A short description, 5000 characters Ischemic cardiomyopathy related to coronary artery disease is currently the leading cause of heart failure. When it is responsible for heart failure, the coronary artery disease likely involves 2 or 3 vessels. Percutaneous coronary angioplasty, which is the other available technique for coronary revascularization, has never been evaluated in this indication. The results of retrospective registries studying the strategy for multivessel revascularization in patients with heart failure are inconsistent and no randomized study has been performed so far. Currently, ESC guidelines recommends to perform coronary-artery bypass grafting (IB) or percutaneous coronary intervention (IIa C) with the acknowledgement that percutaneous coronary intervention has never been properly evaluated in this setting. However, it has been previously demonstrated that left ventricle dysfunction significantly increases mortality and morbidity during and after cardiac surgery (3-10% mortality when LVEF is ≤30%). Moreover, the technical progresses in stent development and manufacturing have led to a dramatic decrease in the incidence of stent thrombosis and in-stent restenosis. Therefore, we hypothesize that percutaneous coronary angioplasty may be an attractive strategy for revascularization in patients with multi-vessel disease and left ventricle dysfunction, who are at high risk of surgical complication. Thus, we aim to test the hypothesis that percutaneous coronary intervention is non-inferior to coronary-artery bypass grafting for revascularization in patients with multivessel disease and left ventricle dysfunction.
The main objective is to demonstrate that percutaneous coronary angioplasty is non-inferior to coronary-artery bypass grafting for multivessel revascularization in patients with left ventricular dysfunction on major cardiac and cerebrovascular events (MACCE).
Method:A Prospective Randomized Open label, Blinded Endpoint, parallel-group, active controlled, non-inferiority, multicenter trial.
Age ≥18 years
Left ventricle ejection fraction ≤35% measured by echocardiography, cardiac magnetic resonance imaging ventriculogram or gated Single Photon Emission Computed Tomography ventriculogram
Three vessel disease
Two vessel disease involving left main or proximal left anterior descending artery
PCI of any coronary artery lesions within 6 months prior to randomization
CABG at any time prior to randomization
Ongoing cardiogenic shock at the time of coronary angiogram (SBP< 90 mmHg with clinical signs of low output or patients requiring inotropic agents)
Contra indication for PCI or CABG determined by the heart team
Parallel
Percutaneous coronary intervention
Procedure/SurgeryThe studied intervention will be percutaneous coronary angioplasty with drug eluting stent implantation. Percutaneous coronary intervention may be performed during one single procedure or during staged procedures. The decision will be left at the investigator choice. PCI will be performed using drug eluting stent exclusively. The techniques for bifurcation lesions and chronic total occlusion angioplasty will be left at the operator choice. The choice of the drug eluting stent used will be left at the operator's choice. Anti-platelet therapy will be given to all patients randomized to PCI. The choice of the anti-thrombotic regiment and its duration will be left at the investigator choice (after assessment of initial presentation, bleeding and ischemic risks) but will have to comply with the European Society of Cardiology guidelines.
Coronary artery bypass grafting
Procedure/SurgeryCoronary artery bypass grafting technique will be total arterial revascularization unless internal mammary grafts are unavailable or have inadequate flow. All patients will be treated with anti-thrombotic therapy according to the European Society of Cardiology guidelines
MACE
Comparison of MACE between PCI and CABG. Major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
MACE
Comparison of MACE between PCI and CABG.major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
MACE
Comparison of MACE between PCI and CABG. Major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
MACE
major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
Death
Death from any cause at the end of follow-up
Stroke
Stroke at the end of follow-up
Myocardial Infarction
Myocardial Infarction at the end of follow-up
Unplanned hospitalization
Unplanned hospitalization at the end of follow-up
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