RESUMEN

FUNDAMENTOS: A prevenção de acidente vascular encefálico é uma das prioridades no tratamento da fibrilação atrial (FA). Devido ao alto custo dos anticoagulantes diretos, os antagonistas da vitamina K (AVK) representam importante estratégia terapêutica oferecida pelo SUS aos pacientes com FA no Brasil. Entretanto, os preditores de desfechos clínicos relevantes foram pouco estudados no mundo real. O objetivo do estudo foi identificar a incidência e os preditores independentes de morte cardiovascular, eventos tromboembólicos, sangramento maior e não-maior clinicamente relevante, em pacientes com FA tratados com AVK. MÉTODOS: Coorte prospectiva de pacientes com FA recebendo ≥1 ano de varfarina ou femprocumona, incluídos em 2017/2018 e seguidos até 2019. Foram classificados como FA valvar ou não valvar de acordo com as diretrizes vigentes à época. Os desfechos clínicos foram morte cardiovascular, eventos tromboembólicos, sangramento maior e não maior clinicamente relevante, separadamente e como desfecho composto, e adjudicados de forma independente. Foram coletados o tempo na faixa terapêutica (TFT), os escores CHADS2, CHA2DS2-VASc, HAS-BLED e SAMe-TT2R2. RESULTADOS: Foram incluídos 1.350 pacientes, com idade média de 69,2 (±11,8) anos e 53,6% do sexo feminino, e seguimento de 17 (15-19) meses. A mediana do TFT foi 65%. Prevalência de comorbidades foi elevada e 38,4% apresentavam doença reumática. Incidência anual de eventos tromboembólicos e morte cardiovascular foi 4,4% e preditores foram tromboembolismo prévio (HR 2,12 [IC95% 1,22-3,67], TFT <50% (HR 1,98 [IC95% 1,16-3,37]) e taxa de filtração glomerular (TFG) <45mL/min/1,73m2 (HR 2,76 [IC95% 4,82-1,58]). Sangramento maior e não-maior clinicamente relevante foram 3,24%/ano (IC95% 2,47-4,14), e preditores foram sangramento prévio (HR 2,60 [IC95% 1,47- 4,61]) e prótese valvar mecânica (HR 1,91 [IC95% 1,15-3,15]). A incidência do desfecho composto por eventos tromboembólicos e hemorrágicos foi 8,7%/ano e preditores foram sangramento prévio (HR 1,70 [IC95% 1,07-2,70]), TFT <41% (HR 1,79 [IC95% 1,11-2,86]) e átrio esquerdo >44mm (HR 1,97 [IC95% 3,26-1,19]). A incidência anual de eventos aumentou gradualmente de acordo com pontuações mais altas dos escores de risco CHADS2, CHA2DS2-VASc e HAS-BLED. Os valores de TFT foram significativamente menores entre os pacientes com ≥3 pontos no escore SAMe-TT2R2. CONCLUSÕES: Tromboembolismo ou sangramento prévios, TFG e TFT reduzidos, prótese valvar mecânica, e átrio esquerdo aumentado foram preditores de desfechos clínicos em pacientes com FA tratados com AVK.

Asunto(s)

RESUMEN

BACKGROUND: Atrial fibrillation (AF) is a major risk factor for stroke. To enable improvements to AF diagnosis and follow-up care, understanding current patient pathways and barriers to optimal care are essential. We investigated the patient care pathways and their drivers, and the impact of the COVID-19 pandemic on patient pathways in a middle-income country setting, Brazil. METHODS: This mixed-methods study in São Paulo, included adults (≥18y) with AF from 13 primary/secondary healthcare facilities. Surveys using baseline, follow-up (administered ≥two months after baseline) and COVID-19 questionnaires (quantitative), and three focus group discussions (FGDs) were conducted. Minimum sample size for the quantitative component was 236 and we aimed to reach saturation with at least three FGDs for the qualitative component. Descriptive statistics were used for quantitative data and a content analysis was used for qualitative data to identify themes related to AF diagnosis and follow-up care. RESULTS: 267 participants completed the baseline questionnaire: 25% were diagnosed in primary care, 65% in an emergency or inpatient department. At follow-up (n = 259), 31% visited more than one facility for AF care, and 7% had no follow-up. Intervals between international normalised ratio (INR) tests were increased during the pandemic, and the number of healthcare visits and availability of medication were reduced. Seventeen patients participated in three FGDs and revealed that AF diagnosis often occurred following a medical emergency and patients often delay care-seeking due to misconceptions about AF symptoms. Long waiting times, doctor/patient interactions and health system factors, such as doctor availability and the referral system, influence where participants visited for follow-up care. CONCLUSIONS: Lack of public awareness and underdeveloped primary healthcare lead to delayed diagnosis, which impacts clinical outcomes and excess patient and healthcare system costs. Health system, care-provider, and pandemic factors disrupt timely and effective continuity of care.

