-risk AF patients.
GARFIELD is led by an international steering committee under the auspices of the Thrombosis Research Institute (TRI), London. It is an international, observational, multicentre, prospective study designed to understand the global burden of AF, a common condition in which the two upper chambers of the heart (the atria) quiver rather than beat rhythmically and can lead to life-threatening complications, including stroke. Up to 2% of the population has AF. Despite the availability of highly effective preventive treatments, AF-related stroke remains a major and increasing clinical and societal burden.
"These 1-year data from GARFIELD illustrate that evidence-based stroke prevention guidelines are not always followed in everyday clinical practice," said Professor The Lord Ajay Kakkar, Professor of Surgery at University College London and Director of the TRI, London, UK. "Taken together, these new findings re-emphasize what has been observed in clinical trials regarding stroke risk in AF patients. The research suggests there are opportunities to improve patient outcomes through more consistent application of best practice and adoption of the many innovative therapies to prevent stroke in high-risk AF patients."
The data presented at ESC Congress 2013 are from the first of five GARFIELD cohorts. The first cohort includes a total of 10,614 patients with non-valvular AF and at least one investigator-determined additional risk factor for stroke, recruited from 540 randomly-selected sites in 19 countries. Of these patients, 5,089 were recruited retrospectively as a validation cohort and 5,525 were recruited prospectively and comprise the study populations in these abstracts. ESC Guidelines for the management of atrial fibrillation recommend that all patients at high risk of stroke be prescribed anticoagulation therapy with vitamin K antagonists (VKAs), unless contraindicated. High stroke risk is defined as a score ≥2 on the CHA2DS2-VASc risk score. Previously reported baseline data showed that in Cohort 1, 82.6% of patients had CHA2DS2-VASc ≥2 but only 62% of these patients received anticoagulant therapy.
Data for the stroke-risk stratification research presented at ESC Congress 2013 were available in 5,523 patients enrolled prospectively between December 2009 and October 2011.
The 1-year data - which are preliminary and should be interpreted with caution - were included in one oral presentation and seven poster abstracts. The oral presentation was featured at the State of the Art: Acute coronary syndromes - current guidelines and future prospects, a session that spotlighted the four highest-rated abstract in this topic.
Highlights of the data, which were adjusted for relevant confounding factors, include:
Significantly lower use of VKAs in AF patients with acute coronary syndrome (ACS) vs. those without ACS (48.9% vs. 51.7%, respectively) despite a comparable risk of all-cause death, stroke/systemic embolism (SE), major bleeding and recurrent ACS after 1 year
- 10.1% (n=559) of patients had a history of ACS, 44.0% (n=246) of whom had a history of stenting
AF patients with previous stroke/TIA had a 44% increased risk of death (HR1 1.44, p=0.037) and were more than twice as likely to suffer stroke/SE (HR 2.27, p=0.004) within the first year of diagnosis than patients who had not previously suffered stroke/TIA
More AF patients with previous stroke/TIA received VKAs (58.1% vs. 50.5% for no previous stroke/TIA), though these anticoagulants were markedly underutilised in both groups
Among patients studied, 38.1% (n=2,107) were on rhythm control and 49.8% (n=2,754) were on rate control therapy
AF patients on rhythm control therapy had a 28% lower risk of death (HR 0.72, p=0.041) compared with patients on rate control therapy
Patients on rhythm control were younger and had a lower stroke risk score
The two groups differed in many aspects so there may be some residual confounding variables affecting the findings
19.3% (n=1,066) of the study patients had CAD - these patients were older, more likely to be male, and more likely to receive VKA in combination with antiplatelet (AP) therapy than non-CAD patients
AF patients with CAD had more than twice the risk for ACS than non-CAD patients (HR 2.49, p=0.016) but a comparable risk of death, stroke/SE and major bleeds
24.4% (n=1,348) of study patients had paroxysmal AF vs. 14.2% (n=785) with permanent AF
VKAs, alone or in combination with AP, were used in 39.1% of paroxysmal AF patients and 61.0% of permanent AF patients
Risk of death was 38% lower in patients with paroxysmal vs. permanent AF (HR 0.62, p=0.057)
Stroke/systemic embolism risk was similar in both patient groups (HR=1.18, p=0.72)
28.7% (n=1,587) of patients were enrolled in Asia and 58.6% (n=3,237) were enrolled in Europe Patients in Asia were, on average, more likely to be male, younger, have a lower body mass index and have fewer comorbidities than those in Europe
