Hypotheses, rationale, design, and methods for prognostic evaluation of cardiac biomarker elevation after percutaneous and surgical revascularization in the absence of manifest myocardial infarction. A comparative analysis of biomarkers and cardiac magnetic resonance. The MASS-V Trial.
BACKGROUND
Although the release of cardiac biomarkers after percutaneous (PCI) or surgical revascularization (CABG) is common, its prognostic significance is not known. Questions remain about the mechanisms and degree of correlation between the release, the volume of myocardial tissue loss, and the long-term significance. Delayed-enhancement of cardiac magnetic resonance (CMR) consistently quantifies areas of irreversible myocardial injury. To investigate the quantitative relationship between irreversible injury and cardiac biomarkers, we will evaluate the extent of irreversible injury in patients undergoing PCI and CABG and relate it to postprocedural modifications in cardiac biomarkers and long-term prognosis.


METHODS
The study will include 150 patients with multivessel coronary artery disease (CAD) with left ventricle ejection fraction (LVEF) and a formal indication for CABG; 50 patients will undergo CABG with cardiopulmonary bypass (CPB); 50 patients with the same arterial and ventricular condition indicated for myocardial revascularization will undergo CABG without CPB; and another 50 patients with CAD and preserved ventricular function will undergo PCI using stents. All patients will undergo CMR before and after surgery or PCI. We will also evaluate the release of cardiac markers of necrosis immediately before and after each procedure. Primary outcome considered is overall death in a 5-year follow-up. Secondary outcomes are levels of CK-MB isoenzyme and I-Troponin in association with presence of myocardial fibrosis and systolic left ventricle dysfunction assessed by CMR.


CONCLUSIONS
The MASS-V Trial aims to establish reliable values for parameters of enzyme markers of myocardial necrosis in the absence of manifest myocardial infarction after mechanical interventions. The establishments of these indices have diagnostic value and clinical prognosis and therefore require relevant and different therapeutic measures. In daily practice, the inappropriate use of these necrosis markers has led to misdiagnosis and therefore wrong treatment. The appearance of a more sensitive tool such as CMR provides an unprecedented diagnostic accuracy of myocardial damage when correlated with necrosis enzyme markers. We aim to correlate laboratory data with imaging, thereby establishing more refined data on the presence or absence of irreversible myocardial injury after the procedure, either percutaneous or surgical, and this, with or without the use of cardiopulmonary bypass.
Heart Institute of the University of São Paulo, São Paulo, Brazil. whady.hueb@incor.usp.br
Whady
W
Hueb
Bernard J
BJ
Gersh
Paulo Cury
PC
Rezende
Cibele Larrosa
CL
Garzillo
Eduardo Gomes
EG
Lima
Ricardo D'Oliveira
RD
Vieira
Rosa Maria Rahmi
RM
Garcia
Desiderio
D
Favarato
Carlos Alexandre W
CA
Segre
Alexandre Costa
AC
Pereira
Paulo Rogério
PR
Soares
Expedito
E
Ribeiro
Pedro
P
Lemos
Marco A
MA
Perin
Célia Cassaro
CC
Strunz
Luis A O
LA
Dallan
Fabio B
FB
Jatene
Noedir A G
NA
Stolf
Alexandre Ciappina
AC
Hueb
Ricardo
R
Dias
Fabio A
FA
Gaiotto
Leandro Menezes Alves
LM
da Costa
Fernando Teiichi Costa
FT
Oikawa
Rodrigo Morel Vieira
RM
de Melo
Carlos Vicente
CV
Serrano
Luiz Francisco Rodrigues
LF
de Ávila
Alexandre Volney
AV
Villa
José Rodrigues Parga
JR
Filho
César
C
Nomura
José A F
JA
Ramires
Roberto
R
Kalil Filho
D015415:Biomarkers / Q000097:blood; D016009:Chi-Square Distribution; D001026:Coronary Artery Bypass / Q000009:adverse effects*; D047549:Coronary Artery Bypass, Off-Pump / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000097:blood / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D052279:Creatine Kinase, MB Form / Q000097:blood*; D005355:Fibrosis; D006331:Heart Diseases / Q000097:blood / Q000175:diagnosis* / Q000473:pathology / Q000503:physiopathology; D006801:Humans; D016015:Logistic Models; D019028:Magnetic Resonance Imaging, Cine; D015999:Multivariate Analysis; D009206:Myocardium / Q000378:metabolism / Q000473:pathology; D009336:Necrosis; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000295:instrumentation; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012107:Research Design; D015607:Stents; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D019210:Troponin I / Q000097:blood*; D015854:Up-Regulation; D018487:Ventricular Dysfunction, Left / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology; D016277:Ventricular Function, Left
D015415:Biomarkers; D019210:Troponin I; D052279:Creatine Kinase, MB Form