Global Anticoagulant Registry In The FIELD-Atrial Fibrillation Research Articles

Predictors of intracranial hemorrhage in patients with atrial fibrillation treated with oral anticoagulants: Insights from the GARFIELD-AF and ORBIT-AF registries.

An unmet need exists to reliably predict the risk of intracranial hemorrhage (ICH) in patients with atrial fibrillation (AF) treated with oral anticoagulants (OACs). An externally validated model improves ICH risk stratification. Independent factors associated with ICH were identified by Cox proportional hazard modeling, using pooled data from the GARFIELD-AF (Global Anticoagulant Registry in the FIELD-Atrial Fibrillation) and ORBIT-AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) registries. A predictive model was developed and validated by bootstrap sampling and by independent data from the Danish National Patient Register. In the combined training data set, 284 of 53 878 anticoagulated patients had ICH over a 2-year period (0.31 per 100 person-years; 95% confidence interval [CI]: 0.28-0.35). Independent predictors of ICH included: older age, prior stroke or transient ischemic attack, concomitant antiplatelet (AP) use, and moderate-to-severe chronic kidney disease (CKD). Vitamin K antagonists (VKAs) were associated with a significantly higher risk of ICH compared with non-VKA oral anticoagulants (NOACs) (adjusted hazard ratio: 1.61; 95% CI: 1.25-2.08; p = .0002). The ability of the model to discriminate individuals in the training set with and without ICH was fair (optimism-corrected C-statistic: 0.68; 95% CI: 0.65-0.71) and outperformed three previously published methods. Calibration between predicted and observed ICH probabilities was good in both training and validation data sets. Age, prior ischemic events, concomitant AP therapy, and CKD were important risk factors for ICH in anticoagulated AF patients. Moreover, ICH was more frequent in patients receiving VKA compared to NOAC. The new validated model is a step toward mitigating this potentially lethal complication.

GARFIELD-AF: risk profiles, treatment patterns and 2-year outcomes in patients with atrial fibrillation in Germany, Austria and Switzerland (DACH) compared to 32 countries in other regions worldwide.

The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is a worldwide non-interventional study of stroke prevention in patients with non-valvular AF. 52,080 patients with newly diagnosed AF were prospectively enrolled from 2010 to 2016. 4121 (7.9%) of these patients were recruited in DACH [Germany (n = 3567), Austria (n = 465) and Switzerland (n = 89) combined], and 47,959 patients were from 32 countries in other regions worldwide (ORW). Hypertension was most prevalent in DACH and ORW (85.3% and 75.6%, respectively). Diabetes, hypercholesterolaemia, carotid occlusive disease and vascular disease were more prevalent in DACH patients vs ORW (27.6%, 49.4%, 5.8% and 29.0% vs 21.7%, 40.9%, 2.8% and 24.5%). The use of non-vitamin K antagonist oral anticoagulants (NOACs) increased more in DACH over time. Management of vitamin K antagonists was suboptimal in DACH and ORW (time in therapeutic range of INR ≥ 65% in 44.6% and 44.4% of patients or ≥ 70% in 36.9% and 36.0% of patients, respectively). Adjusted rates of cardiovascular mortality and MI/ACS were higher in DACH while non-haemorrhagic stroke/systemic embolism was lower after 2-year follow-up. Similarities and dissimilarities in AF management and clinical outcomes are seen in DACH and ORW. The increased use of NOAC was associated with a mismatch of risk-adapted anticoagulation (over-and-undertreatment) in DACH. Suboptimal control of INR requires educational activities in both regional groups. Higher rates of cardiovascular death in DACH may reflect the higher risk profile of these patients and lower rates of non-haemorrhagic stroke could be associated with increased NOAC use.

Use of anticoagulant drugs in patients with atrial fibrillation. Does adherence to therapy have a prognostic impact?