Asunto(s)

Asunto(s)

RESUMEN

BACKGROUND: Atrial fibrillation (AF) negatively impacts health systems worldwide. We aimed to capture perceptions of and barriers and facilitators for AF care in Brazilian primary care units (PCUs) from the perspective of healthcare professionals (HCPs). METHODS: This mixed-methods, cross-sectional study utilised an exploratory sequential design, beginning with the quantitative data collection (up to 18 closed questions) immediately followed by a semi-structured interview. HCPs were recruited from 11 PCUs in the Sao Paulo region and included managers, physicians, pharmacists, nurses and community health agents. Descriptive statistics were used to present findings from the quantitative questionnaire and inductive analysis was used to identify themes from the qualitative data. RESULTS: One hundred seven HCPs were interviewed between September 2019 and May 2020. Three main themes were identified that encapsulated barriers and facilitators to AF care: access to care (appointments, equipment/tests and medication), HCP and patient roles (HCP/patient relationship and patient adherence) and the role of the organisation/system (infrastructure, training and protocols/guidelines). Findings from the qualitative analysis reinforced the quantitative findings, including a lack of AF-specific training for HCPs, protocols/guidelines on AF management, INR tests in the PCUs, patient knowledge of AF management and novel oral anticoagulants (NOACs) as key barriers to optimal AF care. CONCLUSIONS: Development and implementation of AF-specific training for PCU HCPs are needed in Brazil, along with evidence-based protocols and guidelines, educational programmes for patients, better access to INR tests for patients taking warfarin and availability of NOACs.

Asunto(s)

RESUMEN

Resumo Fundamento A associação entre o status de saúde cardiovascular ideal ( ideal cardiovascular health ( ICVH) e diagnóstico de fibrilação ou flutter atrial (FFA) foi menos estudado em comparação a outras doenças cardiovasculares. Objetivos Analisar a associação entre o diagnóstico de FFA e métricas e escores de ICVH no Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil). Métodos Este estudo analisou dados de 13141 participantes com dados completos. Os traçados eletrocardiográficos foram codificados de acordo com o Sistema de Minnesota, em um centro de leitura centralizado. As métricas do ICVH (dieta, atividade física, índice de massa corporal, tabagismo, glicemia de jeju, e colesterol total) e escores do ICVH foram calculados conforme proposto pela American Heart Association . Modelos de regressão logística bruta e ajustada foram construídos para analisar associações de métricas e escores do ICVH com diagnóstico de FFA. O nível de significância foi estabelecido em 0,05. Resultados A idade mediana da amostra foi de 55 anos, e 54,4% eram mulheres. Nos modelos ajustados, os escores de ICVH não apresentaram associação significativa com diagnóstico de FFA prevalente [odds ratio (OR):0,96; intervalo de confiança de 95% (IC95%):0,80-1,16; p=0,70). Perfis de pressão arterial ideal (OR:0,33; IC95%:0,1-0,74; p=0,007) e colesterol total ideal (OR:1,88; IC95%:1,19-2,98; p=0,007) foram significativamente associados com o diagnóstico de FFA. Conclusões Não foram identificadas associações significativas entre escores de ICVH global e diagnóstico de FFA após ajuste multivariado em nossas análises, devido, ao menos em parte, às associações antagônicas da FFA com métricas de pressão arterial e de colesterol total do ICVH. Nossos resultados sugerem que estimar a prevenção da FFA por meio de escore de ICVH global pode não ser adequado, e as métricas do ICVH devem ser consideradas separadamente.

Abstract Background The association between ideal cardiovascular health (ICVH) status and atrial fibrillation or flutter (AFF) diagnosis has been less studied compared to other cardiovascular diseases. Objective To analyze the association between AFF diagnosis and ICVH metrics and scores in the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). Methods This study analyzed data from 13,141 participants with complete data. Electrocardiographic tracings were coded according to the Minnesota Coding System, in a centralized reading center. ICVH metrics (diet, physical activity, body mass index, smoking, blood pressure, fasting plasma glucose, and total cholesterol) and scores were calculated as proposed by the American Heart Association. Crude and adjusted binary logistic regression models were built to analyze the association of ICVH metrics and scores with AFF diagnosis. Significance level was set at 0.05. Results The sample had a median age of 55 years and 54.4% were women. In adjusted models, ICVH scores were not significantly associated with prevalent AFF diagnosis (odds ratio [OR]:0.96; 95% confidence interval [95% CI]:0.80-1.16; p=0.70). Ideal blood pressure (OR:0.33; 95% CI:0.15-0.74; p=0.007) and total cholesterol (OR:1.88; 95% CI:1.19-2.98; p=0.007) profiles were significantly associated with AFF diagnosis. Conclusions No significant associations were identified between global ICVH scores and AFF diagnosis after multivariable adjustment in our analyses, at least partially due to the antagonistic associations of AFF with blood pressure and total cholesterol ICVH metrics. Our results suggest that estimating the prevention of AFF burden using global ICVH scores may not be adequate, and ICVH metrics should be considered in separate.

