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2.
Front Public Health ; 12: 1342490, 2024.
Article En | MEDLINE | ID: mdl-38841682

Introduction: Studies from developed and developing countries showed that the knowledge levels of stroke need improvement. Educational campaigns varied and were of limited influence predominantly because of their short duration and the need for financial support. The study aims to test the impact of a 3-min online video on the knowledge of stroke and factors influencing the knowledge score in four Arab countries. Methods: A cross-sectional web-based pre-post study was conducted in Egypt, Jordan, Lebanon, and the United Arab Emirates. The data were collected using the snowball technique. Participants were adults aged 18 years and above. The questionnaire sequence was conducting a pretest, followed by the educational video explaining stroke occurrence, types, risks, warning signs, preventive measures, and treatment, and finally, a posttest to evaluate the differences in knowledge from baseline. Statistical analysis included paired t-tests comparing pre-post-education stroke knowledge scores, while repeated measures ANOVA, adjusting for covariates, assessed mean changes. Results: The total number of participants was 2,721, mainly younger than 55 years. The majority had a university degree and were not healthcare professionals. A significant improvement was noted in the total knowledge score in all countries from a mean average (Mpretest = 21.11; Mposttest = 23.70) with p < 0.001. Identification of the stroke risks (Mpretest = 7.40; Mposttest = 8.75) and warning signs (Mpretest = 4.19; Mposttest = 4.94), understanding the preventive measures (Mpretest = 5.27; Mposttest = 5.39) and the importance of acting fast (Mpretest = 0.82; Mposttest = 0.85) improved from baseline with (p < 0.001) for all score components. Conclusion: The educational tool successfully enhanced public understanding of stroke risks, the identification of stroke signs, and the critical need for emergency action. The advantages of this video include its short length, free online access, use of evidence-based content in lay language, and reflective images. The ultimate goal remains the long-term improvement of sustainability by mandating full-scale trials.


Health Knowledge, Attitudes, Practice , Stroke , Humans , Male , Female , Stroke/prevention & control , Cross-Sectional Studies , Middle Aged , Adult , Surveys and Questionnaires , Health Education/methods , United Arab Emirates , Egypt , Internet , Video Recording , Aged , Jordan , Lebanon , Young Adult , Middle East , Adolescent
3.
PLoS One ; 19(5): e0302517, 2024.
Article En | MEDLINE | ID: mdl-38722976

OBJECTIVES: Left atrial appendage occlusion during cardiac surgery is a therapeutic option for stroke prevention in patients with atrial fibrillation. The effectiveness and safety of left atrial appendage occlusion have been evaluated in several studies, including the LAAOS-III trial. While these studies have demonstrated efficacy and safety, the long-term economic impact of this surgical technique has not yet been assessed. Here, we aimed to evaluate the cost-effectiveness and cost-utility of left atrial appendage occlusion during cardiac surgery over a long-term time horizon. METHODS: Our study was based on a model representing an hypothetical cohort with the same characteristics as LAAOS-III trial patients. We modelled the incidence of ischemic strokes and systemic embolisms in each intervention arm: "occlusion" and "no-occlusion," using a one-month cycle length with a 20-year time horizon. Regarding occlusion devices, sutures, staples, or an approved surgical occlusion device (AtriClip™-AtriCure, Ohio, USA) could be used. RESULTS: Our model generated an average cost savings of 607 euros per patient and an incremental gain of 0.062 quality-adjusted life years (QALYs), resulting an incremental cost-utility ratio (ICUR) of €-9,775/QALY. The scenario analysis in which occlusion was systematically performed using the AtriClip™ device generated an ICUR of €3,952/QALY gained. CONCLUSIONS: In the base-case analysis, the strategy proved to be more effective and less costly, confirming left atrial appendage occlusion during cardiac surgery as an economically dominant strategy. The scenario analysis also appeared cost-effective, although it did not result in cost savings. This study provides a new perspective on the assessment of the cost-effectiveness of these techniques.


