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Stroke Prevention in Patients from Latin American Countries with Non-Valvular Atrial Fibrillation: Insights from the GARFIELD-AF Registry

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Stroke Prevention in Patients from Latin American Countries with Non-Valvular Atrial Fibrillation: Insights from the GARFIELD-AF Registry Received: 10 December 2018 Revised: 1 March 2019 Accepted: 14 March 2019 DOI: 10.1002/clc.23176 CLINICAL INVESTIGATIONS Stroke prevention in patients from Latin American countries with non-valvular atrial fibrillation: Insights from the GARFIELD-AF registry Carlos Jerjes-Sanchez1 | Ramon Corbalan2 | Antonio C. P. Barretto3 | Hector L. Luciardi4 | Jagan Allu5 | Laura Illingworth5 | Karen S. Pieper5,6 | Gloria Kayani5 | for the GARFIELD-AF Investigators† 1Instituto de Cardiologia y Medicina Vascular, TEC Salud, Tecnológico de Monterrey, Background: Atrial fibrillation (AF) is an important preventable cause of stroke. Anticoagulation Monterrey, Mexico (AC) therapy can reduce this risk. However, prescribing patterns and outcomes in patients with 2Cardiovascular Division, Pontificia non-valvular AF (NVAF) from Latin American countries are poorly described. Universidad Catolica, Santiago, Chile Methods: Using data from the Global Anticoagulant Registry in the FIELD-AF (GARFIELD-AF), 3 Hospital das Clínicas da Faculdad de Medicina we examined the stroke prevention strategies and the 1-year outcomes in patients from four da USP, Sao Paulo, Brazil Latin American countries: Argentina, Brazil, Chile, and Mexico. 4Universidad Nacional de Tucumán, San Miguel de Tucuman, Argentina Results: A total of 4162 patients (2010-2014) were included in this analysis. At the time of AF 5Thrombosis Research Institute, London, UK diagnosis, 39.9% of patients were prescribed vitamin K antagonists (VKA) ± antiplatelet 6Duke Clinical Research Institute, Durham, (AP) therapy, 21.8% non-VKA oral anticoagulant (NOAC) ± AP, 24.1% AP only and 14.1% no North Carolina antithrombotic treatment. The proportion of moderate-high risk patients receiving no AC ther- Correspondence apy at participating centers was highest in Mexico (46.4%) and lowest in Chile (14.3%). During Carlos Jerjes-Sanchez. Investigación Clínica 1-year follow-up, the rates of all-cause mortality, stroke/SE and major bleeding were: 5.77 (95% Instituto de Cardiología y Medicina Vascular, CI) (5.06-6.56), 1.58 (1.23-2.02), and 0.99 (0.72-1.36) and per 100 person-years, respectively, TEC Salud y Centro de Investigación Traslacional Escuela de Medicina Tecnologico which are higher than the global rates across all countries in GARFIELD-AF. Unadjusted rates of de Monterrey, Monterrey, Mexico. all-cause mortality were highest in Argentina, 6.95 (5.43-8.90), and lowest in Chile, 4.01 Email: [email protected]; carlos. (2.92-5.52). [email protected] Conclusions: GARFIELD-AF results describes the marked variation in the baseline characteris- Funding information Bayer AG; Bayer tics 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. KEYWORDS antithrombotic treatment, atrial fibrillation, Latin American, outcomes 1 | INTRODUCTION Atrial fibrillation (AF) is the most common cardiac arrhythmia encoun- †A complete list of the investigators are given in the Appendix. tered in clinical practice, with non-valvular AF (NVAF) comprising the This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc. Clinical Cardiology. 2019;42:553–560. wileyonlinelibrary.com/journal/clc 553 554 JERJES-SANCHEZ, ET AL. majority of cases.1 The prevalence of AF is increasing in both devel- cardiovascular risk factors, care setting speciality and location, anti- oped and developing countries, owing to an aging population, and this thrombotic therapy regimen in treated patients, and the main reasons increase is predicted to continue over the coming decades.2 for not providing anticoagulant treatment in untreated patients. Inter- Patients with AF have a 5-fold greater risk of stroke and fre- national normalized ratio values (INRs) were collected during the first quently present in elderly patients. Common risk factors for stroke are year of follow-up. Stroke risk was assessed according to CHA2DS2- hypertension, diabetes, heart failure, smoking, and prior stroke or VASc (cardiac failure, hypertension, age ≥ 75 [doubled], diabetes, transient ischemic attack (TIA).3,4 In addition to an increased risk of stroke [doubled]-vascular disease, age 65-74 and sex category stroke, AF patients frequently present with comorbid myocardial [female]), and bleeding risk according to HAS-BLED (hypertension, infarction, dementia, and chronic kidney disease.5,6 abnormal renal/liver function, stroke, bleeding