RESUMEN

BACKGROUND: The association between ideal cardiovascular health (ICVH) status and atrial fibrillation or flutter (AFF) diagnosis has been less studied compared to other cardiovascular diseases. OBJECTIVE: To analyze the association between AFF diagnosis and ICVH metrics and scores in the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). METHODS: This study analyzed data from 13,141 participants with complete data. Electrocardiographic tracings were coded according to the Minnesota Coding System, in a centralized reading center. ICVH metrics (diet, physical activity, body mass index, smoking, blood pressure, fasting plasma glucose, and total cholesterol) and scores were calculated as proposed by the American Heart Association. Crude and adjusted binary logistic regression models were built to analyze the association of ICVH metrics and scores with AFF diagnosis. Significance level was set at 0.05. RESULTS: The sample had a median age of 55 years and 54.4% were women. In adjusted models, ICVH scores were not significantly associated with prevalent AFF diagnosis (odds ratio [OR]:0.96; 95% confidence interval [95% CI]:0.80-1.16; p=0.70). Ideal blood pressure (OR:0.33; 95% CI:0.15-0.74; p=0.007) and total cholesterol (OR:1.88; 95% CI:1.19-2.98; p=0.007) profiles were significantly associated with AFF diagnosis. CONCLUSIONS: No significant associations were identified between global ICVH scores and AFF diagnosis after multivariable adjustment in our analyses, at least partially due to the antagonistic associations of AFF with blood pressure and total cholesterol ICVH metrics. Our results suggest that estimating the prevention of AFF burden using global ICVH scores may not be adequate, and ICVH metrics should be considered in separate.

FUNDAMENTO: A associação entre o status de saúde cardiovascular ideal ( ideal cardiovascular health ( ICVH) e diagnóstico de fibrilação ou flutter atrial (FFA) foi menos estudado em comparação a outras doenças cardiovasculares. OBJETIVOS: Analisar a associação entre o diagnóstico de FFA e métricas e escores de ICVH no Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil). MÉTODOS: Este estudo analisou dados de 13141 participantes com dados completos. Os traçados eletrocardiográficos foram codificados de acordo com o Sistema de Minnesota, em um centro de leitura centralizado. As métricas do ICVH (dieta, atividade física, índice de massa corporal, tabagismo, glicemia de jeju, e colesterol total) e escores do ICVH foram calculados conforme proposto pela American Heart Association . Modelos de regressão logística bruta e ajustada foram construídos para analisar associações de métricas e escores do ICVH com diagnóstico de FFA. O nível de significância foi estabelecido em 0,05. RESULTADOS: A idade mediana da amostra foi de 55 anos, e 54,4% eram mulheres. Nos modelos ajustados, os escores de ICVH não apresentaram associação significativa com diagnóstico de FFA prevalente [odds ratio (OR):0,96; intervalo de confiança de 95% (IC95%):0,80-1,16; p=0,70). Perfis de pressão arterial ideal (OR:0,33; IC95%:0,1-0,74; p=0,007) e colesterol total ideal (OR:1,88; IC95%:1,19-2,98; p=0,007) foram significativamente associados com o diagnóstico de FFA. CONCLUSÕES: Não foram identificadas associações significativas entre escores de ICVH global e diagnóstico de FFA após ajuste multivariado em nossas análises, devido, ao menos em parte, às associações antagônicas da FFA com métricas de pressão arterial e de colesterol total do ICVH. Nossos resultados sugerem que estimar a prevenção da FFA por meio de escore de ICVH global pode não ser adequado, e as métricas do ICVH devem ser consideradas separadamente.

RESUMEN

BACKGROUND: Atrial fibrillation or flutter (AFF) is the most common sustained cardiac arrhythmia. Limited data can be found on AFF epidemiology in South America. OBJECTIVE: The present study sought to describe the clinical epidemiology of AFF and the use of stroke prevention medication in the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) baseline assessment. METHODS: This study analyzed data from 13,260 ELSA-Brasil participants. AFF was defined according to ECG recording or by self-report. Logistic regression models were built to analyze factors associated with AFF. This study also analyzed if age and sex were associated with anticoagulant use for stroke prevention. Significance level was set at 5%. RESULTS: Median age was 51 years and 7,213 (54.4%) participants were women. AFF was present in 333 (2.5%) participants. Increasing age (odds ratio [OR]:1.05; 95% confidence interval [95%CI]: 1.04-1.07), hypertension (OR:1.44; 95%CI: 1.14-1.81), coronary heart disease (OR: 5.11; 95%CI: 3.85-6.79), heart failure (OR:7.37; 95%CI: 5.00-10.87), and rheumatic fever (OR:3.38; 95%CI: 2.28-5.02) were associated with AFF. From 185 participants with AFF and a CHA2DS2-VASc score ≥2, only 20 (10.8%) used anticoagulants (50.0% among those with AFF in the baseline ECG). Stroke prevention in this group was associated with a higher age (1.8% vs 17.7% in those aged ≤ 54 and ≥ 65 years, respectively; p=0.013). A trend towards a reduced anticoagulant use was observed in women (7.1% vs. 16.4% in women and men, respectively; p=0.055). CONCLUSIONS: At the ELSA-Brasil baseline, 2.5% of the participants had AFF. The lack of stroke prevention was common, which is an especially challenging point for healthcare in this setting.