Atrial Appendage , Atrial Fibrillation , Cardiac Surgical Procedures , Cost-Benefit Analysis , Quality-Adjusted Life Years , Humans , Atrial Appendage/surgery , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/economics , Cardiac Surgical Procedures/methods , Atrial Fibrillation/surgery , Atrial Fibrillation/economics , France , Male , Female , Stroke/prevention & control , Stroke/economics , Stroke/etiology , Aged
4.
Open Heart ; 11(1)2024 May 09.
Article En | MEDLINE | ID: mdl-38724265

BACKGROUND: Atrial fibrillation (AF), a common, frequently asymptomatic cardiac arrhythmia, is a major risk factor for stroke. Identification of AF enables effective preventive treatment to be offered, potentially reducing stroke risk by up to two-thirds. There is international consensus that opportunistic AF screening is valuable though uncertainty remains about the optimum screening location and method. Primary care has been identified as a potential location for AF screening using one-lead ECG devices. METHODS: A pilot AF screening programme is in primary care in the south of Ireland. General practitioners (GPs) were recruited from Cork and Kerry. GPs invited patients ≥65 years to undergo AF screening. The screening comprised a one-lead ECG device, Kardia Mobile, blood pressure check and ascertainment of smoking status. Possible AF on one-lead ECG was confirmed with a 12-lead ECG. GPs also recorded information including medical history, current medication and onward referral. The Keele Decision Support tool was used to assess patients for oral anticoagulation (OAC). RESULTS: 3555 eligible patients, attending 52 GPs across 34 GP practices, agreed to undergo screening. 1720 (48%) were female, 1780 (50%) were hypertensive and 285 (8%) were current smokers. On the one-lead ECG, 3282 (92%) were in normal sinus rhythm, 101 (3%) had possible AF and among 124 (4%) the one-lead ECG was unreadable or unclassified. Of the 101 patients with possible AF, 45 (45%) had AF confirmed with 12-lead ECG, an incidence rate of AF of 1.3%. Among the 45 confirmed AF cases, 27 (60%) were commenced on OAC therapy by their GP. CONCLUSION: These findings suggest that AF screening in primary care may prove useful for early detection of AF cases that can be assessed for treatment. One-lead ECG devices may be useful in the detection of paroxysmal AF in this population and setting. Current OAC of AF may be suboptimal.


Atrial Fibrillation , Electrocardiography , Mass Screening , Primary Health Care , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Female , Male , Ireland/epidemiology , Pilot Projects , Primary Health Care/methods , Aged , Mass Screening/methods , Risk Factors , Incidence , Aged, 80 and over , Stroke/prevention & control , Stroke/epidemiology , Stroke/etiology , Predictive Value of Tests
5.
Front Public Health ; 12: 1332884, 2024.
Article En | MEDLINE | ID: mdl-38689768

Background: In this study, we investigated the association between motivation, cognitive load, difficulty, and performance in a stroke education outreach program implemented for middle school students. Methods: Various interactive instructional activities were developed to engage students throughout the program to assess cognitive and intrinsic load arising from learner implementation of various tasks in a stroke education program for middle school kids. Performance was measured using a post-test to assess knowledge gained by the 6th, 7th, and 8th-grade middle school students. A short questionnaire was also administered to collect data on students' motivation using the ARCS model to asses attention, relevance, confidence, and satisfaction. In addition, we evaluated difficulty level and cognitive load. The relationship between performance and motivation was assessed using Pearson's correlation. Results: In our results, there was no significant difference (p > 0.05) in performance between the 6th, 7th, and 8th-grade students. The difference in performance, cognitive load (mental effort and difficulty), or motivation between the 6th, 7th, and 8 t-grade students was not significant (p > 0.05). The correlation between motivation and performance was significant (r = 0.87, p = 0.001), while the correlation between mental effort and performance was not significant (r = 0.34, p = 0.270). Also, the correlation between difficulty and performance was not significant (r = 0.38, p = 0.361). In the ARCS motivation model, attention, and confidence received the lowest mean scores (3.9), while relevance received the highest score (4.3). Conclusion: Our findings reveal the importance of implementing novel activities to enhance students' motivation to improve performance in the implementation of stroke education outreach programs for middle school students.


