37 research outputs found

    Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

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    Background: 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. Methods and Results: 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 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-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 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: 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. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

    Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation.

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    OBJECTIVES: To provide an accurate, web-based tool for stratifying patients with atrial fibrillation to facilitate decisions on the potential benefits/risks of anticoagulation, based on mortality, stroke and bleeding risks. DESIGN: The new tool was developed, using stepwise regression, for all and then applied to lower risk patients. C-statistics were compared with CHA2DS2-VASc using 30-fold cross-validation to control for overfitting. External validation was undertaken in an independent dataset, Outcome Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). PARTICIPANTS: Data from 39 898 patients enrolled in the prospective GARFIELD-AF registry provided the basis for deriving and validating an integrated risk tool to predict stroke risk, mortality and bleeding risk. RESULTS: The discriminatory value of the GARFIELD-AF risk model was superior to CHA2DS2-VASc for patients with or without anticoagulation. C-statistics (95% CI) for all-cause mortality, ischaemic stroke/systemic embolism and haemorrhagic stroke/major bleeding (treated patients) were: 0.77 (0.76 to 0.78), 0.69 (0.67 to 0.71) and 0.66 (0.62 to 0.69), respectively, for the GARFIELD-AF risk models, and 0.66 (0.64-0.67), 0.64 (0.61-0.66) and 0.64 (0.61-0.68), respectively, for CHA2DS2-VASc (or HAS-BLED for bleeding). In very low to low risk patients (CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)), the CHA2DS2-VASc and HAS-BLED (for bleeding) scores offered weak discriminatory value for mortality, stroke/systemic embolism and major bleeding. C-statistics for the GARFIELD-AF risk tool were 0.69 (0.64 to 0.75), 0.65 (0.56 to 0.73) and 0.60 (0.47 to 0.73) for each end point, respectively, versus 0.50 (0.45 to 0.55), 0.59 (0.50 to 0.67) and 0.55 (0.53 to 0.56) for CHA2DS2-VASc (or HAS-BLED for bleeding). Upon validation in the ORBIT-AF population, C-statistics showed that the GARFIELD-AF risk tool was effective for predicting 1-year all-cause mortality using the full and simplified model for all-cause mortality: C-statistics 0.75 (0.73 to 0.77) and 0.75 (0.73 to 0.77), respectively, and for predicting for any stroke or systemic embolism over 1 year, C-statistics 0.68 (0.62 to 0.74). CONCLUSIONS: Performance of the GARFIELD-AF risk tool was superior to CHA2DS2-VASc in predicting stroke and mortality and superior to HAS-BLED for bleeding, overall and in lower risk patients. The GARFIELD-AF tool has the potential for incorporation in routine electronic systems, and for the first time, permits simultaneous evaluation of ischaemic stroke, mortality and bleeding risks. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF (NCT01090362) and for ORBIT-AF (NCT01165710)

    Two-year outcomes of patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF.

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    AIMS: The relationship between outcomes and time after diagnosis for patients with non-valvular atrial fibrillation (NVAF) is poorly defined, especially beyond the first year. METHODS AND RESULTS: GARFIELD-AF is an ongoing, global observational study of adults with newly diagnosed NVAF. Two-year outcomes of 17 162 patients prospectively enrolled in GARFIELD-AF were analysed in light of baseline characteristics, risk profiles for stroke/systemic embolism (SE), and antithrombotic therapy. The mean (standard deviation) age was 69.8 (11.4) years, 43.8% were women, and the mean CHA2DS2-VASc score was 3.3 (1.6); 60.8% of patients were prescribed anticoagulant therapy with/without antiplatelet (AP) therapy, 27.4% AP monotherapy, and 11.8% no antithrombotic therapy. At 2-year follow-up, all-cause mortality, stroke/SE, and major bleeding had occurred at a rate (95% confidence interval) of 3.83 (3.62; 4.05), 1.25 (1.13; 1.38), and 0.70 (0.62; 0.81) per 100 person-years, respectively. Rates for all three major events were highest during the first 4 months. Congestive heart failure, acute coronary syndromes, sudden/unwitnessed death, malignancy, respiratory failure, and infection/sepsis accounted for 65% of all known causes of death and strokes for <10%. Anticoagulant treatment was associated with a 35% lower risk of death. CONCLUSION: The most frequent of the three major outcome measures was death, whose most common causes are not known to be significantly influenced by anticoagulation. This suggests that a more comprehensive approach to the management of NVAF may be needed to improve outcome. This could include, in addition to anticoagulation, interventions targeting modifiable, cause-specific risk factors for death. 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.

