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An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol.

ABSTRACT: BACKGROUND:Atrial fibrillation (AF) is an independent risk factor for stroke and a significant predictor of mortality. Evidence-based guidelines for stroke prevention in AF recommend antithrombotic therapy corresponding to the risk of stroke. In practice, many patients with AF do not receive the appropriate antithrombotic therapy and are left either unprotected or inadequately protected against stroke. The purpose of the Global Anticoagulant Registry in the FIELD (GARFIELD) is to determine the real-life management and outcomes of patients newly diagnosed with non-valvular AF. METHODS/DESIGN:GARFIELD is an observational, international registry of newly diagnosed AF patients with at least one additional investigator-defined risk factor for stroke. The aim is to enrol 55,000 patients at more than 1000 centres in 50 countries worldwide. Enrolment will take place in five independent, sequential, prospective cohorts; the first cohort includes a retrospective validation cohort. Each cohort will be followed up for 2 years. The UK stands to be a significant contributor to GARFIELD, aiming to enrol 4,582 patients, and reflecting the care environment in which patients with AF are managed. The UK protocol will also focus on better understanding the validity of the two main stroke risk scores (CHADS2 and CHA2DS2VASC) and the HAS-BLED bleeding risk score, in the context of a diverse patient population. DISCUSSION:The GARFIELD registry will describe how therapeutic strategies, patient care, and clinical outcomes evolve over time. This study will provide UK-specific comprehensive data that will allow a range of evaluations both at a national level and in relation to global data and contribute to a better understanding of AF management in the UK. TRIAL REGISTRATION:ClinicalTrial.gov: NCT01090362.

SUBMITTER: Apenteng PN

PROVIDER: S-EPMC3639953 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol.

Apenteng Patricia N PN Murray Ellen T ET Holder Roger R Hobbs F D Richard FD Fitzmaurice David A DA

BMC cardiovascular disorders 20130423

<h4>Background</h4>Atrial fibrillation (AF) is an independent risk factor for stroke and a significant predictor of mortality. Evidence-based guidelines for stroke prevention in AF recommend antithrombotic therapy corresponding to the risk of stroke. In practice, many patients with AF do not receive the appropriate antithrombotic therapy and are left either unprotected or inadequately protected against stroke. The purpose of the Global Anticoagulant Registry in the FIELD (GARFIELD) is to determi ...[more]

PMID: 23617744

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Project description:BackgroundLimited data are available on the characteristics, clinical management, and outcomes of patients with atrial fibrillation at risk of stroke, from a worldwide perspective. The aim of this study was to describe the baseline characteristics and initial therapeutic management of patients with non-valvular atrial fibrillation across the spectrum of sites at which these patients are treated.Methods and findingsThe Global Anticoagulant Registry in the FIELD (GARFIELD) is an observational study of patients newly diagnosed with non-valvular atrial fibrillation. Enrollment into Cohort 1 (of 5) took place between December 2009 and October 2011 at 540 sites in 19 countries in Europe, Asia-Pacific, Central/South America, and Canada. Investigator sites are representative of the distribution of atrial fibrillation care settings in each country. Cohort 1 comprised 10,614 adults (≥18 years) diagnosed with non-valvular atrial fibrillation within the previous 6 weeks, with ≥1 investigator-defined stroke risk factor (not limited to those in existing risk-stratification schemes), and regardless of therapy. Data collected at baseline included demographics, medical history, care setting, nature of atrial fibrillation, and treatments initiated at diagnosis. The mean (SD) age of the population was 70.2 (11.2) years; 43.2% were women. Mean±SD CHADS2 score was 1.9±1.2, and 57.2% had a score ≥2. Mean CHA2DS2-VASc score was 3.2±1.6, and 8,957 (84.4%) had a score ≥2. Overall, 38.0% of patients with a CHADS2 score ≥2 did not receive anticoagulant therapy, whereas 42.5% of those at low risk (score 0) received anticoagulant therapy.ConclusionsThese contemporary observational worldwide data on non-valvular atrial fibrillation, collected at the end of the vitamin K antagonist-only era, indicate that these drugs are frequently not being used according to stroke risk scores and guidelines, with overuse in patients at low risk and underuse in those at high risk of stroke.Trial registrationClinicalTrials.gov TRI08888.