Cognition , Motivation , Stroke , Students , Humans , Female , Male , Adolescent , Students/psychology , Child , Stroke/prevention & control , Health Education/methods , Surveys and Questionnaires , Schools
6.
Prim Care ; 51(2): 283-297, 2024 Jun.
Article En | MEDLINE | ID: mdl-38692775

Cerebrovascular disease is a common and potentially life-threatening illness if not triaged and/or treated appropriately. The diagnosis is made based on a combination of clinical history and neuroimaging studies. The majority of strokes can be prevented, and this process often begins in the primary care office through the careful assessment of vascular risk factors. Appropriate workup aims to pinpoint a pathogenic mechanism and guide therapy. Stroke treatment has rapidly advanced over the past several years, resulting in improved outcomes.


Ischemic Attack, Transient , Primary Health Care , Stroke , Humans , Ischemic Attack, Transient/diagnosis , Ischemic Attack, Transient/therapy , Stroke/diagnosis , Stroke/therapy , Stroke/prevention & control , Risk Factors , Neuroimaging
8.
Ther Adv Cardiovasc Dis ; 18: 17539447241249886, 2024.
Article En | MEDLINE | ID: mdl-38801157

Atrial fibrillation (AF) accounts for 40% of all cardiac arrhythmias and is associated with a high risk of stroke and systemic thromboembolic complications. Dabigatran, rivaroxaban, apixaban, and edoxaban are direct oral anticoagulants (DOACs) that have been proven to prevent stroke in patients with non-valvular AF. This review summarizes the pharmacokinetics, pharmacodynamics, and drug interactions of DOACs, as well as new data from pharmacogenetic studies of these drugs. This review is aimed at analyzing the scientific literature on the gene polymorphisms involved in the metabolism of DOACs. We searched PubMed, Cochrane, Google Scholar, and CyberLeninka (Russian version) databases with keywords: 'dabigatran', 'apixaban', 'rivaroxaban', 'edoxaban', 'gene polymorphism', 'pharmacogenetics', 'ABCB1', 'CES1', 'SULT1A', 'ABCG2', and 'CYP3A4'. The articles referred for this review include (1) full-text articles; (2) study design with meta-analysis, an observational study in patients taking DOAC; and (3) data on the single-nucleotide polymorphisms and kinetic parameters of DOACs (plasma concentration), or a particular clinical outcome, published in English and Russian languages during the last 10 years. The ages of the patients ranged from 18 to 75 years. Out of 114 reviewed works, 24 were found eligible. As per the available pharmacogenomic data, polymorphisms affecting DOACs are different. This may aid in developing individual approaches to optimize DOAC pharmacotherapy to reduce the risk of hemorrhagic complications. However, large-scale population studies are required to determine the dosage of the new oral anticoagulants based on genotyping. Information on the genetic effects is limited owing to the lack of large-scale studies. Uncovering the mechanisms of the genetic basis of sensitivity to DOACs helps in developing personalized therapy based on patient-specific genetic variants and improves the efficacy and safety of DOACs in the general population.


Gene polymorphism as a cause of hemorrhagic complications in patients with non-valvular atrial fibrillation treated with oral vitamin K-independent anticoagulantsAtrial fibrillation (AF) accounts for 40% of all cardiac arrhythmias and is associated with a high risk of stroke and systemic thromboembolic complications. Dabigatran, rivaroxaban, apixaban, and edoxaban are direct oral anticoagulants (DOACs) that have been proven to prevent stroke in patients with non-valvular AF. This review summarizes the pharmacokinetics, pharmacodynamics, and drug interactions of DOACs, as well as new data from pharmacogenetic studies of these drugs.


