In-Hospital Management and Long-term Clinical Outcomes and Adherence in Patients With Acute Decompensated Heart Failure: Primary Results of the First Brazilian Registry of Heart Failure (BREATHE).

BACKGROUND: Heart failure (HF), a common cause of hospitalization, is associated with poor short-term clinical outcomes. Little is known about the long-term prognoses of patients with HF in Latin America. METHODS: BREATHE was the first nationwide prospective observational study in Brazil that included patients hospitalized due to acute heart failure (HF). Patients were included during 2 time periods: February 2011-December 2012 and June 2016-July 2018 SUGGESTION FOR REPHRASING: In-hospital management, 12-month clinical outcomes and adherence to evidence-based therapies were evaluated. RESULTS: A total of 3013 patients were enrolled at 71 centers in Brazil. At hospital admission, 83.8% had clear signs of pulmonary congestion. The main cause of decompensation was poor adherence to HF medications (27.8%). Among patients with reduced ejection fraction, concomitant use of beta-blockers, renin-angiotensin-aldosterone inhibitors and spironolactone decreased from 44.5% at hospital discharge to 35.2% at 3 months. The cumulative incidence of mortality at 12 months was 27.7%, with 24.3% readmission at 90 days and 44.4% at 12 months. CONCLUSIONS: In this large national prospective registry of patients hospitalized with acute HF, rates of mortality and readmission were higher than those reported globally. Poor adherence to evidence-based therapies was common at hospital discharge and at 12 months of follow-up.

Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial.

Importance: The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. Objective: To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Design, Setting, and Participants: Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Interventions: Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. Main Outcomes and Measures: The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Results: Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Conclusions and Relevance: Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management. Trial Registration: clinicaltrials.gov Identifier: NCT01448642.

Association Between Body Mass Index, Obesity, and Clinical Outcomes Following Coronary Artery Bypass Grafting in Brazil: An Analysis of One Year of Follow-up of BYPASS Registry Patients.

OBJECTIVE: To investigate the association between body mass index (BMI), obesity, clinical outcomes, and mortality following coronary artery bypass grafting (CABG) in Brazil using a large sample with one year of follow-up from the Brazilian Registry of Cardiovascular Surgeries in Adults (or BYPASS) Registry database. METHODS: A multicenter cohort-study enrolled 2,589 patients submitted to isolated CABG and divided them into normal weight (BMI 20.0-24.9 kg/m2), overweight (BMI 25.0-29.9 kg/m2), and obesity (BMI > 30.0 kg/m2) groups. Inpatient postoperative outcomes included the most frequently described complications and events. Collected post-discharge outcomes included rehospitalization and mortality rates within 30 days, six months, and one year of follow-up. RESULTS: Sternal wound infections (SWI) rate was higher in obese compared to normal-weight patients (relative risk [RR]=5.89, 95% confidence interval [CI]=2.37-17.82; P=0.001). Rehospitalization rates in six months after discharge were higher in obesity and overweight groups than in normal weight group (χ=6.03, P=0.049); obese patients presented a 2.2-fold increase in the risk for rehospitalization within six months compared to normal-weight patients (RR=2.16, 95% CI=1.17-4.09; P=0.045). Postoperative complications and mortality rates did not differ among groups during time periods. CONCLUSION: Obesity increased the risk for SWI, leading to higher rehospitalization rates and need for surgical interventions within six months following CABG. Age, female sex, and diabetes were associated with a higher risk of mortality. The obesity paradox remains controversial since BMI may not be sufficient to assess postoperative risk in light of more complex and dynamic evaluations of body composition and physical fitness.

Halofuginone for non-hospitalized adult patients with COVID-19 a multicenter, randomized placebo-controlled phase 2 trial. The HALOS trial.

BACKGROUND: Halofuginone (PJS-539) is an oral prolyl-tRNA synthetase inhibitor that has a potent in vitro activity against SARS-CoV-2 virus. The safety and efficacy of halofuginone in Covid-19 patients has not been studied. METHODS: We conducted a phase II, randomized, double-blind, placebo-controlled, dose ranging, safety and tolerability trial of halofuginone in symptomatic (≤ 7 days), mostly vaccinated, non-hospitalized adults with mild to moderate Covid-19. Patients were randomized in a 1:1:1 ratio to receive halofuginone 0.5mg, 1mg or placebo orally once daily for 10 days. The primary outcome was the decay rate of the SARS-CoV-2 viral load logarithmic curve within 10 days after randomization. RESULTS: From September 25, 2021, to February 3, 2022, 153 patients were randomized. The mean decay rate in SARS-CoV-2 viral load log10 within 10 days was -3.75 (95% CI, -4.11; -3.19) in the placebo group, -3.83 (95% CI, -4.40; -2.27) in the halofuginone 0.5mg group and -4.13 (95% CI, -4.69; -3.57) in the halofuginone 1mg group, with no statistically significant difference in between placebo vs. halofuginone 0.5mg (mean difference -0.08; 95% CI -0.82 to 0.66, p = 0.96) and between placebo vs. halofuginone 1mg (mean difference -0.38; 95% CI, -1.11; 0.36, p = 0.41). There was no difference on bleeding episodes or serious adverse events at 28 days. CONCLUSIONS: Among non-hospitalized adults with mild to moderate Covid-19 halofuginone treatment was safe and well tolerated but did not decrease SARS-CoV-2 viral load decay rate within 10 days.