FUNDAMENTO: A fibrilação ou flutter atrial (FFA) é a arritmia cardíaca sustentada mais comum. Existem poucos dados sobre a epidemiologia da FFA na América do Sul. OBJETIVO: O presente estudo procurou descrever a epidemiologia clínica da FFA e o uso de anticoagulantes na avaliação da linha de base do Estudo Longitudinal da Saúde do Adulto (ELSA-Brasil). MÉTODOS: Foram analisados dados de 13.260 participantes do ELSA-Brasil. A FFA foi definida pelo eletrocardiograma ou por autorrelato. Modelos de regressão logística foram construídos para analisar fatores associados à FFA. Este estudo também analisou se idade e sexo estavam associados ao uso de anticoagulantes para evitar acidente vascular cerebral. O nível de significância foi de 5%. RESULTADOS: A idade mediana foi de 51 anos, e 7.213 (54,4%) participantes eram mulheres. A FFA foi detectada em 333 (2,5%) participantes. O aumento da idade (razão de chances [RC]:1,05; intervalo de confiança de 95% [IC95%]: 1,04-1,07), hipertensão (RC:1,44; IC95%:1,14-1,81) coronariopatia (RC: 5,11; IC95%:3,85­6,79), insuficiência cardíaca (RC:7,37; IC95%:5,00­10,87) e febre reumática (RC:3,38; IC95%:2,28­5,02) foram associadas à FFA. Dos 185 participantes com FFA e pontuação no CHA2DS2-VASc≥2, apenas 20 (10,8%) usavam anticoagulantes (50,0% entre aqueles com FFA no eletrocardiograma de linha de base). O uso de anticoagulantes nesse grupo foi associado a maior idade (1,8% vs 17,7% naqueles com idade ≤ 54 e ≥ 65 anos, respectivamente; p=0,013). Observou-se uma tendência ao menor uso de anticoagulantes em mulheres (7,1% vs. 16,4% em mulheres e homens, respectivamente; p=0,055). CONCLUSÕES: No recrutamento do ELSA-Brasil, 2,5% dos participantes tinham FFA. O baixo uso de anticoagulantes era comum, o que representa um desafio para os cuidados de saúde nesse cenário.

Asunto(s)

RESUMEN

Resumo Fundamento: A fibrilação ou flutter atrial (FFA) é a arritmia cardíaca sustentada mais comum. Existem poucos dados sobre a epidemiologia da FFA na América do Sul. Objetivo: O presente estudo procurou descrever a epidemiologia clínica da FFA e o uso de anticoagulantes na avaliação da linha de base do Estudo Longitudinal da Saúde do Adulto (ELSA-Brasil). Métodos: Foram analisados dados de 13.260 participantes do ELSA-Brasil. A FFA foi definida pelo eletrocardiograma ou por autorrelato. Modelos de regressão logística foram construídos para analisar fatores associados à FFA. Este estudo também analisou se idade e sexo estavam associados ao uso de anticoagulantes para evitar acidente vascular cerebral. O nível de significância foi de 5%. Resultados: A idade mediana foi de 51 anos, e 7.213 (54,4%) participantes eram mulheres. A FFA foi detectada em 333 (2,5%) participantes. O aumento da idade (razão de chances [RC]:1,05; intervalo de confiança de 95% [IC95%]: 1,04-1,07), hipertensão (RC:1,44; IC95%:1,14-1,81) coronariopatia (RC: 5,11; IC95%:3,85-6,79), insuficiência cardíaca (RC:7,37; IC95%:5,00-10,87) e febre reumática (RC:3,38; IC95%:2,28-5,02) foram associadas à FFA. Dos 185 participantes com FFA e pontuação no CHA2DS2-VASc≥2, apenas 20 (10,8%) usavam anticoagulantes (50,0% entre aqueles com FFA no eletrocardiograma de linha de base). O uso de anticoagulantes nesse grupo foi associado a maior idade (1,8% vs 17,7% naqueles com idade ≤ 54 e ≥ 65 anos, respectivamente; p=0,013). Observou-se uma tendência ao menor uso de anticoagulantes em mulheres (7,1% vs. 16,4% em mulheres e homens, respectivamente; p=0,055). Conclusões: No recrutamento do ELSA-Brasil, 2,5% dos participantes tinham FFA. O baixo uso de anticoagulantes era comum, o que representa um desafio para os cuidados de saúde nesse cenário.

Abstract Background: Atrial fibrillation or flutter (AFF) is the most common sustained cardiac arrhythmia. Limited data can be found on AFF epidemiology in South America. Objective: The present study sought to describe the clinical epidemiology of AFF and the use of stroke prevention medication in the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) baseline assessment. Methods: This study analyzed data from 13,260 ELSA-Brasil participants. AFF was defined according to ECG recording or by self-report. Logistic regression models were built to analyze factors associated with AFF. This study also analyzed if age and sex were associated with anticoagulant use for stroke prevention. Significance level was set at 5%. Results: Median age was 51 years and 7,213 (54.4%) participants were women. AFF was present in 333 (2.5%) participants. Increasing age (odds ratio [OR]:1.05; 95% confidence interval [95%CI]: 1.04-1.07), hypertension (OR:1.44; 95%CI: 1.14-1.81), coronary heart disease (OR: 5.11; 95%CI: 3.85-6.79), heart failure (OR:7.37; 95%CI: 5.00-10.87), and rheumatic fever (OR:3.38; 95%CI: 2.28-5.02) were associated with AFF. From 185 participants with AFF and a CHA2DS2-VASc score ≥2, only 20 (10.8%) used anticoagulants (50.0% among those with AFF in the baseline ECG). Stroke prevention in this group was associated with a higher age (1.8% vs 17.7% in those aged ≤ 54 and ≥ 65 years, respectively; p=0.013). A trend towards a reduced anticoagulant use was observed in women (7.1% vs. 16.4% in women and men, respectively; p=0.055). Conclusions: At the ELSA-Brasil baseline, 2.5% of the participants had AFF. The lack of stroke prevention was common, which is an especially challenging point for healthcare in this setting.