Atrial Fibrillation , Hemorrhage , Pharmacogenomic Variants , Humans , Atrial Fibrillation/genetics , Atrial Fibrillation/drug therapy , Atrial Fibrillation/diagnosis , Administration, Oral , Hemorrhage/chemically induced , Hemorrhage/genetics , Risk Factors , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , Anticoagulants/pharmacokinetics , Treatment Outcome , Stroke/prevention & control , Stroke/genetics , Risk Assessment , Phenotype , Polymorphism, Single Nucleotide , Vitamin K/antagonists & inhibitors , Drug Interactions
10.
Dtsch Med Wochenschr ; 149(12): 724-727, 2024 Jun.
Article De | MEDLINE | ID: mdl-38781997

CKD is a common comorbidity in patients with atrial fibrillation. The CHA2DS2-VASc score is not validated in patients with severe CKD and has a low predictive value in dialysis patients. As NOACs are partly eliminated by the kidneys the dosage has to be adapted in CKD. Recent studies indicate an acceptable safety profile for NOACs in CKD. However, larger randomized studies are still lacking. The results from prospective studies with placebo i.e., no anticoagulation therapy, are pending.


Anticoagulants , Atrial Fibrillation , Renal Dialysis , Renal Insufficiency, Chronic , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/therapy , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Stroke/prevention & control
11.
G Ital Cardiol (Rome) ; 25(6): 424-432, 2024 Jun.
Article It | MEDLINE | ID: mdl-38808938

Perioperative stroke and neurological injuries in general are complications that can occur during and after cardiac surgery, particularly in aortic surgery that involves the aortic arch. The overall incidence of early and delayed stroke is about 1% according to recent meta-analyses. This incidence depends on interindividual risk factor profile and type of surgery. In order to reduce cerebrovascular complications during cardiac surgery, a number of preventative measures can be taken, including the evaluation of atherosclerotic plaques, the site of cannulation and neuroprotection strategies. During aortic arch surgery, main strategies for cerebral protection are represented by deep hypothermic circulatory arrest, retrograde and antegrade cerebral perfusion.


Aorta, Thoracic , Cardiac Surgical Procedures , Stroke , Humans , Stroke/prevention & control , Stroke/etiology , Aorta, Thoracic/surgery , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/methods , Risk Factors , Postoperative Complications/prevention & control , Postoperative Complications/etiology , Incidence
12.
Expert Opin Drug Metab Toxicol ; 20(5): 359-376, 2024 May.
Article En | MEDLINE | ID: mdl-38712571

INTRODUCTION: Direct oral anticoagulants (DOAC) are the guideline-recommended therapy for prevention of stroke in atrial fibrillation (AF) and venous thromboembolism. Since approximately 10% of patients using antiepileptic drugs (AED) also receive DOAC, aim of this review is to summarize data about drug-drug interactions (DDI) of DOAC with AED by using data from PubMed until December 2023. AREAS COVERED: Of 49 AED, only 16 have been investigated regarding DDI with DOAC by case reports or observational studies. No increased risk for stroke was reported only for topiramate, zonisamide, pregabalin, and gabapentin, whereas for the remaining 12 AED conflicting results regarding the risk for stroke and bleeding were found. Further 16 AED have the potential for pharmacodynamic or pharmacokinetic DDI, but no data regarding DOAC are available. For the remaining 17 AED it is unknown if they have DDI with DOAC. EXPERT OPINION: Knowledge about pharmacokinetic and pharmacodynamic DDI of AED and DOAC is limited and frequently restricted to in vitro and in vivo findings. Since no data about DDI with DOAC are available for 67% of AED and an increasing number of patients have a combined medication of DOAC and AED, there is an urgent need for research on this topic.