Adequacy of Fatty Acids Consumption Among Individuals in Secondary Cardiovascular Prevention. / Adequação do Consumo de Ácidos Graxos entre Pacientes em Prevenção Cardiovascular Secundária.

BACKGROUND: Adhering to a diet adequate in macronutrients is crucial for the secondary prevention of cardiovascular diseases. OBJECTIVE: To assess the prevalence of adherence to recommendations for the consumption of dietary fatty acids for the prevention and treatment of cardiovascular diseases and to estimate whether the presence of certain cardiovascular risk factors would be associated with adherence. METHODS: Cross-sectional study using baseline data from 2,358 participants included in the "Brazilian Cardioprotective Nutritional Program Trial". Dietary intake and cardiovascular risk factors were assessed. Adequate intake of polyunsaturated fatty acids (PUFA) was considered as ≥10% of total daily energy intake; for monounsaturated fatty acids (MUFA), 20%; and for saturated fatty acids (SFA), <7% according to the Brazilian Society of Cardiology. A significance level of 5% was considered in the statistical analysis. RESULTS: No participant adhered to all recommendations simultaneously, and more than half (1,482 [62.9%]) did not adhere to any recommendation. Adherence exclusively to the SFA recommendation was the most prevalent, fulfilled by 659 (28%) participants, followed by adherence exclusively to the PUFA (178 [7.6%]) and MUFA (5 [0.2%]) recommendations. There was no association between the number of comorbidities and adherence to nutritional recommendations (p = 0.269). Participants from the Brazilian Northeast region showed a higher proportion of adherence to SFA consumption recommendations (38.42%) and lower adherence to PUFA intake (3.52%) (p <0.001) compared to other regions. CONCLUSIONS: Among the evaluated sample, there was low adherence to nutritional recommendations for dietary fatty acid consumption.

FUNDAMENTO: A adesão à uma alimentação adequada em macronutrientes é fundamental para a prevenção secundária de doenças cardiovasculares. OBJETIVO: Avaliar a prevalência de adesão às recomendações de consumo de ácidos graxos para prevenção e tratamento de doenças cardiovasculares, e estimar se a presença de determinados fatores de risco cardiovascular estaria associada à adesão. MÉTODOS: Estudo transversal com os dados de linha de base de 2358 participantes do estudo "Brazilian Cardioprotective Nutritional Program Trial". Dados de consumo alimentar, e fatores de risco cardiovascular foram avaliados. Foi considerada, de acordo com a Sociedade Brasileira de Cardiologia, uma ingestão adequada de ácidos graxos poli-insaturados (AGPI) ≥10% do consumo total de energia diária, para ácidos graxos monoinsaturados (AGM), 20% e para ácidos graxos saturados (AGS), <7%. Na análise estatística foi considerando nível de significância de 5%. RESULTADOS: Nenhum participante aderiu a todas as recomendações de forma simultânea e mais da metade (1482 [62,9%]) não aderiu a nenhuma recomendação. A adesão exclusivamente à recomendação de AGS foi a mais prevalente, sendo cumprida por 659 (28%) dos participantes, seguida da adesão exclusivamente à recomendação de AGP (178 [7,6%]) e de AGM (5 [0,2%]). Não houve associação entre o número de comorbidades e a adesão às recomendações nutricionais (p =0,269). Os participantes da região Nordeste do país apresentaram maior proporção de adesão às recomendações para consumo de AGS (38,42%), e menor para ingestão de AGPI (3,52%) (p <0,001) em comparação às demais. CONCLUSÕES: Na amostra avaliada, evidenciou-se baixa adesão às recomendações nutricionais para consumo de ácidos graxos.

Attributable mortality due to nosocomial sepsis in Brazilian hospitals: a case-control study.

BACKGROUND: Nosocomial sepsis is a major healthcare issue, but there are few data on estimates of its attributable mortality. We aimed to estimate attributable mortality fraction (AF) due to nosocomial sepsis. METHODS: Matched 1:1 case-control study in 37 hospitals in Brazil. Hospitalized patients in participating hospitals were included. Cases were hospital non-survivors and controls were hospital survivors, which were matched by admission type and date of discharge. Exposure was defined as occurrence of nosocomial sepsis, defined as antibiotic prescription plus presence of organ dysfunction attributed to sepsis without an alternative reason for organ failure; alternative definitions were explored. Main outcome measurement was nosocomial sepsis-attributable fractions, estimated using inversed-weight probabilities methods using generalized mixed model considering time-dependency of sepsis occurrence. RESULTS: 3588 patients from 37 hospitals were included. Mean age was 63 years and 48.8% were female at birth. 470 sepsis episodes occurred in 388 patients (311 in cases and 77 in control group), with pneumonia being the most common source of infection (44.3%). Average AF for sepsis mortality was 0.076 (95% CI 0.068-0.084) for medical admissions; 0.043 (95% CI 0.032-0.055) for elective surgical admissions; and 0.036 (95% CI 0.017-0.055) for emergency surgeries. In a time-dependent analysis, AF for sepsis rose linearly for medical admissions, reaching close to 0.12 on day 28; AF plateaued earlier for other admission types (0.04 for elective surgery and 0.07 for urgent surgery). Alternative sepsis definitions yield different estimates. CONCLUSION: The impact of nosocomial sepsis on outcome is more pronounced in medical admissions and tends to increase over time. The results, however, are sensitive to sepsis definitions.

Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn: protocol and statistical analysis plan. / Antivirais para pacientes adultos hospitalizados com infecção por SARS-CoV-2: Um estudo de Fase II/III, randomizado, multicêntrico, controlado por placebo, adaptativo, com múltiplos braços e estágios. COALITION COVID-19 BRAZIL IX - REVOLUTIOn: protocolo e plano de análise estatística.

Repurposed drugs are important in resource-limited settings because the interventions are more rapidly available, have already been tested safely in other populations and are inexpensive. Repurposed drugs are an effective solution, especially for emerging diseases such as COVID-19. The REVOLUTIOn trial has the objective of evaluating three repurposed antiviral drugs, atazanavir, daclatasvir and sofosbuvir, already used for HIV- and hepatitis C virus-infected patients in a randomized, placebo-controlled, adaptive, multiarm, multistage study. The drugs will be tested simultaneously in a Phase II trial to first identify whether any of these drugs alone or in combination reduce the viral load. If they do, a Phase III trial will be initiated to investigate if these medications are capable of increasing the number of days free respiratory support. Participants must be hospitalized adults aged ≥ 18 years with initiation of symptoms ≤ 9 days and SpO2 ≤ 94% in room air or a need for supplemental oxygen to maintain an SpO2 > 94%. The expected total sample size ranges from 252 to 1,005 participants, depending on the number of stages that will be completed in the study. Hence, the protocol is described here in detail together with the statistical analysis plan. In conclusion, the REVOLUTIOn trial is designed to provide evidence on whether atazanavir, daclatasvir or sofosbuvir decrease the SARS-CoV-2 load in patients with COVID-19 and increase the number of days patients are free of respiratory support. In this protocol paper, we describe the rationale, design, and status of the trial. ClinicalTrials.gov identifier: NCT04468087.

Os medicamentos reaproveitados são importantes em contextos de recursos limitados porque as intervenções estão mais rapidamente disponíveis, já foram testadas com segurança em outras populações e são, em geral, mais baratas. Os medicamentos reaproveitados são uma solução eficaz, especialmente para doenças emergentes, como a COVID-19. O estudo REVOLUTIOn visa avaliar três medicamentos antivirais reaproveitados: atazanavir, daclatasvir e sofosbuvir, já utilizados em pacientes infectados pelo HIV ou pelo vírus da hepatite C, em um estudo randomizado, controlado por placebo, adaptativo, multibraço e em múltiplos estágios. Os medicamentos serão testados simultaneamente em um ensaio de Fase II para primeiro identificar se algum deles, isoladamente ou em combinação, reduz a carga viral. Se reduzirem, será iniciado um estudo de Fase III para investigar se tais medicamentos são capazes de aumentar o número de dias sem suporte respiratório. Os participantes devem ser adultos hospitalizados com idade ≥ 18 anos com início dos sintomas ≤ 9 dias e saturação de oxigênio ≤ 94% em ar ambiente ou necessidade de oxigênio suplementar para manter saturação de oxigênio > 94%. O tamanho total esperado da amostra varia entre 252 e 1.005 participantes, dependendo do número de estágios que serão concluídos no estudo. Assim, o protocolo é aqui descrito em detalhes, juntamente do plano de análise estatística. Em conclusão, o estudo REVOLUTIOn foi concebido para fornecer evidências se o atazanavir, o daclatasvir ou o sofosbuvir reduzem a carga viral de SARS-CoV-2 em pacientes com COVID-19 e aumentam o número de dias em que os pacientes ficam sem suporte respiratório. Neste artigo de protocolo, descrevem-se a fundamentação, o desenho e a situação do ensaio. Identificador do ClinicalTrials.gov: NCT04468087.

Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial.

BACKGROUND: Nut consumption has been related to improvements on cardiometabolic parameters and reduction in the severity of atherosclerosis mainly in primary cardiovascular prevention. The objective of this trial is to evaluate the effects of the Brazilian Cardioprotective Diet (DIeta CArdioprotetora Brasileira, DICA Br) based on consumption of inexpensive locally accessible foods supplemented or not with mixed nuts on cardiometabolic features in patients with previous myocardial infarction (MI). METHODS: DICA-NUTS study is a national, multicenter, randomized 16-week follow-up clinical trial. Patients over 40 years old with diagnosis of previous MI in the last 2 to 6 months will be recruited (n = 388). A standardized questionnaire will be applied to data collection and blood samples will be obtained. Patients will be allocated in two groups: Group 1: DICA Br supplemented with 30 g/day of mixed nuts (10 g of peanuts, 10 g of cashew, 10 g of Brazil nuts); and Group 2: only DICA Br. The primary outcome will consist of LDL cholesterol means (in mg/dL) after 16 weeks of intervention. Secondary outcomes will consist of other markers of lipid profile, glycemic profile, and anthropometric data. DISCUSSION: It is expected that DICA Br supplemented with mixed nuts have superior beneficial effects on cardiometabolic parameters in patients after a MI, when compared to DICA Br. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03728127 . First register: November 1, 2018; Last update: June 16, 2021. World Health Organization Universal Trial Number (WHO-UTN): U1111-1259-8105.