Asunto(s)

RESUMEN

Preventing premature non-communicable disease mortality necessitates a thorough review of one of the most important risk factors for stroke, which is atrial fibrillation (AF). The latter and AF-related stroke are still considered to be problems of high-income countries and are frequently overlooked in low- and middle-income countries (LMICs). In this narrative review, we provide an overview of studies that evaluated at least one of the following determinants of AF burden in LMICs: current epidemiology and trends, stroke prevention, health outcomes, and economic burden. Studies focusing on samples close to the general population (including community- and primary care-based samples) indicate sex-specific prevalence rates up to 7.4% in LMICs. Although AF prevalence is still higher in high-income countries than LMICs, the gap in AF burden between these two groups has been reducing in the past three decades. Oral anticoagulant (OAC) therapy for stroke prevention is underused in LMICs, and there are little data on OAC therapy in relation to stroke risk scores, such as CHA2DS2-VASc. Available data also points to higher morbidity and mortality for patient with AF in LMICs than their counterparts in high-income countries. Data on the consequent economic burden in LMICs is scarce, but it is reasonable to consider it will follow the same trend as that observed for health outcomes. Raising the visibility of AF as a public health problem in LMICs is necessary as a first step to providing adequate care for patients with this condition.

RESUMEN

BACKGROUND: Real-world data from different regions are needed to support the external validity of controlled trials and assess the impact of new oral anticoagulants (NOAC) in clinical practice. METHODS: "GLORIA-AF" is a large, ongoing, multicenter, global, prospective registry program in patients with newly diagnosed non-valvular atrial fibrillation (NVAF) at risk of stroke. Newly diagnosed patients with NVAF (within 4.5 months) and a CHA2DS2-VASc score ≥ 1 were consecutively enrolled. The study objective was to estimate the incidence rate of stroke and major bleeding after a two year follow up of patients on dabigatran that participated in the "GLORIA-AF" study (Phase II) in Latin America. RESULTS: Latin America included 378 eligible patients that received dabigatran in eight countries (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Perú, and Venezuela): 56.3% were male; mean age was 70.3 ± 10.8 years; 43.4% had paroxysmal AF; 36.0% persistent AF and 20.6% permanent AF. Mean CHA2DS2-VASc score was 3.2 ± 1.4; mean HAS-BLED score was 1.2 ± 0.8. Incidence rates for clinical events after 2-years of follow-up per 100 patient-years were as follows: stroke 0.33 (95% CI: 0.04-1.17), major bleeding 0.49 (95% CI: 0.10-1.42) and all-cause death 4.06 (95% CI: 2.63-6.00). Persistence with dabigatran at 6, 12 and 24 months was 91%, 86%, and 80%, respectively. CONCLUSION: These regional data shows the sustained safety and effectiveness of dabigatran over two years of follow-up, consistent with already available evidence. An increase in accessibility and incorporation of NOAC to anticoagulant treatment strategies could potentially have a positive impact on AF stroke prevention in Latin America.

RESUMEN

AIMS: This study aimed to describe baseline characteristics of patients with atrial fibrillation (AF) at risk of stroke with and without history of heart failure (HF) and report 2-year outcomes in the dabigatran-treated subset of a prospective, global, observational study (GLORIA-AF). METHODS AND RESULTS: Newly diagnosed patients with AF and CHA2 DS2 -VASc score ≥ 1 were consecutively enrolled. Baseline characteristics were assessed by the presence or absence of HF diagnosis at enrolment. Incidence rates for outcomes in dabigatran-treated patients were estimated with and without standardization by stroke (excluding HF component) and bleeding risk scores. A total of 15 308 eligible patients were enrolled, including 15 154 with known HF status; of these, 3679 (24.0%) had been diagnosed with HF, 11 475 (75.0%) had not. Among 4873 dabigatran-treated patients, 1169 (24.0%) had HF, and 3658 (75.1%) did not; the risk of stroke was high (CHA2 DS2 -VASc score ≥ 2) for 94.3% of patients with HF and 85.8% without, while 6.0% and 7.0%, respectively, had a high bleeding risk (HAS-BLED ≥ 3). Incidence rates of all-cause death in dabigatran-treated patients with and without HF, standardized for CHA2 DS2 -VASc and HAS-BLED scores, were 4.76 vs. 1.80 per 100 patient years (py), with roughly comparable rates of stroke (0.82 vs. 0.60 per 100 py) and major bleeding (1.20 vs. 0.92 per 100 py). CONCLUSIONS: Patients with AF and history of HF may have greater disease burden at AF diagnosis and increased mortality rates vs. patients without HF. Stroke and major bleeding rates were roughly comparable between groups confirming the long-term safety and effectiveness of dabigatran in patients with HF.