Project description:The factors influencing three major outcomes-death, stroke/systemic embolism (SE), and major bleeding-have not been investigated in a large international cohort of unselected patients with newly diagnosed atrial fibrillation (AF).In 28,628 patients prospectively enrolled in the GARFIELD-AF registry with 2-year follow-up, we aimed at analysing: (1) the variables influencing outcomes; (2) the extent of implementation of guideline-recommended therapies in comorbidities that strongly affect outcomes. Median (IQR) age was 71.0 (63.0 to 78.0) years, 44.4% of patients were female, median (IQR) CHA2DS2-VASc score was 3.0 (2.0 to 4.0); 63.3% of patients were on anticoagulants (ACs) with or without antiplatelet (AP) therapy, 24.5% AP monotherapy, and 12.2% no antithrombotic therapy. At 2 years, rates (95% CI) of death, stroke/SE, and major bleeding were 3.84 (3.68; 4.02), 1.27 (1.18; 1.38), and 0.71 (0.64; 0.79) per 100 person-years. Age, history of stroke/SE, vascular disease (VascD), and chronic kidney disease (CKD) were associated with the risks of all three outcomes. Congestive heart failure (CHF) was associated with the risks of death and stroke/SE. Smoking, non-paroxysmal forms of AF, and history of bleeding were associated with the risk of death, female sex and heavy drinking with the risk of stroke/SE. Asian race was associated with lower risks of death and major bleeding versus other races. AC treatment was associated with 30% and 28% lower risks of death and stroke/SE, respectively, compared with no AC treatment. Rates of prescription of guideline-recommended drugs were suboptimal in patients with CHF, VascD, or CKD.Our data show that several variables are associated with the risk of one or more outcomes, in terms of death, stroke/SE, and major bleeding. Comprehensive management of AF should encompass, besides anticoagulation, improved implementation of guideline-recommended therapies for comorbidities strongly associated with outcomes, namely CHF, VascD, and CKD.ClinicalTrials.gov NCT01090362.

Project description:OBJECTIVE:To investigate evolving patterns in antithrombotic treatment in UK patients with newly diagnosed non-valvular atrial fibrillation (AF). DESIGN:Prospective, multicentre, international registry. SETTING:186 primary care practices in the UK. PARTICIPANTS:3482 participants prospectively enrolled in four sequential cohorts (cohort 2 (C2) n=830, diagnosed September 2011 to April 2013; cohort 3 (C3) n=902, diagnosed April 2013 to June 2014; cohort 4 (C4) n=850, diagnosed July 2014 to June 2015; cohort 5 (C5) n=900, diagnosed June 2015 to July 2016). Participants had newly diagnosed non-valvular AF and at least one risk factor for stroke, were aged ?18,?and provided informed consent. MAIN OUTCOME MEASURES:Antithrombotic treatment initiated at diagnosis, overall and according to stroke and bleeding risks. Stroke risk was retrospectively calculated using CHA2DS2-VASc (cardiac failure, hypertension, age ?75 (doubled), diabetes, stroke (doubled)-vascular disease, age 65-74 and sex category (female)) and bleeding risk using HAS-BLED (hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, elderly (>65), drugs/alcohol concomitantly (1 point each)). RESULTS:42.7% were women and the mean age was 74.5 years. The median CHA2DS2-VASc score was 3 in all cohorts and the median HAS-BLED score was 2 in all cohorts. There was a statistically significant increase in the use of anticoagulant therapy from C2 to C5 (C2 54.7%, C3 60.3%, C4 73.1%, C5 73.9%; P value for trend <0.0001). The increase in the use of anticoagulant was mainly in patients with CHA2DS2-VASc ?2. The use of vitamin K antagonists (VKAs)±antiplatelet (AP) drugs decreased from C2 to C5 (C2 53.3%, C3 52.1%, C4 50.3%, C5 30.6%), while the use of non-vitamin K antagonist oral anticoagulants (NOACs)±AP increased (C2 1.3%, C3 8.0%, C4 22.7%, C5 43.3%). The use of AP only decreased (C2 36.4%, C3 25.5%, C4 11.9%, C5 10.5%), as did the combination therapy of VKA+AP (C2 13.6%, C3 11.0%, C4 9.6%, C5 5.8%). CONCLUSION:There has been a progressive increase in the proportion of patients newly diagnosed with AF receiving guideline-recommended therapy in the UK, potentially driven by the availability of NOACs. TRIAL REGISTRATION NUMBER:NCT01090362; Pre-results.

