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Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF)
BACKGROUND: Ischemic cardiomyopathy and severe left ventricular dysfunction are well established to represent the main determinants of poor survival and premature death compared with preserved ventricular function. However, the role of myocardial revascularization as a therapeutic alternative is not...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7164251/ https://www.ncbi.nlm.nih.gov/pubmed/32299458 http://dx.doi.org/10.1186/s13063-020-04270-w |
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author | Rezende, Paulo Cury Hueb, Whady Bocchi, Edimar Alcides Farkouh, Michael Junior, Carlos Vicente Serrano Lima, Eduardo Gomes Silva, Expedito Eustáquio Ribeiro Dallan, Luis Alberto Oliveira Gaiotto, Fabio Antonio Garzillo, Cibele Larrosa Rochitte, Carlos Eduardo Nomura, Cesar Higa Scudeler, Thiago Luis Soares, Paulo Rogério Jatene, Fabio Biscegli Ramires, José Antonio Franchini Filho, Roberto Kalil |
author_facet | Rezende, Paulo Cury Hueb, Whady Bocchi, Edimar Alcides Farkouh, Michael Junior, Carlos Vicente Serrano Lima, Eduardo Gomes Silva, Expedito Eustáquio Ribeiro Dallan, Luis Alberto Oliveira Gaiotto, Fabio Antonio Garzillo, Cibele Larrosa Rochitte, Carlos Eduardo Nomura, Cesar Higa Scudeler, Thiago Luis Soares, Paulo Rogério Jatene, Fabio Biscegli Ramires, José Antonio Franchini Filho, Roberto Kalil |
author_sort | Rezende, Paulo Cury |
collection | PubMed |
description | BACKGROUND: Ischemic cardiomyopathy and severe left ventricular dysfunction are well established to represent the main determinants of poor survival and premature death compared with preserved ventricular function. However, the role of myocardial revascularization as a therapeutic alternative is not known to improve the long-term prognosis in this group of patients. This study will investigate whether myocardial revascularization contributes to a better prognosis for patients compared with those treated with drugs alone and followed over the long term. METHODS: The study will include 600 patients with coronary artery disease associated with ischemic cardiomyopathy. The surgical or drug therapy option will be randomized, and the events considered for analysis will be all-cause mortality, nonfatal infarction, unstable angina requiring additional revascularization, and stroke. The events will be analyzed according to the intent-to-treat principle. Patients with multivessel coronary disease and left ventricular ejection fraction measurements of less than 35% will be included. In addition, myocardial ischemia will be documented by myocardial scintigraphy. Markers of myocardial necrosis will be checked at admission and after the procedure. DISCUSSION: The role of myocardial revascularization (CABG) in the treatment of patients with coronary artery disease and heart failure is not clearly established. The surgical option of revascularizing the myocardium is a procedure designed to reduce the load of myocardial hibernation in patients with heart failure caused by coronary artery disease. On the other hand, the assessment of myocardial viability is frequently used to identify patients with left ventricular ischemic dysfunction in which CABG may add survival benefit. However, the effectiveness of this option is uncertain. The great difficulty in establishing the efficacy of surgical intervention is based on the understanding of viability without ischemia. Thus, this study will include only patients with viable and truly ischemic myocardium to correct this anomaly. TRIAL REGISTRATION: Evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy submitted to medical or surgical treatment: MASS-VI (HF), ISRCTN77449548, Oct 10th, 2019 (retrospectively registered). |
format | Online Article Text |
id | pubmed-7164251 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-71642512020-04-22 Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF) Rezende, Paulo Cury Hueb, Whady Bocchi, Edimar Alcides Farkouh, Michael Junior, Carlos Vicente Serrano Lima, Eduardo Gomes Silva, Expedito Eustáquio Ribeiro Dallan, Luis Alberto Oliveira Gaiotto, Fabio Antonio Garzillo, Cibele Larrosa Rochitte, Carlos Eduardo Nomura, Cesar Higa Scudeler, Thiago Luis Soares, Paulo Rogério Jatene, Fabio Biscegli Ramires, José Antonio Franchini Filho, Roberto Kalil Trials Study Protocol BACKGROUND: Ischemic cardiomyopathy and severe left ventricular dysfunction are well established to represent the main determinants of poor survival and premature death compared with preserved ventricular function. However, the role of myocardial revascularization as a therapeutic alternative is not known to improve the long-term prognosis in this group of patients. This study will investigate whether myocardial revascularization contributes to a better prognosis for patients compared with those treated with drugs alone and followed over the long term. METHODS: The study will include 600 patients with coronary artery disease associated with ischemic cardiomyopathy. The surgical or drug therapy option will be randomized, and the events considered for analysis will be all-cause mortality, nonfatal infarction, unstable angina requiring additional revascularization, and stroke. The events will be analyzed according to the intent-to-treat principle. Patients with multivessel coronary disease and left ventricular ejection fraction measurements of less than 35% will be included. In addition, myocardial ischemia will be documented by myocardial scintigraphy. Markers of myocardial necrosis will be checked at admission and after the procedure. DISCUSSION: The role of myocardial revascularization (CABG) in the treatment of patients with coronary artery disease and heart failure is not clearly established. The surgical option of revascularizing the myocardium is a procedure designed to reduce the load of myocardial hibernation in patients with heart failure caused by coronary artery disease. On the other hand, the assessment of myocardial viability is frequently used to identify patients with left ventricular ischemic dysfunction in which CABG may add survival benefit. However, the effectiveness of this option is uncertain. The great difficulty in establishing the efficacy of surgical intervention is based on the understanding of viability without ischemia. Thus, this study will include only patients with viable and truly ischemic myocardium to correct this anomaly. TRIAL REGISTRATION: Evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy submitted to medical or surgical treatment: MASS-VI (HF), ISRCTN77449548, Oct 10th, 2019 (retrospectively registered). BioMed Central 2020-04-16 /pmc/articles/PMC7164251/ /pubmed/32299458 http://dx.doi.org/10.1186/s13063-020-04270-w Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Rezende, Paulo Cury Hueb, Whady Bocchi, Edimar Alcides Farkouh, Michael Junior, Carlos Vicente Serrano Lima, Eduardo Gomes Silva, Expedito Eustáquio Ribeiro Dallan, Luis Alberto Oliveira Gaiotto, Fabio Antonio Garzillo, Cibele Larrosa Rochitte, Carlos Eduardo Nomura, Cesar Higa Scudeler, Thiago Luis Soares, Paulo Rogério Jatene, Fabio Biscegli Ramires, José Antonio Franchini Filho, Roberto Kalil Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF) |
title | Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF) |
title_full | Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF) |
title_fullStr | Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF) |
title_full_unstemmed | Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF) |
title_short | Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF) |
title_sort | hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: mass-vi (hf) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7164251/ https://www.ncbi.nlm.nih.gov/pubmed/32299458 http://dx.doi.org/10.1186/s13063-020-04270-w |
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