history or predisposi- The Global Anticoagulant Registry in the FIELD-AF (GARFIELD- tion, elderly [> 65 years], drugs/alcohol concomitantly) score.12,13 AF) is an ongoing prospective, international, multicentre registry of Case report forms (CRFs) were submitted to the registry- adult patients with newly diagnosed NVAF and one or more additional coordinating center (Dendrite Clinical Systems Ltd, Henley-on- risk factors for stroke.7 Since December 2009, more than 50 000 Thames, UK), and the corresponding data were analyzed by an inde- patients have been enrolled in the registry from 35 countries and pendent statistician. All CRFs were examined by the coordinating patient follow-up is anticipated to end in the third quarter of 2018. center to ascertain completeness and accuracy, and data queries were Major goals of the registry are to identify best practices as well as sent to participating sites. The data used in the study were extracted deficiencies in stroke prevention strategies for AF patients and to from the database on October 18, 2017. describe how patient care has evolved over time. As in all registries, there might be substantial regional and intraregional differences 2.3 | Definitions among baseline characteristics and use of antithrombotic therapies in AC includes vitamin K antagonists (VKAs) and non-vitamin K antago- patients with new NVAF.8 nist oral anticoagulants (NOACs). The term NOAC includes oral direct In 2010, the Global Burden of Disease Study estimated that age- factor Xa inhibitors (FXas) and oral direct thrombin inhibitors (DTIs). adjusted prevalence of AF in Latin America was 737.9 per 100 000 Vascular disease is defined as peripheral artery disease and/or coro- men and 440.3 per 100 000 women, which is higher than the global nary artery disease with a history of acute coronary syndrome average estimated to be 596 per 100 000 men and 373 per 100 000 (ACS).14 Moderate-to-severe chronic kidney disease (CKD) includes women.9 It is likely that the true prevalence of AF, in general, may be stage III to stage V according to the National Kidney Foundation's Kid- even higher due to asymptomatic or unrecognized AF, which is esti- ney Disease Outcomes Quality Initiative guidelines.15 mated to account for up to 27% undiagnosed AF patients.10 In this paper, we analyzed the baseline characteristics, patterns of antithrombotic therapies and 1-year outcomes in four Latin American 2.4 | Ethics statement countries, Argentina, Brazil, Chile, and Mexico that participated in the Independent ethics committee and hospital-based institutional GARFIELD-AF. review board approvals were obtained, as necessary, for the registry protocol. The registry is being performed in accordance with the 2 | METHODS principles of the Declaration of Helsinki, local regulatory require- ments, and the International Conference on Harmonization-Good Pharmacoepidemiological and Clinical Practice guidelines. All 2.1 | Study design and participants patients gave written informed consent to participate. Confidential- GARFIELD-AF is a non-interventional, observational, worldwide study ity and anonymity of all patients recruited into this registry are of NVAF, as described in detail previously.7 Patients (≥18 years) were maintained at all times. diagnosed with AF according to standard local procedures within the previous 6 weeks and had at least 1 additional factor(s) for stroke as 2.5 | Statistical analysis judged by the study investigator. Risk factors were not pre-specified in In this analysis, descriptive summaries of patient baseline characteris- the protocol nor were they limited to the components of existing risk tics were performed for each country, and for all countries taken stratification schemes. The study excluded patients with a transient, together. Continuous variables are presented with mean and SDs, and reversible cause of NVAF, and patients for whom follow-up to 2 years numbers of non-missing observations are included in the tables and was not envisaged or possible.7 Consecutive patients were enrolled figures. Categorical variables are presented using frequencies and per- prospectively into five sequential cohorts (plus one retrospective centages. Baseline differences between countries were evaluated cohort of 5000 patients). Investigator sites were randomly selected11 using χ2 tests for categorical variables, and Students t-test for contin- and were representative of the care settings in each country. uous variables. Percentages are rounded to one decimal place. Occurrences of rate mortality are described using the person-time 2.2 | Data collected at baseline event rate (per 100 person-years) and 95% CI. We
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