Hypotheses, rationale, design and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy submitted to medical or surgical treatment: MASS-VI (HF)

• Grant number: 21/11407-0
• Support Opportunities: Regular Research Grants
• Duration: July 01, 2022 - June 30, 2024
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Whady Armindo Hueb
• Grantee: Whady Armindo Hueb
• Host Institution: Instituto do Coração Professor Euryclides de Jesus Zerbini (INCOR). Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Associated researchers: Carlos Alexandre Wainrober Segre ; Carlos Eduardo Rochitte ; Carlos Vicente Serrano Junior ; Cibele Larrosa Garzillo ; Edimar Alcides Bocchi ; Eduardo Gomes Lima ; Guilherme Fernandes de Carvalho ; Gustavo André Boeing Boros ; Jairo Tavares Nunes ; Matheus de Oliveira Laterza Ribeiro ; Mauricio Rigodanzo Mocha ; Paulo Cury Rezende ; Paulo Rogério Soares ; Thiago Luis Scudeler

Abstract

Compared with preserved left ventricular function, patients with ischemic cardiomyopathy and severe ventricular dysfunction represent one of the main determinants of a worse survival prognosis and premature death. On the other hand, it is not known whether myocardial revascularization can improve the long-term prognosis in this group of patients. Objectives: To compare whether revascularization contributes to a better long-term prognosis compared to clinical treatment. Methods: 600 patients with coronary artery disease (CAD) associated with ischemic cardiomyopathy and ejection fraction d 35% will be included. Both surgery and medical treatment will have a randomized option and events will be considered as intention-to-treat: death from any cause, non-fatal infarction, additional revascularization and stroke. Myocardial ischemia will be documented, and myocardial necrosis markers will be known at admission and after the procedure. Discussion: The surgical option to vascularize dysfunctional myocardium is intended to reduce the burden of myocardial hibernation in patients with heart failure caused by infarction sequelae. Additionally, the assessment of myocardial viability with or without ischemia is an ongoing challenge. Feasibility tests are often used without identifying ischemia, aiming at benefits in terms of survival. Thus, myocardial viability without ischemia can add difficulties in understanding myocardial recovery. Our study will focus on viability with ischemia. (AU)