Anticoagulant therapy represents a pivotal element that strongly influences the thromboembolic risk of non-valvular atrial fibrillation (NVAF) subjects. The main purpose of this review was to identify issues and suggest strategies to improve the oral anticoagulants (OACs) treatment adherence, which is the most important predictor of NVAF outcome. Advantages, efficacy, and impact of these drugs on patients' prognosis were revealed in important clinical trials on large cohorts of patients and are often prescribed nowadays. A real-life data registry, the Global Anticoagulant Registry in the Field-Atrial Fibrillation (GARFIELD-AF) analyzed the profile and outcome of patients diagnosed with NVAF receiving oral antithrombotic treatment. The observations gathered in the registry were crucial for identifying relevant elements that clinicians must improve, such as adherence strategies and predisposing factors that correlated with stroke. Adherence to OACs in AF patients is essential from the viewpoint of clinical efficacy and safety. Major adverse events and negative outcome are correlated with a weak anticoagulation control caused by an ineffective treatment adherence strategy. Solving the issue of oral anticoagulation adherence is possible using new technologies, but future directions should be explored. Mobile phone applications centered on patients' needs, telemedicine programs that evaluate patients' evolution and detect adverse reactions or events, encouraging an adequate management of the event without interruption of OACs, represent perspectives with a major impact on treatment adherence.

A treatment-specific marginal structural Cox model for the effect of treatment discontinuation.

Patients taking a prescribed medication often discontinue their treatment; however, this may negatively impact their health outcomes. If doctors had statistical evidence that discontinuing some prescribed medication shortened, on average, the time to a clinical event (e.g., death), they could use that knowledge to encourage their patients to stay on the prescribed treatment. We describe a treatment‐specific marginal structural Cox model for estimation of the causal effect of treatment discontinuation on a survival endpoint. The effect of treatment discontinuation is quantified by the hazard ratio of the event hazard rate had the population followed the regime “take treatment a until it is discontinued at some time ν,” versus the event hazard rate had the population never discontinued treatment a. Valid causal analysis requires control for treatment confounding, regime confounding, and censoring due to regime violation. We propose new inverse probability of regime compliance weights to address the three issues simultaneously. We apply the framework to data from the Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD‐AF) study. Patients from this study are treated with one of two types of oral anticoagulants (OACs). We test whether the causal effect of treatment discontinuation differs by type of OAC, and we also estimate the size and direction of the effect. We find evidence that OAC discontinuation increases the hazard for certain events, but we do not find evidence that this effect differs by treatment.

Comparing rivaroxaban and apixaban in GARFIELD-AF according to ROCKET AF and ARISTOTLE trial selection criteria

Abstract Introduction There is debate on the extent to which differences in selection criteria and outcome definitions used for ARISTOTLE and ROCKET AF – the trials for the approval of apixaban and rivaroxaban, respectively, for non-valvular atrial fibrillation – influenced their differences in outcomes relative to vitamin K antagonists (VKAs). In absence of randomized trials comparing the two non-vitamin K oral antagonists (NOACs) directly, this question can be addressed using data from the Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) registry, a large, high-quality prospective observational study of newly diagnosed AF patients. Purpose To assess the influence of the ARISTOTLE and ROCKET AF inclusion and exclusion criteria on results for safety and efficacy of apixaban and rivaroxaban versus VKA using uniform endpoints in GARFIELD-AF. Methods We selected patients treated with apixaban, rivaroxaban or VKA from GARFIELD-AF who were eligible for ARISTOTLE or ROCKET AF as per the original trial criteria. We replicated the inclusion criteria in the GARFIELD-AF population and derived those eligible for each trial. We calculated the adjusted hazard ratios (HRs) for stroke or systemic embolism, major bleeding and all-cause mortality within 2 years of enrolment for apixaban as well as rivaroxaban versus VKA (reference) in those eligible for each trial. We used a propensity score overlap weighted Cox model to emulate trial randomization between NOAC and VKA. Results Among patients on apixaban, rivaroxaban and VKA, 2570/3615 (71%), 3560/4914 (72%) and 8005/11734 (71%) were eligible for ARISTOTLE, respectively, and 1612/3615 (45%), 2005/4914 (41%) and 4368/11734 (37%), respectively, were eligible for ROCKET AF. Cardiovascular co-morbidity was greater in those eligible for ROCKET AF than in those eligible for ARISTOTLE. In patients selected using the more restrictive ROCKET AF criteria, apixaban and rivaroxaban users showed similar results when compared with VKA (see Figure). The two sets of comparisons remained non-significant in difference when applying the less restrictive ARISTOTLE criteria, but there were trends for less similarity. Conclusion Apixaban showed similar results to rivaroxaban when selecting for higher-risk patients using the ROCKET AF criteria. In patients selected using ARISTOTLE criteria the similarity was less pronounced. Our results underline the problems faced in comparing treatments across rather than within clinical trials. For instance, co-morbidities were substantially different for patients recruited into the original ARISTOTLE and ROCKET AF trials. The current work points to the need for high-quality observational data for assessment of relative drug performance in absence of direct drug comparisons through randomized trials. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This work was supported by an unrestricted research grant from Bayer AG, Berlin, Germany, to TRI, London, UK, which sponsors the GARFIELD-AF registry. This work is supported by KANTOR CHARITABLE FOUNDATION for the Kantor-Kakkar Global Centre for Thrombosis Science.