Project description:BACKGROUND:The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS:A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION:Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362.

Project description:IntroductionBecause of their high risk of stroke, anticoagulation therapy is recommended for most patients with atrial fibrillation (AF). The present study evaluated the use of anticoagulants in the community and in a hospital setting for patients with AF and its associations with stroke.MethodsPatients admitted with stroke to four major hospitals in County of Surrey, England were surveyed in the 2014-2016 Sentinel Stroke National Audit Programme. Descriptive statistics was used to summarise subject characteristics and ?² test to assess differences between categorical variables.ResultsA total of 3309 patients, 1656 men (mean age: 73.1?years±SD 13.2) and 1653 women (79.3?years±13.0) were admitted with stroke (83.3% with ischaemic, 15.7% haemorrhagic stroke and 1% unspecified). AF occurred more frequently (?2=62.4; p<0.001) among patients admitted with recurrent (30.2%) rather than with first stroke (17.1%). There were 666 (20.1%) patients admitted with a history of AF, among whom 304 (45.3%) were anticoagulated, 279 (41.9%) were untreated and 85 (12.8%) deemed unsuitable for anticoagulation. Of the 453 patients with history of AF admitted with a first ischaemic stroke, 138 (37.2%) were on anticoagulation and 41 (49.6%) were not (?2 = 6.3; p<0.043) and thrombolysis was given more frequently for those without prior anticoagulation treatment (16.1%) or unsuitable for anticoagulation (23.6%) compared with those already on anticoagulation treatment (8.3%; ?2=10.0; p=0.007). Of 2643 patients without a previous history of AF, 171 (6.5%) were identified with AF during hospitalisation. Of patients with AF who presented with ischaemic stroke who were not anticoagulated or deemed unsuitable for anticoagulation prior to admission, 91.8% and 75.0%, respectively, were anticoagulated on discharge.ConclusionsThe study highlights an existing burden for patients with stroke and reflects inadequate treatment of AF which results in an increased stroke burden. There is significant scope to improve the rates of anticoagulation.

Project description:Objective. To investigate the contemporary status of stroke risk profile, antithrombotic treatment, and quality-of-life (QoL) of patients with all types of atrial fibrillation (AF) in China. Design. This is a multicenter, cross-sectional study. Setting. Tertiary (80%) and Tier 2 hospitals (20%) were identified in different economic regions (Northeast, East, West, and Middle) by using a simple random sampling. Participants. A total of 3562 (85.6%) patients with nonvalvular atrial fibrillation (NVAF) and 599 (14.4%) with rheumatic valvular atrial fibrillation (VAF) were consecutively enrolled from 111 hospitals from July 2012 to December 2012. Data Collection. Patient information was collected and QoL was assessed using Short-Form 36 Health Survey (SF-36) questionnaire. Primary and Secondary Outcome Measures. The risk of stroke was assessed using the CHADS2 and CHA2DS2-VASc. QoL was assessed using Medical Outcomes Study SF-36 questionnaire. Results. Overall, 31.7% of the patients received anticoagulant treatment and 61.2% received antiplatelet treatment. The rate of anticoagulant treatment was higher in patients with VAF than in those with NVAF. The anticoagulant use was the lowest in Northeast and the highest in Middle regions. Independent risk factors associated with underuse of anticoagulants for NVAF were age, systolic blood pressure (SBP), non-Middle regions, nontertiary hospitals, and new-onset or paroxysmal AF. For VAF patients, the independent factors were age, paroxysmal AF, treatment in Tier 2 hospitals, SBP, diastolic blood pressure, history of coronary artery disease, and nonreceipt of antiarrhythmic therapy. Patients receiving anticoagulants fared significantly better in some QoL domains than those who received no antithrombotic therapy. Conclusions. These findings suggest that antiplatelet treatment is overused and anticoagulant treatment is underused both in Chinese patients with VAF and NVAF, even though usage of anticoagulants is associated with better QoL. Risk factors with underuse of anticoagulants were not identical in patients with NVAF and VAF.

Dataset Information

An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol.

Publications

An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol.

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