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    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

    Sex-specific predictors of left ventricular diastolic dysfunction in untreated hypertension

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    Joanna Jaroch,1 Olga Vriz,2 Zbigniew Bociąga,1 Caterina Driussi,2 Maria Łoboz-Rudnicka,1 Barbara Rzyczkowska,1 Krystyna Łoboz-Grudzień1,3 1Department of Cardiology, T&nbsp;Marciniak Hospital, Wroclaw, Poland; 2Division of Cardiology, San&nbsp;Antonio Hospital, San Daniele del&nbsp;Friuli, Udine, Italy; 3Health Science&nbsp;Faculty, Wroclaw Medical University, Wroclaw, PolandBackground: Little is known about the sex-specific differences in left ventricular (LV) diastolic dysfunction (DD) predictors. We hypothesized that arterial stiffness (AS) may play a different role in the etiology of LV DD in hypertensive men and postmenopausal women, acting independently from other established predictors of this condition, such as age, obesity, diabetes mellitus, LV remodeling, and systolic function.Objectives: The aim of the study was to analyze the sex-specific differences in AS and other predictors of LV DD in men and postmenopausal women with untreated hypertension (HTN).Patients and methods: The study included 144 patients (63 postmenopausal women and 81&nbsp;men, mean age 62.7&plusmn;6.7 years) with previously untreated HTN and no history of cardiovascular diseases. All patients were subjected to detailed echocardiography, vascular ultrasound, and high-resolution echotracking (eTracking) of carotid arteries.Results: In the multivariate analysis, concomitant diabetes mellitus turned out to be an independent predictor of LV DD in women (P=0.02). In turn, two independent predictors of LV DD have been identified in men: S&#39;-tissue Doppler-derived peak LV longitudinal systolic shortening velocity (P=0.001) and &beta;, beta stiffness index (P=0.004).Conclusion: There are sex differences in the predictors of LV DD in untreated HTN. In postmenopausal women, LV DD is mostly determined by diabetes, while in men, it is determined by S&#39;, reflecting LV systolic longitudinal function, and &beta;, a parameter of AS. Keywords: sex differences, left ventricular diastolic dysfunction, hypertensio

    Gender-related differences in the progression of carotid stiffness with age and in the influence of risk factors on carotid stiffness

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    Maria Łoboz-Rudnicka,1 Joanna Jaroch,1 Ewa Kruszyńska,1 Zbigniew Bociąga,1 Barbara Rzyczkowska,1 Krzysztof Dudek,2 Andrzej Szuba,3 Krystyna Łoboz-Grudzień1,4 1Department of Cardiology, T. Marciniak Hospital, Wrocław, Poland; 2Faculty of Mechanical Engineering, Wrocław University of Technology, Wrocław, Poland; 3Division of Angiology, Wrocław Medical University, Wrocław, Poland; 4Public Health Department, Wrocław Medical University, Wrocław, Poland Background: In recent years, there has been growing interest in the impact of gender-related factors on the function and structure of the arterial tree. The aim of our study was to identify gender-specific differences in the progression of carotid stiffness parameters with age and in the impact of risk factors on carotid stiffness. Subjects and methods: The study group included 256 subjects (mean age: 54.7 years): 134 women (52%) and 122 men (48%) with cardiovascular risk factors: hypertension, type 2 diabetes mellitus, dyslipidemia, smoking, and obesity. Local parameters of carotid stiffness: &beta; stiffness index (&beta;), Peterson&rsquo;s elastic modulus (Ep), pulse wave velocity &beta; (PWV-&beta;) and arterial compliance (AC) were determined with ultrasound echo-tracking software application. Results: Women were characterized by lower AC than men (women: 0.57 mm2/kPa vs men: 0.69 mm2/kPa, p &lt; 0.001) and the subanalysis in three age groups revealed that the difference in AC value between genders became significant over the age of 45 years. Although no significant difference in the value of &beta;, Ep and PWV-&beta; were found between genders in the whole study group, women &lt;45 years were characterized by lower values of &beta; and Ep than their men counterparts (&beta;: women: 5.4 vs men: 6.6, p = 0.002; Ep: women: 72 kPa vs men: 84 kPa, p = 0.015). Among analyzed risk factors, the significant determinants of carotid stiffness were age, blood pressure components (pulse pressure and mean arterial pressure), type 2 diabetes mellitus and heart rate. The relationship between carotid stiffness and pulse pressure was observed only in women and between carotid stiffness and heart rate &ndash; only in men. Conclusion: There are gender-related differences in the progression of carotid stiffness parameters with age and in the influence of risk factors on carotid stiffness. Keywords: arterial stiffness, gender, risk factors, arterial remodelin