[Quality of diet and daily spending on food by adults with cardiovascular disease in Brazil]. / Qualidade da dieta e despesa diária com alimentação em adultos com doença cardiovascular no Brasil.

Adherence to a healthy diet depends on factors such as food prices, while studies in developed countries have identified higher costs of more nutritional foods. The current study aimed to assess the direct food expenditures by adults with cardiovascular disease in Brazil, investigating the relationship between cost and quality of diet. The study used data from a randomized clinical trial, the BALANCE Program. The current study is a cross-sectional baseline analysis of participants with high adherence to the trial, conducted in 35 sites in all five major geographic regions of Brazil. Food consumption by 1,160 individuals was collected with a 24-hour dietary recall (24HR), quality of diet was measured with the Diet Quality Index Revised (DQI-R), and direct food costs were estimated from market prices. No significant differences were observed between tertiles of adherence in the direct costs of food or individual characteristics. When all the 24HR were analyzed, there was no correlation between cost and quality of diet (r = 0.38; p = 0.17), while analysis by tertiles showed a weak correlation in the lowest tertile of adherence (r = -0.112; p = 0.03). The study showed absence of differences between direct costs of healthy versus unhealthy foods, a finding that can serve as an incentive for adherence to food recommendations in Brazil, thereby minimizing barriers to the adoption of healthy lifestyles.

A adesão a uma alimentação saudável depende de fatores como os preços dos alimentos, sendo que alguns estudos conduzidos em países desenvolvidos apontam para um maior custo de uma alimentação de melhor qualidade nutricional. O objetivo do presente trabalho foi avaliar o custo direto da alimentação de indivíduos adultos com doença cardiovascular no Brasil, investigando a relação entre o custo e a qualidade da dieta. Foram utilizados os dados de um ensaio clínico randomizado, o BALANCE Program. A investigação atual é uma análise transversal no momento inicial dos participantes com alta adesão ao estudo realizado em 35 centros das cinco regiões brasileiras. O consumo alimentar de amostra com 1.160 indivíduos foi coletado pelo recordatório alimentar de 24 horas (R24h), a avaliação da qualidade da dieta pelo Índice da Qualidade da Dieta Revisado (IQD-R) e os custos diretos da alimentação foram estimados por meio de preços de mercado. Não foram observadas diferenças significativas no custo direto da alimentação ou características dos indivíduos entre os tercis de adesão. Quando analisados todos os recordatórios não houve correlação entre custo e qualidade da dieta (r = 0,38; p = 0,17), já a análise por tercis mostrou fraca correlação entre o menor tercil de adesão (r = -0,112; p = 0,03). O presente estudo apontou ausência de diferenças entre os custos diretos da alimentação classificada como saudável e daquela com a pior qualidade nutricional, o que pode ser um incentivo à adesão às orientações alimentares no Brasil, minimizando barreiras à adoção de estilos de vida saudáveis.

La adhesión a una alimentación saludable depende de factores como los precios de los alimentos, siendo que algunos estudios realizados en países desarrollados apuntan hacia un mayor coste de una alimentación de mejor calidad nutricional. El objetivo del presente estudio fue evaluar el coste directo de la alimentación en individuos adultos con enfermedad cardiovascular en Brasil, investigando la relación entre el coste y la calidad de la dieta. Se utilizaron los datos de un ensayo clínico aleatorio, el BALANCE Program. La investigación actual es un análisis transversal desde el principio con participantes de alta adhesión al estudio, realizado en 35 centros de las cinco regiones brasileñas. El consumo alimentario de la muestra con 1.160 individuos fue recogido mediante el recordatorio alimentario de 24 horas (R24h), la evaluación de la calidad de la dieta se evaluó mediante el Índice de Calidad de la Dieta Revisado (IQD-R por sus siglas en portugués) y los costes directos de la alimentación se estimaron mediante precios de mercado. No se observaron diferencias significativas en el coste directo de la alimentación o características de los individuos entre los terciles de adhesión. Cuando se analizaron todos los recordatorios no hubo correlación entre coste y calidad de la dieta (r = 0,38; p = 0,17), ya en el análisis por terciles hubo una débil correlación entre el menor tercil de adhesión (r = -0,112; p = 0,03). El presente estudio apuntó una ausencia de diferencias entre los costes directos de la alimentación clasificada como saludable y aquella con peor calidad nutricional, lo que puede ser un incentivo para la adhesión a las orientaciones alimentarias en Brasil, minimizando barreras para la adopción de estilos de vida saludables.

Valve Heart Surgery in Brazil - The BYPASS Registry Analysis.