Safety and efficacy of apixaban and rivaroxaban versus warfarin in real-world atrial fibrillation patients are similar to their randomized trials: insights from GARFIELD-AF registry

Abstract Introduction Generalisability of patient selection in the landmark trials for the approval of apixaban (ARISTOTLE) and rivaroxaban (ROCKET AF) for use in non-valvular atrial fibrillation (AF) is limited. Although observational data have confirmed the safety and efficacy of these non-vitamin K oral anticoagulants (NOACs) in unselected AF populations, robust replication of randomized trials in observational studies is warranted. Purpose To investigate the proportion of real-world AF patients who would have been eligible for the landmark trials for ARISTOTLE and ROCKET AF, and to assess reproducibility of these landmark trials in the largest, worldwide, prospective registry of newly diagnosed AF patients. Methods We analysed data from the Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) registry. We assessed the eligibility of AF patients treated with apixaban or vitamin K antagonist (VKA) for ARISTOTLE, and those treated with rivaroxaban or VKA for ROCKET AF, using the selection criteria of the original trials. We replicated the inclusion and exclusion criteria of ARISTOTLE and ROCKET AF by deriving the set of patients eligible for each trial and calculating the adjusted hazard ratios (HRs) for stroke or systemic embolism, major bleeding, and all-cause mortality within 2 years of enrolment, using a propensity score overlap weighted Cox model. We compared the results from observational data with those reported in the original ARISTOTLE and ROCKET AF publications. Results Among all patients enrolled in GARFIELD-AF, 67% were eligible for recruitment in ARISTOTLE and 37% in ROCKET AF. The corresponding proportions among anticoagulated patients were 70% and 39%, respectively. Among patients on apixaban and VKA, 2570/3615 (71%) and 8005/11718 (68%), respectively, were eligible for ARISTOTLE. Of patients using rivaroxaban and VKA, 2005/4914 (41%) and 4368/11721 (37%), respectively, were eligible for ROCKET AF. Annual eligibility rates among real-world NOAC users were stable over time (Figure 1). Registry participants on rivaroxaban or VKA eligible for ROCKET AF had a higher burden of cardiovascular co-morbidity than those on apixaban or VKA eligible for ARISTOTLE. The adjusted HRs in observational data were compatible with results of the original trials in all selected outcomes (Figure 2). Conclusion Representativeness of ARISTOTLE and ROCKET AF for real-world AF populations was limited, with ROCKET AF's criteria being more restrictive. Despite inclusion of only incident AF cases in GARFIELD-AF versus mostly prevalent AF cases in the original trials, the results were similar. Our work indicates that the results from ARISTOTLE and ROCKET AF appear robust and reproducible in real-world patients with newly diagnosed AF. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This work was supported by an unrestricted research grant from Bayer AG, Berlin, Germany, to TRI, London, UK, which sponsors the GARFIELD-AF registry. This work is supported by KANTOR CHARITABLE FOUNDATION for the Kantor-Kakkar Global Centre for Thrombosis Science.

GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation

AimsTo determine whether the Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) integrated risk tool predicts mortality, non-haemorrhagic stroke/systemic embolism, and major bleeding for up to 2 years after new-onset AF and to assess how this risk tool performs compared with CHA2DS2-VASc and HAS-BLED.Methods and resultsPotential predictors of events included demographic and clinical characteristics, choice of treatment, and lifestyle factors. A Cox proportional hazards model was identified for each outcome by least absolute shrinkage and selection operator methods. Indices were evaluated in comparison with CHA2DS2-VASc and HAS-BLED risk predictors. Models were validated internally and externally in ORBIT-AF and Danish nationwide registries. Among the 52 080 patients enrolled in GARFIELD-AF, 52 032 had follow-up data. The GARFIELD-AF risk tool outperformed CHA2DS2-VASc for all-cause mortality in all cohorts. The GARFIELD-AF risk score was superior to CHA2DS2-VASc for non-haemorrhagic stroke, and it outperformed HAS-BLED for major bleeding in internal validation and in the Danish AF cohort. In very low- to low-risk patients [CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)], the GARFIELD-AF risk score offered strong discriminatory value for all the endpoints when compared to CHA2DS2-VASc and HAS-BLED. The GARFIELD-AF tool also included the effect of oral anticoagulation (OAC) therapy, thus allowing clinicians to compare the expected outcome of different anticoagulant treatment decisions [i.e. no OAC, non-vitamin K antagonist (VKA) oral anticoagulants, or VKAs].ConclusionsThe GARFIELD-AF risk tool outperformed CHA2DS2-VASc at predicting death and non-haemorrhagic stroke, and it outperformed HAS-BLED for major bleeding in overall as well as in very low- to low-risk group patients with AF.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF: NCT01090362, ORBIT-AF I: NCT01165710; ORBIT-AF II: NCT01701817.

Bleeding and related mortality with NOACs and VKAs in newly diagnosed atrial fibrillation: results from the GARFIELD-AF registry

In atrial fibrillation (AF), lower risks of death and bleeding with non-vitamin-K oral anticoagulants (NOACs) were reported in meta-analyses of controlled trials, but whether these findings hold true in real-world practice remains uncertain. Risks of bleeding and death were assessed in 52 032 patients with newly diagnosed AF enrolled in GARFIELD-AF (Global Anticoagulant Registry in the FIELD–Atrial Fibrillation), a worldwide prospective registry. Baseline treatment was vitamin K antagonists (VKAs) with or without antiplatelet (AP) agents (VKA ± AP) (20 151; 39.3%), NOACs ± AP agents (14 103; 27.5%), AP agents only (10 748; 21.0%), or no antithrombotics (6219; 12.1%). One-year follow-up event rates (95% confidence interval [CI]) of minor, clinically relevant nonmajor (CRNM), and major bleedings were 2.29 (2.16-2.43), 1.10 (1.01-1.20), and 1.31 (1.21-1.41) per 100 patient-years, respectively. Bleeding risk was lower with NOACs than VKAs for any bleeding (hazard ratio (HR) [95% CI]), 0.85 [0.73-0.98]) or major bleeding (0.79 [0.60-1.04]). Compared with no bleeding, the risk of death was higher with minor bleeding (adjusted HR [aHR], 1.53 [1.07-2.19]), CRNM bleeding (aHR, 2.59 [1.80-3.73]), and major bleeding (aHR, 8.24 [6.76-10.04]). The all-cause mortality rate was lower with NOACs than with VKAs (aHR, 0.73 [0.62-0.85]). Forty-five percent (114) of all deaths occurred within 30 days, and 40% of these were from intracranial/intraspinal hemorrhage (ICH). The rates of any bleeding and all-cause death were lower with NOACs than with VKAs. Major bleeding was associated with the highest risk of death. CRNM bleeding and minor bleeding were associated with a higher risk of death compared to no bleeding. Death within 30 days after a major bleed was most frequently related to ICH. This trial was registered at www.clinicaltrials.gov as #NCT01090362.

Characteristics, treatment, and outcomes of newly diagnosed atrial fibrillation patients with heart failure: GARFIELD-AF.