Anticoagulants , Anticonvulsants , Atrial Fibrillation , Drug Interactions , Secondary Prevention , Stroke , Humans , Stroke/prevention & control , Stroke/etiology , Anticonvulsants/administration & dosage , Anticonvulsants/pharmacokinetics , Anticonvulsants/adverse effects , Anticonvulsants/pharmacology , Anticoagulants/administration & dosage , Anticoagulants/pharmacokinetics , Anticoagulants/adverse effects , Anticoagulants/pharmacology , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Administration, Oral , Secondary Prevention/methods , Hemorrhage/chemically induced , Venous Thromboembolism/prevention & control , Primary Prevention/methods , Animals
13.
Int J Cardiol ; 408: 132118, 2024 Aug 01.
Article En | MEDLINE | ID: mdl-38697397

BACKGROUND: To assess long-term effectiveness and safety of edoxaban in Europe. METHODS AND RESULTS: ETNA-AF-Europe, a prospective, multinational, multi-centre, post-authorisation, observational study was conducted in agreement with the European Medicines Agency. The primary and secondary objectives assessed real-world safety (including bleeding and deaths) and effectiveness (including stroke, systemic embolic events and clinical edoxaban use), respectively. Median (interquartile range) age of the 13,164 patients was 75.0 (68.0-80.0) years; CHA2DS2-VASc and HAS-BLED scores were 3.0 (2.0-4.0) and 2.0 (1.0-2.0), respectively. Follow-up duration was 3.98 (3.21-4.05) years. Patients on edoxaban 30 mg (n = 3042) at baseline were older (80.0 vs 73.0 years), more likely assessed as frail by investigators (27.0% vs 6.6%) and had more comorbidities than those on edoxaban 60 mg (n = 9617; missing dosing information for n = 505). Annualised event rates of all-cause and cardiovascular death in the overall population, edoxaban 60 mg and edoxaban 30 mg groups were 4.1%, 2.8% and 8.4%, and 1.0%, 0.7% and 2.0%, respectively. Annualised rates of stroke were relatively constant throughout the follow-up, transient ischaemic attack and systemic embolism were < 1% in the overall population. Rates of any major and major gastrointestinal bleeding were low, with slightly higher rates for edoxaban 30 vs 60 mg group. Intracranial haemorrhage was uncommon (0.2%). CONCLUSIONS: In European patients with AF, long-term therapy with edoxaban is associated with low and relatively constant annualised rates of stroke and major bleeding. Differences in outcomes between the two approved doses are attributable to differences in clinical characteristics.


Atrial Fibrillation , Factor Xa Inhibitors , Pyridines , Thiazoles , Humans , Thiazoles/adverse effects , Thiazoles/therapeutic use , Thiazoles/administration & dosage , Pyridines/adverse effects , Pyridines/administration & dosage , Pyridines/therapeutic use , Aged , Atrial Fibrillation/drug therapy , Male , Female , Europe/epidemiology , Prospective Studies , Factor Xa Inhibitors/adverse effects , Factor Xa Inhibitors/administration & dosage , Factor Xa Inhibitors/therapeutic use , Aged, 80 and over , Treatment Outcome , Follow-Up Studies , Time Factors , Stroke/prevention & control , Stroke/epidemiology , Hemorrhage/chemically induced , Hemorrhage/epidemiology
14.
Trials ; 25(1): 317, 2024 May 14.
Article En | MEDLINE | ID: mdl-38741218

BACKGROUND: Surgical left atrial appendage (LAA) closure concomitant to open-heart surgery prevents thromboembolism in high-risk patients. Nevertheless, high-level evidence does not exist for LAA closure performed in patients with any CHA2DS2-VASc score and preoperative atrial fibrillation or flutter (AF) status-the current trial attempts to provide such evidence. METHODS: The study is designed as a randomized, open-label, blinded outcome assessor, multicenter trial of adult patients undergoing first-time elective open-heart surgery. Patients with and without AF and any CHA2DS2-VASc score will be enrolled. The primary exclusion criteria are planned LAA closure, planned AF ablation, or ongoing endocarditis. Before randomization, a three-step stratification process will sort patients by site, surgery type, and preoperative or expected oral anticoagulation treatment. Patients will undergo balanced randomization (1:1) to LAA closure on top of the planned cardiac surgery or standard care. Block sizes vary from 8 to 16. Neurologists blinded to randomization will adjudicate the primary outcome of stroke, including transient ischemic attack (TIA). The secondary outcomes include a composite outcome of stroke, including TIA, and silent cerebral infarcts, an outcome of ischemic stroke, including TIA, and a composite outcome of stroke and all-cause mortality. LAA closure is expected to provide a 60% relative risk reduction. In total, 1500 patients will be randomized and followed for 2 years. DISCUSSION: The trial is expected to help form future guidelines within surgical LAA closure. This statistical analysis plan ensures transparency of analyses and limits potential reporting biases. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03724318. Registered 26 October 2018, https://clinicaltrials.gov/study/NCT03724318 . PROTOCOL VERSION: https://doi.org/10.1016/j.ahj.2023.06.003 .