Regardless of risk level, VKA usage was significantly higher in Europe (61.4%) vs. Asia (35.8%), highlighting substantial differences in the use of available stroke-prevention therapies
44.8% (n=2,477) of patients had new AF vs. 14.2% (n=785) with permanent AF
Use of VKAs, alone or in combination with APs, was lower in patients with new AF (52.1%) vs. permanent AF (61.0%)
Stroke/systemic embolism risk was 47% increased in patients with permanent vs. new AF, though this difference was not statistically significant (HR 1.47, p=0.36)
New AF patients were slightly younger in age
Few patients - 11.1% (n=614) patients - in the registry underwent DCC within four months of diagnosis, even though they were newly diagnosed with AF
Patients undergoing DCC were more likely to receive VKA therapy than patients not undergoing the procedure. However, 6.9% of DCC+ patients received no antithrombotic therapy and 12.5% received only AP
Outcomes of all-cause death, stroke/SE or major bleed at 1 year did not differ between groups
The GARFIELD Registry is an observational, multicentre, international prospective study of men and women with newly diagnosed AF and one or more additional risk factors for stroke. It will prospectively follow 50,000 newly-diagnosed AF patients from at least 1,000 centres in 50 countries in the Americas, Eastern and Western Europe, Asia, Africa and Australia.
GARFIELD is the largest prospective registry of patients with AF at risk of stroke. It seeks to describe the real-life burden of this disease, and provide insights into the impact of thromboembolic and bleeding complications seen in this patient population. It will provide a better understanding of antithrombotic treatment patterns and potential opportunities for improving care and clinical outcomes amongst a representative and diverse group of patients and 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 protocol ensure a comprehensive and representative description of AF:
Included patients have been diagnosed with non-valvular AF within the past six weeks and have at least one additional risk factor for stroke, and as such, are candidates for anticoagulant therapy to prevent blood clots leading to stroke. It will be left to the investigator's clinical judgment to identify patient's stroke risk factor(s). Patients will be included whether or not they receive anticoagulant therapy so current and future treatment strategies and failures can be properly understood in relation to patients' risk profiles and co-morbidities.
Data will be collected over an extended follow-up period of up to 8 years, and will include the following outcomes: thromboembolic stroke; TIA ("mini-strokes"); MI/ACS; blood clots affecting other areas of the body; bleeding events; therapy persistence; rate of discontinuation; medical consultations and hospitalizations; need for urgent and elective interventions; cardiovascular morbidity and all-cause mortality.
Among patients treated with vitamin K antagonists, additional outcomes data will include the frequency and timing of monitoring required to maintain a safe and therapeutically effective level of anticoagulation and interventions needed to manage complications due to anticoagulation therapy.
The GARFIELD Registry is made possible through an unrestricted research grant from Bayer Pharma AG.
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. Ninety-two per cent of fatal strokes are caused by thromboses. People with AF also are at high risk for heart failure, chronic fatigue and other heart rhythm problems.[8,9] Stroke is a major cause of long-term disability worldwide - each year 5 million sufferers are left permanently disabled.
* HR = Hazard Ratio, which is a measure of how often an event occurs (i.e., death) in one group vs. another
(1) Jamil-Copley S, Kanagaratnam P. Stroke in atrial fibrillation-hope on the horizon? J R SOC INTERFACE. 8/16/13.
(2) The Lancet Neurology. Stroke prevention: getting to the heart of the matter. 8/16/13.
(3) Thrombosis Advisor. Thrombosis Facts. 8/16/13.
(4) Chinese Medical Journal 2004; 117 (12): 1763-176. Available here.
(5) European Society of Cardiology. Guidelines for the Management of Atrial Fibrillation. 8/16/13. Available here.
(6) National Heart Lung and Blood Institute. What is Atrial Fibrillation. 8/16/13. Available here.
(7) Thrombosis Research Institute. About Thrombosis. 8/16/13. Available here.
(8) 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.
(9) American Heart Association. Why is AF a problem?. 8/16/13. Available here
(10) World Heart Foundation. The Global Burden of Stroke. 8/16/13. Available here.
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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