OBJECTIVE: To analyze the profile and outcomes of patients who underwent valve heart surgery in Brazil, using information retrieved from the Brazilian Registry of Cardiovascular Surgeries in Adults (BYPASS Registry) database. METHODS: This is a multicenter cohort study, evaluating 920 patients submitted to heart valve surgery. Demographics and postoperative clinical outcomes were assessed and compared to estimate mortality risk using the European System for Cardiac Operative Risk Evaluation (EuroSCORE). RESULTS: Isolated aortic valve replacement was the most frequently performed surgery (34%), followed by isolated mitral valve replacement (24.9%). Valve repair was performed in 21% of mitral procedures. Minimally invasive access was performed in 1.6% and the most frequent postoperative complications were arrhythmias (22.6%), infections (5.7%), and low-output syndrome (5.1%). Operations covered by the public health system accounted for 80.8% and the hospital mortality rate was 7.3%. CONCLUSION: The most frequent isolated valve surgery in Brazil is the aortic valve replacement by conventional open access and the rheumatic disease is still the main etiology for valve surgery. The BYPASS Registry has a fundamental role to provide information on the profile of patients with valve heart disease in our country in order to delineate adequate strategies for health promotion and resource allocation for cardiac surgery.

Association Between Body Mass Index, Obesity, and Clinical Outcomes Following Coronary Artery Bypass Grafting in Brazil: An Analysis of One Year of Follow-up of BYPASS Registry Patients

ABSTRACT Objective: To investigate the association between body mass index (BMI), obesity, clinical outcomes, and mortality following coronary artery bypass grafting (CABG) in Brazil using a large sample with one year of follow-up from the Brazilian Registry of Cardiovascular Surgeries in Adults (or BYPASS) Registry database. Methods: A multicenter cohort-study enrolled 2,589 patients submitted to isolated CABG and divided them into normal weight (BMI 20.0-24.9 kg/m2), overweight (BMI 25.0-29.9 kg/m2), and obesity (BMI > 30.0 kg/m2) groups. Inpatient postoperative outcomes included the most frequently described complications and events. Collected post-discharge outcomes included rehospitalization and mortality rates within 30 days, six months, and one year of follow-up. Results: Sternal wound infections (SWI) rate was higher in obese compared to normal-weight patients (relative risk [RR]=5.89, 95% confidence interval [CI]=2.37-17.82; P=0.001). Rehospitalization rates in six months after discharge were higher in obesity and overweight groups than in normal weight group (χ2=6.03, P=0.049); obese patients presented a 2.2-fold increase in the risk for rehospitalization within six months compared to normal-weight patients (RR=2.16, 95% CI=1.17-4.09; P=0.045). Postoperative complications and mortality rates did not differ among groups during time periods. Conclusion: Obesity increased the risk for SWI, leading to higher rehospitalization rates and need for surgical interventions within six months following CABG. Age, female sex, and diabetes were associated with a higher risk of mortality. The obesity paradox remains controversial since BMI may not be sufficient to assess postoperative risk in light of more complex and dynamic evaluations of body composition and physical fitness.

Adequação do consumo de ácidos graxos entre pacientes em prevenção cardiovascular secundária / Adequacy of Fatty Acids Consumption Among Individuals in Secondary Cardiovascular Prevention

FUNDAMENTO: A adesão à uma alimentação adequada em macronutrientes é fundamental para a prevenção secundária de doenças cardiovasculares. OBJETIVO: Avaliar a prevalência de adesão às recomendações de consumo de ácidos graxos para prevenção e tratamento de doenças cardiovasculares, e estimar se a presença de determinados fatores de risco cardiovascular estaria associada à adesão. MÉTODOS: Estudo transversal com os dados de linha de base de 2358 participantes do estudo "Brazilian Cardioprotective Nutritional Program Trial". Dados de consumo alimentar, e fatores de risco cardiovascular foram avaliados. Foi considerada, de acordo com a Sociedade Brasileira de Cardiologia, uma ingestão adequada de ácidos graxos poli-insaturados (AGPI) ≥10% do consumo total de energia diária, para ácidos graxos monoinsaturados (AGM), 20% e para ácidos graxos saturados (AGS), <7%. Na análise estatística foi considerando nível de significância de 5%. RESULTADOS: Nenhum participante aderiu a todas as recomendações de forma simultânea e mais da metade (1482 [62,9%]) não aderiu a nenhuma recomendação. A adesão exclusivamente à recomendação de AGS foi a mais prevalente, sendo cumprida por 659 (28%) dos participantes, seguida da adesão exclusivamente à recomendação de AGP (178 [7,6%]) e de AGM (5 [0,2%]). Não houve associação entre o número de comorbidades e a adesão às recomendações nutricionais (p =0,269). Os participantes da região Nordeste do país apresentaram maior proporção de adesão às recomendações para consumo de AGS (38,42%), e menor para ingestão de AGPI (3,52%) (p <0,001) em comparação às demais. CONCLUSÕES: Na amostra avaliada, evidenciou-se baixa adesão às recomendações nutricionais para consumo de ácidos graxos.

Coronary Artery Bypass Surgery in Brazil: Analysis of the National Reality Through the BYPASS Registry.