Atrial Appendage , Atrial Fibrillation , Cardiac Surgical Procedures , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Stroke , Humans , Atrial Appendage/surgery , Atrial Fibrillation/surgery , Atrial Fibrillation/complications , Stroke/prevention & control , Stroke/etiology , Cardiac Surgical Procedures/adverse effects , Risk Factors , Treatment Outcome , Risk Assessment , Data Interpretation, Statistical , Ischemic Attack, Transient/prevention & control , Ischemic Attack, Transient/etiology , Male , Female , Left Atrial Appendage Closure
15.
Signal Transduct Target Ther ; 9(1): 110, 2024 May 10.
Article En | MEDLINE | ID: mdl-38724491

Previous studies have shown that low platelet count combined with high plasma total homocysteine (tHcy) increased stroke risk and can be lowered by 73% with folic acid. However, the combined role of other platelet activation parameters and the methylenetetrahydrofolate reductase (MTHFR) C677T genotypes on stroke risk and folic acid treatment benefit remain to be examined. This study aimed to investigate if platelet activation parameters and MTHFR genotypes jointly impact folic acid treatment efficacy in first stroke prevention. Data were derived from the China Stroke Primary Prevention Trial. This study includes a total of 11,185 adult hypertensive patients with relevant platelet activation parameters and MTHFR genotype data. When simultaneously considering both platelet activation parameters (plateletcrit, platelet count, mean platelet volume, platelet distribution width) and MTHFR genotypes, patients with both low plateletcrit (Q1) and the TT genotype had the highest stroke incidence rate (5.6%) in the enalapril group. This subgroup significantly benefited from folic acid treatment, with a 66% reduction in first stroke (HR: 0.34; 95% CI: 0.14-0.82; p = 0.016). Consistently, the subgroup with low plateletcrit (Q1) and the CC/CT genotype also benefited from folic acid treatment (HR: 0.40; 95% CI: 0.23-0.70; p = 0.001). In Chinese hypertensive adults, low plateletcrit can identify those who may greatly benefit from folic acid treatment, in particular, those with the TT genotype, a subpopulation known to have the highest stroke risk.


Folic Acid , Genotype , Methylenetetrahydrofolate Reductase (NADPH2) , Stroke , Humans , Methylenetetrahydrofolate Reductase (NADPH2)/genetics , Folic Acid/administration & dosage , Folic Acid/genetics , Stroke/genetics , Stroke/prevention & control , Male , Female , Middle Aged , Aged , Hypertension/genetics , Platelet Activation/genetics , Platelet Activation/drug effects , China/epidemiology , Blood Platelets/metabolism , Blood Platelets/drug effects , Platelet Count , Adult
16.
Arq Bras Cardiol ; 121(3): e20230392, 2024.
Article Pt, En | MEDLINE | ID: mdl-38695465