    Impact of cardiovascular risk factors on carotid intima&ndash;media thickness: sex differences

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    Maria Łoboz-Rudnicka,1 Joanna Jaroch,1 Zbigniew Bociąga,1 Barbara Rzyczkowska,1 Izabella Uchmanowicz,2 Jacek Polański,3 Krzysztof Dudek,4 Andrzej Szuba,5 Krystyna Łoboz-Grudzień2&nbsp;&nbsp; 1Department of Cardiology, T. Marciniak Hospital, 2Public Health Department, Wroclaw Medical University, 3Private Practice, Na Biskupinie, Wroclaw, 4Faculty of Mechanical Engineering, Wroclaw University of Technology, 5Division of Angiology, Wroclaw Medical University, Wroclaw, Poland Background and purpose: There has been growing interest in the sex-related differences in the impact of cardiovascular (CV) risk factors on carotid intima&ndash;media thickness (CIMT). Therefore, we aimed at examining the influence of CV risk factors on CIMT in men and women and identifying differences between males and females in the risk profiles affecting CIMT. Patients and methods: The study group consisted of 256 patients (mean age 54.7&nbsp;years), including 134 females (52%), with the following CV risk factors: arterial hypertension, type 2 diabetes mellitus, dyslipidemia, nicotine addiction, overweight, and obesity. Subjects with the history of any overt CV disease were excluded. CIMT was measured through B-mode ultrasound examination of the right common carotid artery. In the analysis of CIMT values at different ages, the patients were divided into three age groups: 1) &lt;45&nbsp;years, 2) 45&ndash;60&nbsp;years, and 3) &gt;60&nbsp;years. Regression analysis was used to examine the influence of CV risk factors on CIMT in men and women. Results: CIMT increased with age in both men and women. Women had lower values of CIMT than men (0.54&nbsp;mm vs 0.60&nbsp;mm, P=0.011). The analysis in three age subgroups revealed that CIMT values were comparable in men and women in group 1 (0.48&nbsp;mm vs 0.48&nbsp;mm, P=0.861), but over the age of 45&nbsp;years, CIMT values became significantly lower in women compared to men (group 2: 0.51&nbsp;mm vs 0.63&nbsp;mm, P=0.005; group 3: 0.63&nbsp;mm vs 0.72&nbsp;mm, P=0.020). Significant differences were observed between the sexes in terms of risk factor impact on CIMT. In men, only three factors significantly affected CIMT: age (b=+0.009, P&lt;0.0001), hypertension (b=+0.067, P&lt;0.05), and type 2 diabetes (b=+0.073, P&lt;0.05). In women, apart from age (b=+0.008, P&lt;0.0001) and type 2 diabetes (b=+0.111, P&lt;0.01), significant factors were pulse pressure (PP; b=+0.005, P&lt;0.0001), body mass index (b=+0.007, P&lt;0.05), increased waist circumference (b=+0.092, P&lt;0.01), and metabolic syndrome (b=+0.071, P&lt;0.05). In the multiple regression analysis, independent CIMT determinants for the entire group were age (&beta;=0.497, P&lt;0.001) and body mass index (&beta;=0.195, P=0.006). For males, age was the only independent determinant of CIMT (&beta;=0.669, P&lt;0.001). For females, these were PP (&beta;=0.317, P=0.014), age (&beta;=0.242, P=0.03), and increased waist circumference (&beta;=0.207, P=0.048). Conclusion: CIMT values are lower in women than in men, which is most pronounced over the age of 45&nbsp;years. There are sex-related differences in the profile of CV risk factors affecting CIMT: in males, CIMT is mostly determined by age, while in females, by age, PP, and increased waist circumference. Keywords: carotid intima media thickness, risk factors, sex difference

