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)

Autor: Expedito Eustáquio Ribeiro da Silva, Edimar Alcides Bocchi, Fábio Antônio Gaiotto, Whady Hueb, Michael E. Farkouh, José Antonio Franchini Ramires, Luís Alberto Oliveira Dallan, Cesar Higa Nomura, Roberto Kalil Filho, Paulo Cury Rezende, Thiago Luis Scudeler, Fabio Biscegli Jatene, Eduardo Gomes Lima, Carlos E. Rochitte, Cibele Larrosa Garzillo, Paulo R. Soares, Carlos Vicente Serrano Junior
Jazyk: angličtina
Rok vydání: 2020
Předmět:
medicine.medical_specialty
medicine.medical_treatment
Cost-Benefit Analysis
Adrenergic beta-Antagonists
Ischemia
Myocardial Ischemia
Medicine (miscellaneous)
Angiotensin-Converting Enzyme Inhibitors
Coronary Artery Disease
030204 cardiovascular system & hematology
Revascularization
Coronary artery disease
03 medical and health sciences
Study Protocol
Angiotensin Receptor Antagonists
Ventricular Dysfunction
Left
0302 clinical medicine
Internal medicine
medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
cardiovascular diseases
Prospective Studies
Coronary Artery Bypass
Diuretics
Stroke
Ischemic cardiomyopathy
Ventricular dysfunction
Coronary artery disease
CABG
Randomized controlled trial
Randomized Controlled Trials as Topic
Heart Failure
lcsh:R5-920
Ischemic cardiomyopathy
Ejection fraction
Unstable angina
business.industry
Stroke Volume
medicine.disease
Prognosis
Treatment Outcome
Heart failure
Cardiology
business
lcsh:Medicine (General)
Follow-Up Studies
Zdroj: Trials
Trials, Vol 21, Iss 1, Pp 1-7 (2020)
ISSN: 1745-6215
Popis: 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).
Databáze: OpenAIRE
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