BACKGROUND: Clinical trials showed the safety of Edoxaban, a non-vitamin K-dependent oral anticoagulant (NOAC), and its efficacy to prevent stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) patients and also to prevent and treat venous thromboembolism. However, additional research is needed to evaluate the safety and effectiveness of Edoxaban in a real-world scenario in the Brazilian population. OBJECTIVE: In order to understand the risks and benefits of Edoxaban use in routine clinical settings, the EdoBRA study is being conducted to gain insight into the safety and effectiveness of Edoxaban use in non-preselected patients with NVAF in Brazil. METHODS: The EdoBRA study is a multicenter, prospective, observational study conducted in 36 sites in Brazil. NVAF patients ≥ 18 years treated with commercially available Edoxaban who initiated treatment for at least 14 days and no longer than 90 days prior to enrollment, and who are not simultaneously participating in any interventional study are eligible for this study. Seven hundred patients are planned to be enrolled and one-year of follow up, with data collections expected at baseline and 3, 6, and 12 months after the study enrollment. The primary safety objective is ISTH Clinically Relevant Bleeding, and the secondary effectiveness objective focuses on relevant cardiovascular outcomes related to NVAF. CONCLUSION: EdoBRA observational study will generate relevant additional information about NOAC Edoxaban on various aspects of patient management in routine care, such as its safety and effectiveness profile in patients with NVAF in Brazil.


FUNDAMENTO: Os ensaios clínicos demonstraram a segurança da Edoxabana, um anticoagulante oral não dependente de vitamina K (NOAC), e a sua eficácia na prevenção de acidente vascular cerebral e embolia sistémica em pacientes com fibrilação atrial não valvar (FANV) e também na prevenção e tratamento de tromboembolismo venoso. No entanto, pesquisas adicionais são necessárias para avaliar a segurança e a eficácia da Edoxabana em um cenário real na população brasileira. OBJETIVO: A fim de compreender os riscos e benefícios do uso da Edoxabana em cenários clínicos de rotina, o estudo EdoBRA está sendo conduzido para obter informações sobre a segurança e eficácia do uso da Edoxabana em pacientes não pré-selecionados com FANV no Brasil. MÉTODOS: O estudo EdoBRA é um estudo multicêntrico, prospectivo e observacional, realizado em 36 centros no Brasil. São elegíveis para este estudo pacientes com FANV, ≥ 18 anos de idade, tratados com Edoxabana disponível comercialmente, que iniciaram o tratamento por pelo menos 14 dias e não mais do que 90 dias antes da data de inclusão no estudo, e que não estão participando de nenhum outro estudo de intervenção. Ao todo, 700 pacientes devem ser inscritos e acompanhados por um ano, com coletas de dados programadas para o período basal e 3, 6 e 12 meses após a inscrição no estudo. O objetivo primário de segurança é o sangramento clinicamente relevante (de acordo com critérios da Sociedade Internacional de Trombose e Hemostasia - ISTH), e o objetivo secundário de eficácia são desfechos cardiovasculares relevantes relacionados à FANV. CONCLUSÃO: O estudo observacional EdoBRA gerará informações adicionais relevantes sobre a Edoxabana enquanto NOAC em diversos aspectos do manejo de pacientes no atendimento clínico de rotina, como perfil de segurança e efetividade em pacientes com FANV no Brasil.


Atrial Fibrillation , Factor Xa Inhibitors , Pyridines , Stroke , Thiazoles , Humans , Atrial Fibrillation/drug therapy , Thiazoles/therapeutic use , Pyridines/therapeutic use , Pyridines/adverse effects , Prospective Studies , Factor Xa Inhibitors/therapeutic use , Brazil , Stroke/prevention & control , Research Design , Time Factors , Treatment Outcome , Hemorrhage/chemically induced , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage
18.
Ann Intern Med ; 177(5): JC57, 2024 May.
Article En | MEDLINE | ID: mdl-38710082

SOURCE CITATION: Joosten LP, van Doorn S, van de Ven PM, et al. Safety of switching from a vitamin K antagonist to a non-vitamin K antagonist oral anticoagulant in frail older patients with atrial fibrillation: results of the FRAIL-AF randomized controlled trial. Circulation. 2024;149:279-289. 37634130.


Anticoagulants , Atrial Fibrillation , Hemorrhage , Vitamin K , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Aged , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Hemorrhage/chemically induced , Vitamin K/antagonists & inhibitors , Frail Elderly , Drug Substitution , Male , Aged, 80 and over , Female , Frailty , Stroke/prevention & control
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