INTRODUCTION: Coronary artery bypass grafting (CABG) is the most frequently performed heart surgery in Brazil. Recent international guidelines recommend that national societies establish a database on the practice and results of CABG. In anticipation of the recommendation, the BYPASS Registry was introduced in 2015. OBJECTIVE: To analyze the profile, risk factors and outcomes of patients undergoing CABG in Brazil, as well as to examine the predominant surgical strategy, based on the data included in the BYPASS Registry. METHODS: A cross-sectional study of 2292 patients undergoing CABG surgery and cataloged in the BYPASS Registry up to November 2018. Demographic data, clinical presentation, operative variables, and postoperative hospital outcomes were analyzed. RESULTS: Patients referred to CABG in Brazil are predominantly male (71%), with prior myocardial infarction in 41.1% of cases, diabetes in 42.5%, and ejection fraction lower than 40% in 9.7%. The Heart Team indicated surgery in 32.9% of the cases. Most of the patients underwent cardiopulmonary bypass (87%), and cardioplegia was the strategy of myocardial protection chosen in 95.2% of the cases. The left internal thoracic artery was used as a graft in 91% of the cases; the right internal thoracic artery, in 5.6%; and the radial artery in 1.1%. The saphenous vein graft was used in 84.1% of the patients, being the only graft employed in 7.7% of the patients. The median number of coronary vessels treated was 3. Operative mortality was 2.8%, and the incidence of cerebrovascular accident was 1.2%. CONCLUSION: CABG data in Brazil provided by the BYPASS Registry analysis are representative of our national reality and practice. This database constitutes an important reference for indications and comparisons of therapeutic procedures, as well as to propose subsequent models to improve patient safety and the quality of surgical practice in the country.

Existing capacity for renal replacement therapy and site-specific practices for managing acute kidney injury at centers participating in the BaSICS trial. / Capacidade instalada de terapêutica substitutiva da função renal e práticas locais na abordagem da lesão renal aguda em centros participantes do estudo BaSICS.

OBJECTIVE: To investigate the existing capacity for renal replacement therapy and site-specific practices for managing acute kidney injury at centers participating in the BaSICS trial. METHODS: A questionnaire was provided to the chairs of 61 intensive care units enrolled in a randomized clinical trial in Brazil. A total of 124 physicians completed the questionnaire. RESULTS: Approximately 15% of the patients admitted to the analyzed intensive care units received renal replacement therapy at the time of data collection. At least one renal replacement method was available in all of the analyzed units. Continuous methods were available more frequently at the private units than at the public units. The time from indication to onset of treatment was longer at the public units than at private units. The main obstacles to treatment initiation at public intensive care units were related to the availability of equipment and personnel, while the main bottleneck at private units was the nephrologist assessment. A considerable proportion of the participants stated that they would change their approach to renal replacement therapy if there were no limitations on the availability of methods in their units. CONCLUSION: There was wide variation in the availability of resources for renal replacement therapy and in the management of acute kidney injury in Brazilian intensive care units. This information should be taken into account when planning clinical trials focused on this topic in Brazil.

OBJETIVO: Avaliar a capacidade instalada de terapêutica substitutiva da função renal e práticas locais na abordagem da lesão renal aguda em centros participantes do estudo BaSICS. MÉTODOS: Um questionário foi enviado aos coordenadores de 61 unidades de terapia intensiva participantes de um ensaio clínico randomizado brasileiro. Um total de 124 médicos respondeu ao questionário. RESULTADOS: No momento do questionário, 15% dos pacientes nas unidades de terapia intensiva participantes encontravam-se em terapêutica substitutiva da função renal. Todas as unidades de terapia intensiva dispunham de, pelo menos, um método de terapêutica substitutiva da função renal. Métodos contínuos estavam mais disponíveis em unidades privadas do que nas públicas. O tempo entre indicação do método e início da terapia foi maior em unidades de terapia intensiva públicas do que nas privadas. Os principais obstáculos para início do método em unidades de terapia intensiva públicas incluíam disponibilidade de maquinário e pessoal, enquanto que o principal gargalo em unidades de terapia intensiva privadas foi a avaliação do nefrologista. Parte importante dos médicos avaliados mudaria sua prática de manuseio de terapêutica substitutiva da função renal caso não houvesse limitação de métodos de terapêutica substitutiva da função renal em suas unidades. CONCLUSÃO: Existe ampla variedade na disponibilidade de recursos para terapêutica substitutiva da função renal e nas práticas de manuseio da lesão renal aguda em unidades de terapia intensiva brasileiras. Estas informações devem ser levadas em conta ao planejarem-se ensaios clínicos sobre o assunto no contexto brasileiro.

Antivirais para pacientes adultos hospitalizados com infecção por SARS-CoV-2: Um estudo de Fase II/III, randomizado, multicêntrico, controlado por placebo, adaptativo, com múltiplos braços e estágios. COALITION COVID-19 BRAZIL IX ­ REVOLUTIOn: protocolo e plano de análise estatística