AimsHeart failure (HF) and atrial fibrillation (AF) may coexist and influence each other. However, characteristics, anticoagulant treatment, and outcomes of contemporary AF patients with concurrent HF are ill‐defined. This study analyses characteristics, treatment, and 2 year outcomes in newly diagnosed Global Anticoagulant Registry in the FIELD‐Atrial Fibrillation (GARFIELD‐AF) patients with vs. without HF.Methods and resultsGARFIELD‐AF is the world's largest observational AF patient study. At enrolment, 11 758 of 52 072 patients (22.6%) had HF; 76.3% were New York Heart Association class II–III. Patients with HF had comparable demographics, blood pressure, and heart rate but more likely had permanent (15.6% vs. 11.9%) or persistent AF (18.9% vs. 13.8%), acute coronary syndromes (16.7% vs. 8.9%), vascular disease (40.8% vs. 20.2%), and moderate‐to‐severe chronic kidney disease (14.6% vs. 9.0%) than those without. Anticoagulant prescription was similar between the two groups. At 2 year follow‐up, patients with HF showed a greater risk of all‐cause mortality [hazard ratio (HR), 2.06; 95% confidence interval (CI), 1.91–2.21; P < 0.0001], cardiovascular mortality (HR, 2.91; 95% CI, 2.58–3.29; P < 0.0001), acute coronary syndromes (HR, 1.25; 95% CI, 1.02–1.52; P = 0.03), and stroke/systemic embolism (HR, 1.24; 95% CI, 1.07–1.43; P = 0.0044). Major bleeding rate was comparable (adjusted HR, 1.00; 95% CI, 0.84–1.18; P = 0.968). Among patients without HF at baseline, incidence of new HF was low [0.69 (95% CI, 0.63–0.75) per 100 person‐years], whereas propensity to develop worsening HF was higher in those with HF [1.62 (95% CI, 1.45–1.80) per 100 person‐years].ConclusionsPatients with AF and HF have a high risk of all‐cause and cardiovascular mortality and stroke/systemic embolism and may develop worsening HF.

GARFIELD-AF: a worldwide prospective registry of patients with atrial fibrillation at risk of stroke.

The Global Anticoagulant Registry in the Field-Atrial Fibrillation (GARFIELD-AF) examined real-world practice in a total of 57,149 (5069 retrospective, 52,080 prospective) patients with newly diagnosed AF at risk of stroke/systemic embolism, enrolled at over 1000 centers in 35 countries. It aimed to capture data on AF burden, patients' clinical profile, patterns of clinical practice and antithrombotic management, focusing on stroke/systemic embolism prevention, uptake of new oral anticoagulants, impact on death and bleeding. GARFIELD-AF set new standards for quality of data collection and analysis. A total of 36 peer-reviewed articles were already published and 73 abstracts presented at international congresses, covering treatment strategies, geographical variations in baseline risk and therapies, adverse outcomes and common comorbidities such as heart failure. A risk prediction tool as well as innovative observational studies and artificial intelligence methodologies are currently being developed by GARFIELD-AF researchers. Clinical Trial Registration: NCT01090362 (ClinicalTrials.gov).

Impact of oral anticoagulation in patients with atrial fibrillation at very low thromboembolic risk

ObjectiveTo investigate reasons for and impact of oral anticoagulation (OAC) in patients with atrial fibrillation (AF) at very low thromboembolic risk.MethodsIndividuals with CHA2DS2-VASc score 0 (men) or 1 (women) from...

GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study

ObjectivesTo externally validate the accuracy of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) model against existing risk scores for stroke and major bleeding risk in patients with non-valvular...

Predictors of NOAC versus VKA use for stroke prevention in patients with newly diagnosed atrial fibrillation: Results from GARFIELD-AF