Asunto(s)

RESUMEN

RESUMEN Introducción: El GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) es un registro internacional, prospectivo, en tres fases, para determinar la seguridad y eficacia del dabigatrán en pacientes con fibrilación auricular no valvular recientemente diagnosticada, en riesgo de stroke. La fase II empezó cuando el dabigatrán, el primer anticoagulante oral no antagonista de la vitamina K (NOAC) estuvo disponible. Objetivos: Describir los datos clínicos basales de la fase II en la población general y el seguimiento a 2 años de aquellos que recibieron dabigatrán. Material y Métodos: Se reclutaron un total de 15 644 pacientes, de los cuales 15 308 fueron elegibles y 4873 recibieron dabigatrán. Se analizaron las características de la fibrilación auricular, los hallazgos en el seguimiento y las enfermedades concomitantes. Los datos fueron analizados usando estadísticas descriptivas. Resultados: Del total de pacientes elegibles, el 45,5% eran mujeres, con una edad promedio de 71 (rango intercuartilo: 64-78) años. Los pacientes eran de Europa (47,9%), América del Norte (22,2%), Asia (20,1%), América Latina (6,0%) y Medio Oriente/ África (3,9%). La mayoría se encontraba en alto riesgo de stroke (CHA2DS2-VASc score >2; 86,1%); un 13,9% tuvieron riesgo moderado (CHA2DS2-VASc score >1). El 80,3% recibieron anticoagulantes orales; de ellos, el 47,9% recibieron NOAC y el 32,4%, antagonistas de la vitamina K (VKA); 12,0% recibieron agentes antiagregantes plaquetarios y el 7,6% no recibieron tratamiento antitrombótico. A 2 años de seguimiento, el 70,5% permanecieron en dabigatrán. Conclusiones: Los datos de la fase II del registro GLORIA-AF demostraron que, en FA no valvular, los NOAC han sido ampliamente adoptados en la práctica clínica y fueron más frecuentemente prescriptos que los VKA. No obstante, una gran proporción de pacientes en todo el mundo permanecieron sin tratamiento.

ABSTRACT Background: GLORIA-AF is a prospective, global, 3-phase registry program to determine the safety and effectiveness of dabigatran in patients with newly diagnosed non-valvular atrial fibrillation at risk of stroke. Phase II began when dabigatran, the first non-vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives: To describe phase II baseline clinical data in the general population and 2-year follow-up of those patients treated with dabigatran. Methods: A total of 15,644 patients were enrolled, 15,308 of whom were eligible and 4,873 received dabigatran. Atrial fibrillation disease characteristics, follow-up findings and concomitant diseases were collected. Data were analyzed using descriptive statistics. Results: Of the total eligible patients, 45.5% were female; median age was 71.0 (interquartile range: 64, 78) years. Patients were from Europe (47.9%), North America (22.2%), Asia (20.1%), Latin America (6.0%), and the Middle East/Africa (3.9%). Most had high stroke risk (CHA2DS2-VASc score ≥2; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc =1). Overall, 80.3% received oral anticoagulants, of whom 47.9% received NOACs and 32.4% vitamin K antagonists (VKA); 12.0% received anti-platelet agents; and 7.6% received no antithrombotic treatment. At 2-year follow-up, 70.5% remained on dabigatran. Conclusions: Data from GLORIA-AF phase II showed that in non-valvular AF, NOACs have been highly adopted in clinical practice, becoming more frequently prescribed than VKAs. Worldwide, however, a large proportion of patients remain undertreated.

RESUMEN

BACKGROUND AND OBJECTIVE: In patients with atrial fibrillation following percutaneous coronary intervention, if a proton pump inhibitor is used, could that allow the use of warfarin triple therapy, or is there additional reduction in bleeding while using it with dual therapy? METHODS: The RE-DUAL PCI trial randomized 2725 patients with atrial fibrillation post-percutaneous coronary intervention to dabigatran dual therapy (110 or 150 mg twice daily, with clopidogrel or ticagrelor) or warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin for 1-3 months). This prespecified subgroup analysis evaluated risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization according to baseline use of a proton pump inhibitor. RESULTS: Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline. Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05). For gastrointestinal bleeding, no interaction was observed between study treatment and proton pump inhibitor use (interaction p values 0.84 and 0.62 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin triple therapy). CONCLUSIONS: Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy, regardless of proton pump inhibitor use at baseline, in patients with atrial fibrillation who underwent percutaneous coronary intervention. Risk of the composite efficacy endpoint appeared to be similar for dabigatran dual therapy vs warfarin triple therapy in patients receiving/not receiving a proton pump inhibitor. CLINICALTRIALS. GOV UNIQUE IDENTIFIER: NCT02164864.

Asunto(s)

RESUMEN

The field of observational studies or "real world studies" is in rapid development with many new techniques introduced and increased understanding of traditional methods. For this reason, the current paper provides an overview of current methods with focus on new techniques. Some highlights can be emphasized: We provide an overview of sources of data for observational studies. There is an overview of sources of bias and confounding. Next There is an overview of causal inference techniques that are increasingly used. The most commonly used techniques for statistical modelling are reviewed with focus on the important distinction of risk versus prediction. The final section provides examples of common problems with reporting observational data.

