PATRICIA OLIVEIRA GUIMARAES
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- Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection(2017) GUIMARES, Patricia O.; LOPES, Renato D.; STEVENS, Susanna R.; ZIMERMAN, Andre; WRUCK, Lisa; JAMES, Stefan K.; HAQUE, Ghazala; GIRALDEZ, Roberto Rocha C. V.; ALEXANDER, John H.; ALEXANDER, Karen P.Background-End points and adverse events (AEs) are collected separately in clinical trials, yet regulatory requirements for serious AE reporting vary across regions, so classifying end points according to seriousness criteria can be useful in global trials. Methods and Results-In the Apixaban for Prevention of Acute Ischemic Events 2 (APPRAISE-2) trial, patients with a recent acute coronary syndrome were randomized to apixaban or placebo for the prevention of recurrent ischemic events. Suspected end points (myocardial infarction, stroke, or bleeding) were adjudicated by an independent clinical events classification committee. Safety criteria were collected for suspected end points and AEs. Patient-level event rates per 100 patient-days of follow-up, modeled using Poisson regression, explored the influence of region and patient characteristics on event reporting. Overall, 13 909 events were reported by 858 sites in 39 countries; 8.4% (n=1166) were suspected end points, and 91.6% (n=12 743) were AEs. Overall, 66.0% of suspected end points were confirmed by the clinical events classification committee. Most clinical events classification committee-confirmed end points met criteria to be classified as serious (94.0%); many clinical events classification committee-negated end points also did (63.2%), but fewer AEs met seriousness criteria (17.9%). The most common seriousness criterion was hospitalization (79.9%, n=2594). Region explained 28.7% of end point-and 26.4% of serious AE-reporting variation, and patient characteristics explained an additional 25.4% of end point and 13.4% of serious AE variation. Nonserious AE-reporting variation was not explained by adjustment. Conclusions-An integrated collection of end points and serious AEs is feasible in a multinational trial and illustrates the shared characteristics of events. Tailoring event collection to fit the phase and purpose of the trial is achievable and informative.
- High risk coronavirus disease 2019: The primary results of the CoronaHeart multi-center cohort study(2021) GUIMARAES, Patricia O.; SOUZA, Francis R. de; LOPES, Renato D.; BITTAR, Cristina; CARDOZO, Francisco A.; CARAMELLI, Bruno; CALDERARO, Daniela; ALBUQUERQUE, Cicero P.; DRAGER, Luciano F.; FERES, Fausto; BARACIOLI, Luciano; FILHO, Gilson Feitosa; BARBOSA, Roberto R.; RIBEIRO, Henrique B.; RIBEIRO, Expedito; ALVES, Renato J.; SOEIRO, Alexandre; FAILLACE, Bruno; FIGUEIREDO, Estevao; DAMIANI, Lucas P.; VAL, Renata M. do; HUEMER, Natassja; NICOLAI, Lisie G.; HAJJAR, Ludhmila A.; ABIZAID, Alexandre; FILHO, Roberto KalilBackground: Patients with Coronavirus Disease 2019 (COVID-19) may present high risk features during hospitalization, including cardiovascular manifestations. However, less is known about the factors that may further increase the risk of death in these patients. Methods: We included patients with COVID-19 and high risk features according to clinical and/or labo-ratory criteria at 21 sites in Brazil from June 10th to October 23rd of 2020. All variables were collected until hospital discharge or in-hospital death. Results: A total of 2546 participants were included (mean age 65 years; 60.3% male). Overall, 70.8% were admitted to intensive care units and 54.2% had elevated troponin levels. In-hospital mortality was 41.7%. An interaction among sex, age and mortality was found (p = 0.007). Younger women presented higher rates of death than men (30.0% vs 22.9%), while older men presented higher rates of death than women (57.6% vs 49.2%). The strongest factors associated with in-hospital mortality were need for mechanical ventilation (odds ratio [OR] 8.2, 95% confidence interval [CI] 5.4-12.7), elevated C-reactive protein (OR 2.3, 95% CI 1.7-2.9), cancer (OR 1.8, 95 %CI 1.2-2.9), and elevated troponin levels (OR 1.8, 95% CI 1.4-2.3). A risk score was developed for risk assessment of in-hospital mortality. Conclusions: This cohort showed that patients with COVID-19 and high risk features have an elevated rate of in-hospital mortality with differences according to age and sex. These results highlight unique aspects of this population and might help identifying patients who may benefit from more careful initial surveil-lance and potential subsequent interventional therapies. (c) 2021 Published by Elsevier B.V.