A principal aim of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) was to document changes in treatment practice for patients with newly diagnosed atrial fibrillation during an era when non-vitamin K antagonist oral anticoagulants (NOACs) were becoming more widely adopted. In these analyses, the key factors which determined the choice between NOACs and vitamin K antagonists (VKAs) are explored. Logistic least absolute shrinkage and selection operator regression determined predictors of NOAC and VKA use. Data were collected from 24,137 patients who were initiated on AC ± antiplatelet (AP) therapy (NOAC [51.4%] or VKA [48.6%]) between April 2013 and August 2016. The most significant predictors of AC therapy were country, enrolment year, care setting at diagnosis, AF type, concomitant AP, and kidney disease. Patients enrolled in emergency care or in the outpatient setting were more likely to receive a NOAC than those enrolled in hospital (OR 1.16 [95% CI: 1.04-1.30], OR: 1.15 [95% CI: 1.05-1.25], respectively). NOAC prescribing seemed to be favored in lower-risk groups, namely, patients with paroxysmal AF, normotensive patients, and those with moderate alcohol consumption, but also the elderly and patients with acute coronary syndrome. By contrast, VKAs were preferentially used in patients with permanent AF, moderate to severe kidney disease, heart failure, vascular disease, and diabetes and with concomitant AP. GARFIELD-AF data highlight marked heterogeneity in stroke prevention strategies globally. Physicians are adopting an individualized approach to stroke prevention where NOACs are favored in patients with a lower stroke risk but also in the elderly and patients with acute coronary syndrome.

Management and 1-Year Outcomes of Patients With Newly Diagnosed Atrial Fibrillation and Chronic Kidney Disease: Results From the Prospective GARFIELD - AF Registry.

BackgroundUsing data from the GARFIELD‐AF (Global Anticoagulant Registry in the FIELD–Atrial Fibrillation), we evaluated the impact of chronic kidney disease (CKD) stage on clinical outcomes in patients with newly diagnosed atrial fibrillation (AF).Methods and Results GARFIELD‐AF is a prospective registry of patients from 35 countries, including patients from Asia (China, India, Japan, Singapore, South Korea, and Thailand). Consecutive patients enrolled (2013–2016) were classified with no, mild, or moderate‐to‐severe CKD, based on the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative guidelines. Data on CKD status and outcomes were available for 33 024 of 34 854 patients (including 9491 patients from Asia); 10.9% (n=3613) had moderate‐to‐severe CKD, 16.9% (n=5595) mild CKD, and 72.1% (n=23 816) no CKD. The use of oral anticoagulants was influenced by stroke risk (ie, post hoc assessment of CHA 2 DS 2‐VASc score), but not by CKD stage. The quality of anticoagulant control with vitamin K antagonists did not differ with CKD stage. After adjusting for baseline characteristics and antithrombotic use, both mild and moderate‐to‐severe CKD were independent risk factors for all‐cause mortality. Moderate‐to‐severe CKD was independently associated with a higher risk of stroke/systemic embolism, major bleeding, new‐onset acute coronary syndrome, and new or worsening heart failure. The impact of moderate‐to‐severe CKD on mortality was significantly greater in patients from Asia than the rest of the world (P=0.001).ConclusionsIn GARFIELD‐AF, moderate‐to‐severe CKD was independently associated with stroke/systemic embolism, major bleeding, and mortality. The effect of moderate‐to‐severe CKD on mortality was even greater in patients from Asia than the rest of the world.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362.

Antithrombotic treatment patterns and stroke prevention in patients with atrial fibrillation in TURKEY: inferences from GARFIELD-AF registry

Objective:The corner stone of atrial fibrillation therapy includes the prevention of stroke with less adverse effects. The Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) study provided data to compare treatment strategies in Turkey with other populations and every-day practice of stroke prevention management with complications.Methods:GARFIELD-AF is a large-scale registry that enrolled 52,014 patients in five sequential cohorts at >1.000 centers in 35 countries. This study was initiated to track the evolution of global anticoagulation practice, and to study the impact of NOAC therapy in AF. A total of 756 patients from 17 enrolling sites in Turkey were in cohort 4 and 5. Treatment strategies at diagnosis initiated by CHA2DS2-VASc score, baseline characteristics of patients, treatment according to stroke and bleeding risk profiles, and INR values were analyzed in cohorts. Additionally, event rates during the first year follow up were evaluated.Results:AF patients in Turkey were mostly seen in young women. Stroke risk according to the CHADS2 score and CHA2DS2-VASc score compared with world data. The mean of risk score values, including HAS-BLED score were lower in Turkey than in the world data. The percentage of patients receiving FXa inhibitor with or without an antiplatelet usage was more than the other drug groups. All-cause mortality was higher in Turkey. Different form world data when HAS-BLED score was above 3, the therapy was mostly changed to antiplatelet drugs in Turkey.Conclusion:In addition to deficiencies in available treatment options, patient care and clinical outcomes of patients with AF, the data of GARFIELD-AF provide data from Turkey about therapeutic strategies and best practices.