Os medicamentos reaproveitados são importantes em contextos de recursos limitados porque as intervenções estão mais rapidamente disponíveis, já foram testadas com segurança em outras populações e são, em geral, mais baratas. Os medicamentos reaproveitados são uma solução eficaz, especialmente para doenças emergentes, como a COVID-19. O estudo REVOLUTIOn visa avaliar três medicamentos antivirais reaproveitados: atazanavir, daclatasvir e sofosbuvir, já utilizados em pacientes infectados pelo HIV ou pelo vírus da hepatite C, em um estudo randomizado, controlado por placebo, adaptativo, multibraço e em múltiplos estágios. Os medicamentos serão testados simultaneamente em um ensaio de Fase II para primeiro identificar se algum deles, isoladamente ou em combinação, reduz a carga viral. Se reduzirem, será iniciado um estudo de Fase III para investigar se tais medicamentos são capazes de aumentar o número de dias sem suporte respiratório. Os participantes devem ser adultos hospitalizados com idade ≥ 18 anos com início dos sintomas ≤ 9 dias e saturação de oxigênio ≤ 94% em ar ambiente ou necessidade de oxigênio suplementar para manter saturação de oxigênio > 94%. O tamanho total esperado da amostra varia entre 252 e 1.005 participantes, dependendo do número de estágios que serão concluídos no estudo. Assim, o protocolo é aqui descrito em detalhes, juntamente do plano de análise estatística. Em conclusão, o estudo REVOLUTIOn foi concebido para fornecer evidências se o atazanavir, o daclatasvir ou o sofosbuvir reduzem a carga viral de SARS-CoV-2 em pacientes com COVID-19 e aumentam o número de dias em que os pacientes ficam sem suporte respiratório. Neste artigo de protocolo, descrevem-se a fundamentação, o desenho e a situação do ensaio.

Antivirais para pacientes adultos hospitalizados com infecção por SARS-CoV-2: Um estudo de Fase II/III, randomizado, multicêntrico, controlado por placebo, adaptativo, com múltiplos braços e estágios. COALITION COVID-19 BRAZIL IX - REVOLUTIOn: protocolo e plano de análise estatística / Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn: protocol and statistical analysis plan

RESUMO Os medicamentos reaproveitados são importantes em contextos de recursos limitados porque as intervenções estão mais rapidamente disponíveis, já foram testadas com segurança em outras populações e são, em geral, mais baratas. Os medicamentos reaproveitados são uma solução eficaz, especialmente para doenças emergentes, como a COVID-19. O estudo REVOLUTIOn visa avaliar três medicamentos antivirais reaproveitados: atazanavir, daclatasvir e sofosbuvir, já utilizados em pacientes infectados pelo HIV ou pelo vírus da hepatite C, em um estudo randomizado, controlado por placebo, adaptativo, multibraço e em múltiplos estágios. Os medicamentos serão testados simultaneamente em um ensaio de Fase II para primeiro identificar se algum deles, isoladamente ou em combinação, reduz a carga viral. Se reduzirem, será iniciado um estudo de Fase III para investigar se tais medicamentos são capazes de aumentar o número de dias sem suporte respiratório. Os participantes devem ser adultos hospitalizados com idade ≥ 18 anos com início dos sintomas ≤ 9 dias e saturação de oxigênio ≤ 94% em ar ambiente ou necessidade de oxigênio suplementar para manter saturação de oxigênio > 94%. O tamanho total esperado da amostra varia entre 252 e 1.005 participantes, dependendo do número de estágios que serão concluídos no estudo. Assim, o protocolo é aqui descrito em detalhes, juntamente do plano de análise estatística. Em conclusão, o estudo REVOLUTIOn foi concebido para fornecer evidências se o atazanavir, o daclatasvir ou o sofosbuvir reduzem a carga viral de SARS-CoV-2 em pacientes com COVID-19 e aumentam o número de dias em que os pacientes ficam sem suporte respiratório. Neste artigo de protocolo, descrevem-se a fundamentação, o desenho e a situação do ensaio. Identificador do ClinicalTrials.gov:NCT04468087

ABSTRACT Repurposed drugs are important in resource-limited settings because the interventions are more rapidly available, have already been tested safely in other populations and are inexpensive. Repurposed drugs are an effective solution, especially for emerging diseases such as COVID-19. The REVOLUTIOn trial has the objective of evaluating three repurposed antiviral drugs, atazanavir, daclatasvir and sofosbuvir, already used for HIV- and hepatitis C virus-infected patients in a randomized, placebo-controlled, adaptive, multiarm, multistage study. The drugs will be tested simultaneously in a Phase II trial to first identify whether any of these drugs alone or in combination reduce the viral load. If they do, a Phase III trial will be initiated to investigate if these medications are capable of increasing the number of days free respiratory support. Participants must be hospitalized adults aged ≥ 18 years with initiation of symptoms ≤ 9 days and SpO2 ≤ 94% in room air or a need for supplemental oxygen to maintain an SpO2 > 94%. The expected total sample size ranges from 252 to 1,005 participants, depending on the number of stages that will be completed in the study. Hence, the protocol is described here in detail together with the statistical analysis plan. In conclusion, the REVOLUTIOn trial is designed to provide evidence on whether atazanavir, daclatasvir or sofosbuvir decrease the SARS-CoV-2 load in patients with COVID-19 and increase the number of days patients are free of respiratory support. In this protocol paper, we describe the rationale, design, and status of the trial. ClinicalTrials.gov identifier:NCT04468087

Qualidade da dieta e despesa diária com alimentação em adultos com doença cardiovascular no Brasil / Quality of diet and daily spending on food by adults with cardiovascular disease in Brazil / Calidad de la dieta y gasto diario en alimentación de adultos con enfermedad cardiovascular en Brasil