Asunto(s)

RESUMEN

AIMS: Left atrium (LA) dilation is associated with adverse cardiovascular (CV) outcomes. Blood stasis, thrombus formation and atrial fibrillation may occur, especially in heart failure (HF) patients. It is not known whether preventive antithrombotic treatment may decrease the incidence of CV events in HF patients with LA enlargement. We investigated the relationship between LA enlargement and CV outcomes in HF patients and the effect of different antithrombotic treatments. METHODS AND RESULTS: Two-dimensional echocardiography with LA volume index (LAVi) measurement was performed in 1148 patients with systolic HF from the Warfarin versus Aspirin in Reduced Ejection Fraction (WARCEF) trial. Patients were randomized to warfarin or aspirin and followed for 3.4 ± 1.7 years. While the primary aim of the trial was a composite of ischaemic stroke, death, and intracerebral haemorrhage, the present report focuses on the individual CV events, whose incidence was compared across different LAVi and treatment subgroups. After adjustment for demographics and clinical covariates, moderate or severe LA enlargement was significantly associated with total death (hazard ratio 1.6 and 2.7, respectively), CV death (HR 1.7 and 3.3), and HF hospitalization (HR 2.3 and 2.6) but not myocardial infarction (HR 1.0 and 1.4) or ischaemic stroke (1.1 and 1.5). The increased risk was observed in both patients treated with warfarin or aspirin. In warfarin-treated patients, a time in therapeutic range >60% was associated with lower event rates, and an interaction between LAVi and time in therapeutic range was observed for death (P = 0.034). CONCLUSIONS: In patients with systolic HF, moderate or severe LA enlargement is associated with death and HF hospitalization despite treatment with antithrombotic medications. The possibility that achieving a more consistent therapeutic level of anticoagulation may decrease the risk of death requires further investigation.

Asunto(s)

RESUMEN

The study aimed to establish a relationship of ethnicity to diastolic dysfunction in subjects of African-Caribbean and South Asian origins and the impact of diastolic dysfunction and ethnicity on all-cause and cardiovascular mortality. Hypertensive subjects with ejection fraction ≥55% and no history of ischaemic heart disease/valve pathology (n = 1546, 830 South Asians and 716 African-Caribbeans) were identified from the Ethnic-Echocardiographic Heart of England Screening Study (E-ECHOES). Diastolic function and cardiac remodelling were measured by echocardiography. African-Caribbean ethnicity was associated with lower prevalence of having diastolic dysfunction (odds ratio 0.67, 95% confidence interval 0.51-0.87, p = 0.003) and increased left ventricular filling pressure (odds ratio 0.48, 95% confidence interval 0.34-0.69, p < 0.001) as well as lower left atrial index (p < 0.001). This was the case despite the fact that African-Caribbean ethnicity was independently associated with higher left ventricular mass index (p < 0.001). Ninety-two deaths (6%) occurred during 68 ± 21 months follow-up. On Cox regression analysis, South Asian ethnicity (p = 0.024) was predictive of all-cause death before adjustment for parameters of diastolic dysfunction, but it was no longer predictive of death after accounting for these variables. South Asian ethnicity is independently associated with worse parameters of diastolic function in hypertension, despite African-Caribbeans having more prominent hypertrophy.

Asunto(s)

RESUMEN

Abstract Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, with an estimated prevalence of 1-2% in North America and Europe. The increased prevalence of AF in Latin America is associated with an ageing general population, along with poor control of key risk factors, including hypertension. As a result, stroke prevalence and associated mortality have increased dramatically in the region. Therefore, the need for effective anticoagulation strategies in Latin America is clear. The aim of this review is to provide a contemporary overview of anticoagulants for stroke prevention. The use of vitamin K antagonists (VKAs, eg, warfarin) and aspirin in the prevention of stroke in patients with AF in Latin America remains common, although around one fifth of all AF patients receive no anticoagulation. Warfarin use is complicated by a lack of access to effective monitoring services coupled with an unpredictable pharmacokinetic profile. The overuse of aspirin is associated with significant bleeding risks and reduced efficacy for stroke prevention in this patient group. The non-VKA oral anticoagulants (NOACbs) represent a potential means of overcoming many limitations associated with VKA and aspirin use, including a reduction in the need for monitoring and a reduced risk of hemorrhagic events. The ultimate decision of which anticoagulant drug to utilize in AF patients depends on a multitude of factors. More research is needed to appreciate the impact of these factors in the Latin American population and thereby reduce the burden of AF-associated stroke in this region.