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

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    Introduction: 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. Methods: 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. Results: 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. Conclusion: 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

    Stroke prevention in patients from Latin American countries with non-valvular atrial fibrillation: Insights from the GARFIELD-AF registry

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    Background: Atrial fibrillation (AF) is an important preventable cause of stroke. Anticoagulation (AC) therapy can reduce this risk. However, prescribing patterns and outcomes in patients with non-valvular AF (NVAF) from Latin American countries are poorly described. Methods: Using data from the Global Anticoagulant Registry in the FIELD-AF (GARFIELD-AF), we examined the stroke prevention strategies and the 1-year outcomes in patients from four Latin American countries: Argentina, Brazil, Chile, and Mexico. Results: A total of 4162 patients (2010-2014) were included in this analysis. At the time of AF diagnosis, 39.9% of patients were prescribed vitamin K antagonists (VKA) ± antiplatelet (AP) therapy, 21.8% non-VKA oral anticoagulant (NOAC) ± AP, 24.1% AP only and 14.1% no antithrombotic treatment. The proportion of moderate-high risk patients receiving no AC therapy at participating centers was highest in Mexico (46.4%) and lowest in Chile (14.3%). During 1-year follow-up, the rates of all-cause mortality, stroke/SE and major bleeding were: 5.77 (95% CI) (5.06-6.56), 1.58 (1.23-2.02), and 0.99 (0.72-1.36) and per 100 person-years, respectively, which are higher than the global rates across all countries in GARFIELD-AF. Unadjusted rates of all-cause mortality were highest in Argentina, 6.95 (5.43-8.90), and lowest in Chile, 4.01 (2.92-5.52). Conclusions: GARFIELD-AF results describes the marked variation in the baseline characteristics and patterns of antithrombotic treatments in patients with NVAF in four Latin American countries. Over one-third of patients with a moderate-to-high risk of stroke received no AC therapy, highlighting the need for improved management of patients according to national guideline. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

    Quality of vitamin k antagonist control and 1-year outcomes in patients with atrial fibrillation: A global perspective from the GARFIELD-AF registry

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    Aims Vitamin K antagonists (VKAs) need to be individually dosed. International guidelines recommend a target range of international normalised ratio (INR) of 2.0-3.0 for stroke prevention in atrial fibrillation (AF). We analysed the time in this therapeutic range (TTR) of VKAtreated patients with newly diagnosed AF in the ongoing, global, observational registry GARFIELD-AF. Taking TTR as a measure of the quality of patient management, we analysed its relationship with 1-year outcomes, including stroke/systemic embolism (SE), major bleeding, and all-cause mortality. Methods and Results TTR was calculated for 9934 patients using 136,082 INR measurements during 1-year follow-up. The mean TTR was 55.0%; values were similar for different VKAs. 5851 (58.9%) patients had TTR&lt;65%; 4083 (41.1%) TTR≥65%. The proportion of patients with TTR≥65% varied from 16.7% in Asia to 49.4% in Europe. There was a 2.6-fold increase in the risk of stroke/SE, 1.5-fold increase in the risk of major bleeding, and 2.4-fold increase in the risk of all-cause mortality with TTR&lt;65% versus ≥65% after adjusting for potential confounders. The population attributable fraction, i.e. the proportion of events attributable to suboptimal anticoagulation among VKA users, was 47.7% for stroke/SE, 16.7% for major bleeding, and 45.4% for all-cause mortality. In patients with TTR&lt;65%, the risk of first stroke/SE was highest in the first 4 months and decreased thereafter (test for trend, p = 0.021). In these patients, the risk of first major bleed declined during follow-up (p = 0.005), whereas in patients with TTR≥65%, the risk increased over time (p = 0.027). Conclusion A large proportion of patients with AF had poor VKA control and these patients had higher risks of stroke/SE, major bleeding, and all-cause mortality. Our data suggest that there is room for improvement of VKA control in routine clinical practice and that this could substantially reduce adverse outcomes
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