A adesão a uma alimentação saudável depende de fatores como os preços dos alimentos, sendo que alguns estudos conduzidos em países desenvolvidos apontam para um maior custo de uma alimentação de melhor qualidade nutricional. O objetivo do presente trabalho foi avaliar o custo direto da alimentação de indivíduos adultos com doença cardiovascular no Brasil, investigando a relação entre o custo e a qualidade da dieta. Foram utilizados os dados de um ensaio clínico randomizado, o BALANCE Program. A investigação atual é uma análise transversal no momento inicial dos participantes com alta adesão ao estudo realizado em 35 centros das cinco regiões brasileiras. O consumo alimentar de amostra com 1.160 indivíduos foi coletado pelo recordatório alimentar de 24 horas (R24h), a avaliação da qualidade da dieta pelo Índice da Qualidade da Dieta Revisado (IQD-R) e os custos diretos da alimentação foram estimados por meio de preços de mercado. Não foram observadas diferenças significativas no custo direto da alimentação ou características dos indivíduos entre os tercis de adesão. Quando analisados todos os recordatórios não houve correlação entre custo e qualidade da dieta (r = 0,38; p = 0,17), já a análise por tercis mostrou fraca correlação entre o menor tercil de adesão (r = -0,112; p = 0,03). O presente estudo apontou ausência de diferenças entre os custos diretos da alimentação classificada como saudável e daquela com a pior qualidade nutricional, o que pode ser um incentivo à adesão às orientações alimentares no Brasil, minimizando barreiras à adoção de estilos de vida saudáveis.

Adherence to a healthy diet depends on factors such as food prices, while studies in developed countries have identified higher costs of more nutritional foods. The current study aimed to assess the direct food expenditures by adults with cardiovascular disease in Brazil, investigating the relationship between cost and quality of diet. The study used data from a randomized clinical trial, the BALANCE Program. The current study is a cross-sectional baseline analysis of participants with high adherence to the trial, conducted in 35 sites in all five major geographic regions of Brazil. Food consumption by 1,160 individuals was collected with a 24-hour dietary recall (24HR), quality of diet was measured with the Diet Quality Index Revised (DQI-R), and direct food costs were estimated from market prices. No significant differences were observed between tertiles of adherence in the direct costs of food or individual characteristics. When all the 24HR were analyzed, there was no correlation between cost and quality of diet (r = 0.38; p = 0.17), while analysis by tertiles showed a weak correlation in the lowest tertile of adherence (r = -0.112; p = 0.03). The study showed absence of differences between direct costs of healthy versus unhealthy foods, a finding that can serve as an incentive for adherence to food recommendations in Brazil, thereby minimizing barriers to the adoption of healthy lifestyles.

La adhesión a una alimentación saludable depende de factores como los precios de los alimentos, siendo que algunos estudios realizados en países desarrollados apuntan hacia un mayor coste de una alimentación de mejor calidad nutricional. El objetivo del presente estudio fue evaluar el coste directo de la alimentación en individuos adultos con enfermedad cardiovascular en Brasil, investigando la relación entre el coste y la calidad de la dieta. Se utilizaron los datos de un ensayo clínico aleatorio, el BALANCE Program. La investigación actual es un análisis transversal desde el principio con participantes de alta adhesión al estudio, realizado en 35 centros de las cinco regiones brasileñas. El consumo alimentario de la muestra con 1.160 individuos fue recogido mediante el recordatorio alimentario de 24 horas (R24h), la evaluación de la calidad de la dieta se evaluó mediante el Índice de Calidad de la Dieta Revisado (IQD-R por sus siglas en portugués) y los costes directos de la alimentación se estimaron mediante precios de mercado. No se observaron diferencias significativas en el coste directo de la alimentación o características de los individuos entre los terciles de adhesión. Cuando se analizaron todos los recordatorios no hubo correlación entre coste y calidad de la dieta (r = 0,38; p = 0,17), ya en el análisis por terciles hubo una débil correlación entre el menor tercil de adhesión (r = -0,112; p = 0,03). El presente estudio apuntó una ausencia de diferencias entre los costes directos de la alimentación clasificada como saludable y aquella con peor calidad nutricional, lo que puede ser un incentivo para la adhesión a las orientaciones alimentarias en Brasil, minimizando barreras para la adopción de estilos de vida saludables.

Valve heart surgery in Brazil - the bypass registry analysis

Abstract Objective: To analyze the profile and outcomes of patients who underwent valve heart surgery in Brazil, using information retrieved from the Brazilian Registry of Cardiovascular Surgeries in Adults (BYPASS Registry) database. Methods: This is a multicenter cohort study, evaluating 920 patients submitted to heart valve surgery. Demographics and postoperative clinical outcomes were assessed and compared to estimate mortality risk using the European System for Cardiac Operative Risk Evaluation (EuroSCORE). Results: Isolated aortic valve replacement was the most frequently performed surgery (34%), followed by isolated mitral valve replacement (24.9%). Valve repair was performed in 21% of mitral procedures. Minimally invasive access was performed in 1.6% and the most frequent postoperative complications were arrhythmias (22.6%), infections (5.7%), and low-output syndrome (5.1%). Operations covered by the public health system accounted for 80.8% and the hospital mortality rate was 7.3%. Conclusion: The most frequent isolated valve surgery in Brazil is the aortic valve replacement by conventional open access and the rheumatic disease is still the main etiology for valve surgery. The BYPASS Registry has a fundamental role to provide information on the profile of patients with valve heart disease in our country in order to delineate adequate strategies for health promotion and resource allocation for cardiac surgery.