Treatment patterns in anticoagulant therapy in patients with newly diagnosed atrial fibrillation in Belgium: results from the GARFIELD-AF registry

Background: AF, anticoagulation, NOACs, changing patterns of prescription.Methods: We describe baseline data and treatment patterns of patients recruited in Belgium in the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF). Recruitment began when novel oral anticoagulants (NOACs) were introduced and provides a unique picture of changing treatment patterns over time. 1713 patients with a new (≤6 weeks duration) diagnosis of non-valvular atrial fibrillation (NVAF) and at least one investigator-defined stroke risk factor were recruited between May 2012 and August 2016, and will be prospectively followed for at least 2 years.Results: Overall, anticoagulant use in Belgium was higher than in the rest of Europe: 80.1% of patients received an anticoagulant ± antiplatelet (AP) therapy (14.5% on vitamin K antagonists; 65.6% on NOAC), 10.7% AP therapy and 9.3% no antithrombotic therapy. Over time, we observed an increase in anticoagulant use and a decrease in AP use for stroke prevention. NOAC use in Belgium was the highest of Europe at the study start, with many countries catching up later. In high stroke risk patients (CHA2DS2-VASc ≥2), anticoagulants were used in 84.3%, leaving 15.7% unprotected. In low risk patients (CHA2DS2-VASc 0-1) anticoagulants were overused (58.7%). Factor Xa inhibitors were used more frequently than direct thrombin inhibitors.Conclusion: Guideline adherence on stroke prevention was higher in Belgium than in the rest of Europe, and increased over time. NOAC use in Belgium was the highest of Europe at the study start, with many countries catching up later. Possible reasons are discussed.Clinical Trial Registration:http://www.clinicaltrials.gov. Unique identifier: NCT01090362.

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry

BackgroundThe 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 resultsA 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. ConclusionCompared 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—URLhttp://www.clinicaltrials.gov. Unique identifier: NCT01090362.

Why are outcomes different for registry patients enrolled prospectively and retrospectively? Insights from the global anticoagulant registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0 and 18 months (such that the total time of follow-up was 24 months; data collection December 2009 and October 2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between March 2010 and October 2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs. 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51-3.67] vs. 4.05 [95% CI 3.53-4.63]; P = 0.016). Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF (NCT01090362).

EARLY MORTALITY IN PATIENTS WITH NEW ONSET ATRIAL FIBRILLATION: RESULTS FROM THE GARFIELD-AF REGISTRY

Background: Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is a non-interventional study which, like Framingham Heart Study, provides a record of early events from the time of diagnosis of nonvalvular atrial fibrillation (AF). Patients were enrolled in GARFIELD-AF an

Evolving quality standards for large-scale registries: the GARFIELD-AF experience.

Registries have the potential to capture treatment practices and outcomes in populations beyond the constraints of clinical trial settings. The value of data obtained depend critically upon robust quality standards (including source data verification [SDV] and training); features that are commonly absent from registries. This article outlines the quality standards developed for Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF). GARFIELD-AF comprises ∼57000 patients prospectively recruited over 6.5years in 35 countries in five successive cohorts. The registry employs a combination of remote and onsite monitoring to ascertain completeness and accuracy of records and by design, SDV is performed on 20% of cases (i.e. ∼11400 patients). Four performance measures for ranking sites according to data quality and other performance indicators were evaluated (including data quality for 13 quantifiable variables, late data locking, number of missing critical variables, and history of poor data quality from the previous monitoring phase). These criteria facilitated the identification of sites with potentially suboptimal data quality for onsite monitoring. During early phases of the registry, critical variables for data checking were also identified. SDV using these variables (partial SDV in 902 patients) showed similar concordance to SDV of all fields (110 patients): 94.4% vs. 93.1%, respectively. This standard formed the baseline against which ongoing quality improvements were assessed, facilitating corrective action on data quality issues. In consequence, concordance was improved in the next monitoring phase (95.6%; n = 1172). The quality standards in GARFIELD-AF have the potential to inform a future 'reference' for registries.