- Diagnostic Performance of Coronary Tomography Angiography and Serial Measurements of Sensitive Cardiac Troponin in Patients With Chest Pain and Intermediate Risk for Cardiovascular Events(2022) SOEIRO, Alexandre de Matos; BISELLI, Bruno; LEAL, Tatiana C. A. T.; BOSSA, Aline Siqueira; CESAR, Maria Cristina; JALLAD, Sergio; GOLDSTEIN, Priscila Gherardi; GUIMARAES, Patricia Oliveira; JR, Carlos Vicente Serrano; NOMURA, Cesar Higa; NAKAMURA, Debora; ROCHITTE, Carlos Eduardo; SOARES, Paulo Rogerio; JR, Mucio Tavares de OliveiraBackground: Coronary tomography angiography (CTA) has been mainly used for chest pain evaluation in low-risk patients, and few data exist regarding patients at intermediate risk. Objective: To evaluate the performance of serial measures of sensitive troponin and CTA in intermediate-risk patients. Methods: A total of 100 patients with chest pain, TIMI risk scores of 3 or 4, and negative troponin were prospectively included. All patients underwent CTA and those with coronary stenosis >= 50% were referred to invasive coronary angiography. Patients with coronary lesions <50% were discharged and contacted 30 days later by a telephone call to assess clinical outcomes. Outcomes were hospitalization, death, and myocardial infarction at 30 days. The comparison between methods was performed by Kappa agreement test. The performance of troponin measures and CTA for detecting significant coronary lesions and clinical outcomes was calculated. Results were considered statistically significant when p < 0.05. Results: Coronary stenosis >= 50% on CTA was found in 38% of patients and significant coronary lesions on coronary angiography were found in 31 patients. Two clinical events were observed. Kappa agreement analysis showed low agreement between troponin measures and CTA in the detection of significant coronary lesions (kappa = 0.022, p = 0.78). The performance of CTA for detecting significant coronary lesions on coronary angiography or for predicting clinical events at 30 days was better than sensitive troponin measures (accuracy of 91% versus 60%). Conclusion: CTA performed better than sensitive troponin measures in the detection of significant coronary disease in patients with chest pain and intermediate risk for cardiovascular events.
- The association of myocardial strain with cardiac magnetic resonance and clinical outcomes in patients with acute myocarditis(2023) SOEIRO, Alexandre M.; BOSSA, Aline S.; CESAR, Maria C.; LEAL, Tatiana C. A. T.; GARCIA, Guilherme; FONSECA, Rafael A.; NAKAMURA, Debora; GUIMARAES, Patricia O.; SOEIRO, Maria C. F. A.; JR, Carlos V. Serrano; SOARES, Paulo R.; MUELLER, Christian; MEBAZAA, Alexandre; FERNANDES, Fabio; NOMURA, Cesar H.; ROCHITTE, Carlos E.; JR, Mucio T. de OliveiraIntroductionThe role of myocardial strain in risk prediction for acute myocarditis (AMC) patients, measured by cardiac magnetic resonance (CMR), deserves further investigation. Our objective was to evaluate the association between myocardial strain measured by CMR and clinical events in AMC patients. Material and methodsThis was a prospective single-center study of patients with AMC. We included 100 patients with AMC with CMR confirmation. The primary outcome was the composite of all-cause mortality, heart failure and AMC recurrence in 24 months. A subgroup analysis was performed on a sample of 36 patients who underwent a second CMR between 6 and 18 months. The association between strain measures and clinical events or an increase in left ventricular ejection fraction (LVEF) was explored using Cox regression analysis. Global peak radial, circumferential and longitudinal strain in the left and right ventricles was assessed. ROC curve analysis was performed to identify cutoff points for clinical event prediction. ResultsThe mean follow-up was 18.7 & PLUSMN; 2.3 months, and the composite primary outcome occurred in 26 patients. The median LVEF at CMR at baseline was 57.5% (14.6%). LV radial strain (HR = 0.918, 95% CI: 0.858-0.982, p = 0.012), LV circumferential strain (HR = 1.177, 95% CI: 1.046-1.325, p = 0.007) and LV longitudinal strain (HR = 1.173, 95% CI: 1.031-1.334, p = 0.015) were independently associated with clinical event occurrence. The areas under the ROC curve for clinical event prediction were 0.80, 0.79 and 0.80 for LV radial, circumferential, and longitudinal strain, respectively. LV longitudinal strain was independently correlated with prognosis (HR = 1.282, CI 95%: 1.022-1.524, p = 0.007), even when analyzed together with ejection fraction and delayed enhancement. LV and right ventricle (RV) strain were not associated with an increase in LVEF. Finally, when the initial CMR findings were compared with the follow-up CMR findings, improvements in the measures of LV and RV myocardial strain were observed. ConclusionMeasurement of myocardial strain by CMR can provide prognostic information on AMC patients. LV radial, circumferential and longitudinal strain were associated with long-term clinical events in these patients.
- Cancer and Cardiovascular Diseases during the COVID-19 Pandemic(2020) KAWAHARA, Lucas Tokio; COSTA, Isabela Bispo Santos da Silva; BARROS, Cecilia Chie Sakaguchi; ALMEIDA, Gabriel Coelho de; BITTAR, Cristina Salvadori; RIZK, Stephanie Itala; TESTA, Laura; MONIZ, Camila Motta Venchiarutti; PEREIRA, Juliana; OLIVEIRA, Glaucia Maria Moraes de; DIZ, Maria Del Pilar Estevez; GUIMARAES, Patricia Oliveira; PINTO, Ibraim Masciarelli; KALIL FILHO, Roberto; HAJJAR, Ludhmila Abrahao; HOFF, Paulo M.The challenges that the COVID-19 pandemic cretead to the healthcare system have made it necessary to adapt routines and services, with the objectives of controlling the spread of the virus and preserving health. Safe and correct management of patients in risks groups, such as elderly patients, patients with cardiovascular diseases, and patients with cancer, has become even more important. Thus, cardio-oncology has gained a new dimension, with the aim of adapting to patients' needs during the pandemic by restructuring the system of care in a manner that offers quality and safety in healthcare.