Resumo A fibrilação atrial (FA) é a arritmia cardíaca sustentada mais comum, com uma prevalência estimada de 1-2% na América do Norte e Europa. O aumento da prevalência da FA na América Latina está associado com o envelhecimento da população geral, juntamente com um mal controle dos principais fatores de risco, incluindo a hipertensão arterial. Como resultado, a prevalência do acidente vascular cerebral (AVC) e a mortalidade associada a ele aumentou dramaticamente na região. Há, portanto, uma clara necessidade de estratégias efetivas de anticoagulação na América Latina. O objetivo desta revisão é oferecer uma visão atual da anticoagulação na prevenção do AVC. O uso de antagonistas da vitamina K (AVKs, ex.: varfarina) e ácido acetilsalicílico (AAS) na prevenção do AVC em pacientes com FA na América Latina permanece frequente, apesar de cerca de um quinto de todos os pacientes com FA não receberem anticoagulação. O uso da varfarina é complicado pela falta de acesso a serviços de monitoramento eficazes, juntamente com um perfil farmacocinético imprevisível. A utilização excessiva do AAS está associada com riscos significativos de sangramento e eficácia reduzida na prevenção do AVC neste grupo de pacientes. Os novos anticoagulantes orais não AVK (NOACs) representam um meio potencial de superar muitas limitações associadas ao uso dos AVKs e do AAS, incluindo uma redução na necessidade de monitoramento e risco reduzido de eventos hemorrágicos. A decisão final sobre qual anticoagulante utilizar em pacientes com FA depende de diversos fatores. Pesquisas adicionais são necessárias para avaliar o impacto desses fatores na população latino-americana e, assim, reduzir o ônus do AVC associado à FA nesta região.

Asunto(s)

RESUMEN

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, with an estimated prevalence of 1-2% in North America and Europe. The increased prevalence of AF in Latin America is associated with an ageing general population, along with poor control of key risk factors, including hypertension. As a result, stroke prevalence and associated mortality have increased dramatically in the region. Therefore, the need for effective anticoagulation strategies in Latin America is clear. The aim of this review is to provide a contemporary overview of anticoagulants for stroke prevention. The use of vitamin K antagonists (VKAs, eg, warfarin) and aspirin in the prevention of stroke in patients with AF in Latin America remains common, although around one fifth of all AF patients receive no anticoagulation. Warfarin use is complicated by a lack of access to effective monitoring services coupled with an unpredictable pharmacokinetic profile. The overuse of aspirin is associated with significant bleeding risks and reduced efficacy for stroke prevention in this patient group. The non-VKA oral anticoagulants (NOACbs) represent a potential means of overcoming many limitations associated with VKA and aspirin use, including a reduction in the need for monitoring and a reduced risk of hemorrhagic events. The ultimate decision of which anticoagulant drug to utilize in AF patients depends on a multitude of factors. More research is needed to appreciate the impact of these factors in the Latin American population and thereby reduce the burden of AF-associated stroke in this region.

Asunto(s)

RESUMEN

Los NOAC (No antivitamina K AntiCoagulantes) representan una opción atractiva para numerosos pacientes con fibrilación auricular (FA). Los diversos NOAC tienen propiedades levemente diferentes, por lo que su prescripción debe realizarse en base a las características del paciente. Frente a la necesidad de elegir entre varios NOAC, este artículo ofrece un enfoque centrado en el paciente para seleccionar el mejor NOAC en aquellos con FA no valvular.

A non-Vitamin K antagonist oral anticoagulant (NOAC) is an attractive option for many patients with atrial fibrillation (AF). The various NOACs have slightly different properties, and thus prescribing NOACs should be based on patient characteristics. With several NOACs to choose from, this article offers a patient-centred approach in choosing the best choice of NOACs for non-valvular AF patients.

RESUMEN

BACKGROUND: Intracranial hemorrhage is the most feared complication of oral anticoagulant treatment. The optimal treatment option for patients with atrial fibrillation who survive an intracranial hemorrhage remains unknown. We hypothesized that restarting oral anticoagulant treatment was associated with a lower risk of stroke and mortality in comparison with not restarting. METHODS AND RESULTS: Linkage of 3 Danish nationwide registries in the period between 1997 and 2013 identified patients with atrial fibrillation on oral anticoagulant treatment with incident intracranial hemorrhage. Patients were stratified by treatment regimens (no treatment, oral anticoagulant treatment, or antiplatelet therapy) after the intracranial hemorrhage. Event rates were assessed 6 weeks after hospital discharge and compared with Cox proportional hazard models. In 1752 patients (1 year of follow-up), the rate of ischemic stroke/systemic embolism and all-cause mortality (per 100 person-years) for patients treated with oral anticoagulants was 13.6, in comparison with 27.3 for nontreated patients and 25.7 for patients receiving antiplatelet therapy. The rate of ischemic stroke/systemic embolism and all-cause mortality (per 100 person-years) for recurrent intracranial hemorrhage, the rate of ischemic stroke/systemic embolism, and all-cause mortality (per 100 person-years) patients treated with oral anticoagulants was 8.0, in comparison with 8.6 for nontreated patients and 5.3 for patients receiving antiplatelet therapy. The adjusted hazard ratio of ischemic stroke/systemic embolism and all-cause mortality was 0.55 (95% confidence interval, 0.39-0.78) in patients on oral anticoagulant treatment in comparison with no treatment. For ischemic stroke/systemic embolism and for all-cause mortality, hazard ratios were 0.59 (95% confidence interval, 0.33-1.03) and 0.55 (95% confidence interval, 0.37-0.82), respectively. CONCLUSIONS: Oral anticoagulant treatment was associated with a significant reduction in ischemic stroke/all-cause mortality rates, supporting oral anticoagulant treatment reintroduction after intracranial hemorrhage as feasible. Future trials are encouraged to guide clinical practice in these patients.

Asunto(s)