Objective: To assess the percentage of patients with normal coronary angiography in a hospital and to determine the predictor variables of this finding. Methods: All elective coronary angiographies performed from April to October 2018 were analyzed, excluding patients with valve diseases and who had a previous catheterization. A total of 503 patients were recruited, divided into 2 groups: Group A for normal coronary arteries, and group B for coronary artery disease. Coronary vessels with diameter ≥2.0mm and with no stenosis ≥40% determined by quantitative coronary angiography were considered normal. After the univariate analysis of the differences between groups, a multivariate analysis was performed by logistic regression, to determine the independent predictors of a normal exam. Results: The clinical characteristics were as follows: mean age of 62 years; 55% male; hypertension present in 86%; diabetes mellitus in 35%; smoking habit reported by 20.5%; dyslipidemia present in 20.5%; and family history of coronary artery disease in 59%. The prevalence of normal coronary angiography was 45%. In the univariate analysis, there were differences between the two groups in regard to sex, age, symptoms, diabetes mellitus and smoking habit. In the multivariate analysis, female sex (OR=3.22; 95%CI 2.20-4.80; p<0.0001), younger age (OR=0.96; 95%CI 0.94-0.98; p<0.0001), absence of diabetes mellitus (OR=0.46; 95%CI 0.30-0.70; p<0.0001), and no smoking habit (OR=0.33; 95%CI 0.19-0.55; p<0.0001) were predictors of normal coronary angiography. Conclusion: The prevalence of normal coronary arteries in this study was high. Female sex, younger age, absence of diabetes mellitus, and no smoking habit were independent predictors of this finding. RESUMO -Objetivo:Averiguar o percentual de pacientes com coronariografia normal em um hospital e determinar as variáveis preditoras desse achado. Métodos: Foram analisadas todas as co ro nariografias eletivas realizadas de abril a outubro de 2018, excluindo pacientes com doenças valvares e que já tinham cateterismo prévio. Foram recrutados 503 pacientes, divididos em 2 grupos: A para coronárias normais e B para doença arterial coronariana. Foram consideradas coronárias normais vasos ≥2,0mm e sem lesões ≥40% pela angiografia coronariana quantitativa. Após análise univariada das diferenças entre os grupos, foi realizada análise multivariada por regressão logística, para determinar os preditores independentes de um exame normal. Resultados: As características clínicas foram as seguintes: média de idade de 62 anos; 55% do sexo masculino; hipertensão arterial sistêmica presente em 86%; diabetes melito em 35%; tabagismo relatado por 20,5%; dislipidemia encontrada em 20,5%; e achado de história familiar de doença arterial coronariana em 59%. A prevalência de coronariografia normal foi de 45%. Na análise univariada, houve diferença entre os dois grupos em relação a sexo, idade, sintomas, diabetes e tabagismo. Na análise multivariada, sexo feminino (RC=3,22; IC95% 2,20-4,80; p<0,0001), idade mais jovem ...
Objectives: The aim of this study was to evaluate the effects of invasive vagal nerve stimulation (VNS) in patients with chronic heart failure (HF) and reduced ejection fraction (HFrEF).Background: Heart failure is characterized by autonomic nervous system imbalance and electrical events that can lead to sudden death. The effects of parasympathetic (vagal) stimulation in patients with HF are not well-established.Methods: From May 1994 to July 2020, a systematic review was performed using PubMed, Embase, and Cochrane Library for clinical trials, comparing VNS with medical therapy for the management of chronic HFrEF (EF ≤ 40%). A meta-analysis of several outcomes and adverse effects was completed, and GRADE was used to assess the level of evidence.Results: Four randomized controlled trials (RCT) and three prospective studies, totalizing 1,263 patients were identified; 756 treated with VNS and 507 with medical therapy. RCT data were included in the meta-analysis (fixed-effect distribution). Adverse effects related to VNS were observed in only 11% of patients. VNS was associated with significant improvement (GRADE = High) in the New York Heart Association (NYHA) functional class (OR, 2.72, 95% CI: 2.07–3.57, p < 0.0001), quality of life (MD −14.18, 95% CI: −18.09 to −10.28, p < 0.0001), a 6-min walk test (MD, 55.46, 95% CI: 39.11–71.81, p < 0.0001) and NT-proBNP levels (MD −144.25, 95% CI: −238.31 to −50.18, p = 0.003). There was no difference in mortality (OR, 1.24; 95% CI: 0.82–1.89, p = 0.43).Conclusions: A high grade of evidence demonstrated that vagal nerve stimulation improves NYHA functional class, a 6-min walk test, quality of life, and NT-proBNP levels in patients with chronic HFrEF, with no differences in mortality.
Nota: Estes posicionamentos se prestam a informar e não a substituir o julgamento clínico do médico que, em última análise, deve determinar o tratamento apropriado para seus pacientes.
Much has been researched on the treatment of chronic coronary artery disease (CAD). [1][2][3] The ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) 4 trial had been long awaited, in the hope that it would answer many remaining questions. Our purpose is to prepare a critical analysis of this document, analyzing its methodology, its results and how it may impact the cardiologist's clinical practice.Initially, when examining the methodology, a difference is noted between what was planned regarding sample size and what was actually accomplished. The sample size was initially calculated to detect an 18% difference in the event rate, when comparing the Invasive Strategy (INV Group) and the Conservative (CON Group) groups over a 4-year period, assuming an event rate of 20% in the second group. In other words, with an event rate of 16.4% in the INV Group, considering a test power of 90% and an alpha error of 0.05, approximately 2,500 patients would be required in each group.However, based on a data analysis performed in 2018, the rate of events was lower than previously estimated, and the researchers were forced to recalculate the sample size to achieve an 18.5% difference when comparing the CON and INV Groups, considering an aggregate event rate of 14% over a 4-year period in the CON Group, with a test power of 83% and a significance level of 0.05. Redoing these calculations in the R statistical software package, for the desired test power of the study, a total of 2,784 patients would be required in each group, totaling more than 5,500 patients. Furthermore, for the difference actually detected between the groups, i.e. 10%, the number of patients required for each group would be 7,500 patients, totaling 15,000.With this simple calculation, it is easy to conclude that the study did not have the statistical power for which it was proposed, since it presumed something that actually did not occur.The analysis of the differences between the two groups was estimated using Cox's proportional regression model. However, the statistical premises of this model were violated for the primary purpose of the study (due to treatment-time interaction, according to the researchers). The statistical analysis plan had specified that the presentation of the results would emphasize non-parametric estimates for cumulative event rate if the assumption of proportional risks were violated, and this actually happened. There were further problems in the study methodology, rendering it extremely complex to be analyzed.Examining the study results, it immediately stands out that 26% of patients in the CON Group underwent coronary angiography, and 21% of patients were revascularized. This means 544 patients out of 2,591, which is not a small number, and although these patients have undergone some type of revascularization, they were analyzed as if they were in the CON Group. Furthermore, the researchers reported that, in the INV Group, a total of 5,337 revascularization procedures were performed (i...
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