Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction – MiHeart/AMI study

Background: Myocardial infarction remains as a major cause of mortality worldwide and a high rate of survivors develop heart failure as a sequel, resulting in a high morbidity and elevated expenditures for health system resources. We have designed a multicenter trial to test for the efficacy of autologous bone marrow (ABM) mononuclear cell (MC) transplantation in this subgroup of patients. The main hypothesis to be tested is that treated patients will have a significantly higher ejection fraction (EF) improvement after 6 months than controls. Methods: A sample of 300 patients admitted with ST elevation acute myocardial infarction (STEMI) and left ventricle (LV) systolic dysfunction, and submitted to successful mechanical or chemical recanalization of the infarct-related coronary artery will be selected for inclusion and randomized to either treated or control group in a double blind manner. The former group will receive 100 x 106 MC suspended in saline with 5% autologous serum in the culprit vessel, while the latter will receive placebo (saline with 5% autologous serum). Implications: Many phase I/II clinical trials using cell therapy for STEMI have been reported, demonstrating that cell transplantation is safe and may lead to better preserved LV function. Patients with high risk to develop systolic dysfunction have the potential to benefit more. Larger randomized, double blind and controlled trials to test for the efficacy of cell therapies in patients with high risk for developing heart failure are required.Brazilian Ministry of Science and Technology (MCT)/The Financing Agency for Studies and Projects (FINEP

Fulfillment of the Brazilian Agenda of Priorities in Health Research

This commentary describes how the Brazilian Ministry of Health's (MoH) research support policy fulfilled the National Agenda of Priorities in Health Research (NAPHR). In 2003, the MoH started a democratic process in order to establish a priority agenda in health research involving investigators, health managers and community leaders. The Agenda was launched in 2004 and is guiding budget allocations in an attempt to reduce the gap between scientific knowledge and health practice and activities, aiming to contribute to improving Brazilian quality of life. Many strategies were developed, for instance: Cooperation Agreements between the Ministry of Health and the Ministry of Science and Technology; the decentralization of research support at state levels with the participation of local Health Secretariats and Science and Technology Institutions; Health Technology Assessment; innovation in neglected diseases; research networks and multicenter studies in adult, women's and children's health; cardiovascular risk in adolescents; clinical research and stem cell therapy. The budget allocated by the Ministry of Health and partners was expressive: US$419 million to support almost 3,600 projects. The three sub-agenda with the higher proportion of resources were "industrial health complex", "clinical research" and "communicable diseases", which are considered strategic for innovation and national development. The Southeast region conducted 40.5% of all projects and detained 59.7% of the resources, attributable to the concentration of the most traditional health research institutes and universities in the states of São Paulo and Rio de Janeiro. The second most granted region was the Northeast, which reflects the result of a governmental policy to integrate and modernize this densely populated area and the poorest region in the country. Although Brazil began the design and implementation of the NAPHR in 2003, it has done so in accordance with the 'good practice principles' recently published: inclusive process, information gathering, careful planning and funding policy, transparency and internal evaluation (an external independent evaluation is underway). The effort in guiding the health research policy has achieved and legitimated an unprecedented developmental spurt to support strategic health research. We believe this experience is valuable and applicable to other countries, but different settings and local political circumstances will determine the best course of action to follow

Patient and physician preferences for attributes of coronary revascularization

Carlos Alberto da Silva Magliano,1 Andrea Liborio Monteiro,2 Bernardo Rangel Tura,1 Claudia Silvia Rocha Oliveira,1 Amanda Rebeca de Oliveira Rebelo,1 Claudia Cristina de Aguiar Pereira3 1HTA Department, National Institute of Cardiology, Rio de Janeiro, Brazil; 2Department of Pharmacy Systems, Outcomes and Policy, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA; 3The National School of Public Health Sergio Arouca ENSP/Fiocruz, Rio de Janeiro, Brazil Background: Patients with a diagnosis of coronary artery disease (CAD) may face important decisions regarding treatment options, with the “right choice” depending on the relative weights of risks and benefits. Studies performed as discrete choice experiments are used to estimate these weights, and attribute selection is an essential step in the design of these studies. Attributes not included in the design cannot be analyzed. In this study, we aimed to elicit, rank, and rate attributes that may be considered important to patients and physicians who must choose between angioplasty and surgery for coronary revascularization. Methods: The elicitation process involved performing a systematic review to search for attributes cited in declared preference studies in addition to face-to-face interviews with cardiologists and experts. The interviews were audio-recorded in digital format, and the collected data were transcribed and searched to identify new attributes. The criterion used to finish the data collection process was sampling saturation. Results: A systematic review resulted in the selection of the following 14 attributes: atrial fibrillation, heart failure, incision scar, length of stay, long-term survival, myocardial infarction, periprocedural death, postoperative infection, postprocedural angina, pseudoaneurysm, renal failure, repeat coronary artery bypass grafting, repeat percutaneous coronary intervention, and stroke. The interviews added no new attributes. After rating, we identified significant differences in the values that patients and cardiologists placed on renal insufficiency (p<0.001), periprocedural death (p<0.001), and long-term survival (p<0.001). Conclusion: Decisions regarding the best treatment option for patients with CAD should be made based on differences in risk and the patient’s preference regarding the most relevant endpoints. We elicited, ranked, and rated 14 attributes related to CAD treatment options. This list of attributes may help researchers who seek to perform future preference studies of CAD treatment options. Keywords: preference, ranking, rating, coronary, angin

Feasibility of visual aids for risk evaluation by hospitalized patients with coronary artery disease: results from face-to-face interviews

Carlos Alberto da Silva Magliano,1 Andrea Liborio Monteiro,2 Bernardo Rangel Tura,1 Claudia Silvia Rocha Oliveira,1 Amanda Rebeca de Oliveira Rebelo,1 Claudia Cristina de Aguiar Pereira3 1NATS, Instituto Nacional de Cardiologia, INC, Rio de Janeiro, Rio de Janeiro, Brazil; 2Department of Pharmacy Systems, Outcomes and Policy, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA; 3Escola Nacional de Saúde Pública, ENSP, FIOCRUZ, Rio de Janeiro, Brazil Purpose: Communicating information about risk and probability to patients is considered a difficult task. In this study, we aim to evaluate the use of visual aids representing perioperative mortality and long-term survival in the communication process for patients diagnosed with coronary artery disease at the National Institute of Cardiology, a Brazilian public hospital specializing in cardiology. Patients and methods: One-on-one interviews were conducted between August 1 and November 20, 2017. Patients were asked to imagine that their doctor was seeking their input in the decision regarding which treatment represented the best option for them. Patients were required to choose between alternatives by considering only the different benefits and risks shown in each scenario, described as the proportion of patients who had died during the perioperative period and within 5 years. Each participant evaluated the same eight scenarios. We evaluated their answers in a qualitative and quantitative analysis. Results: The main findings were that all patients verbally expressed concern about perioperative mortality and that 25% did not express concern about long-term mortality. Twelve percent considered the probabilities irrelevant on the grounds that their prognosis would depend on “God’s will.” Ten percent of the patients disregarded the reported likelihood of perioperative mortality, deciding to focus solely on the “chance of being cured.” In the quantitative analysis, the vast majority of respondents chose the “correct” alternatives, meaning that they made consistent and rational choices. Conclusion: The use of visual aids to present risk attributes appeared feasible in our sample. The impact of heuristics and religious beliefs on shared health decision making needs to be explored better in future studies. Keywords: patients’ preferences, coronary revascularization, angina, cardiology, coronary artery bypass grafting, percutaneous coronary interventio