Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction (RESTORE-PCI)
Heart Failure With Reduced Ejection Fraction, Ischemic Cardiomyopathy
About this trial
This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring ischemic cardiomyopathy, percutaneous coronary intervention, ejection fraction, guideline-directed medical treatment
Eligibility Criteria
Inclusion Criteria: Subject must be at least 19 years of age Patients with stage C heart failure and left ventricular ejection fraction<40% Patients with significant coronary artery stenosis (diameter stenosis>50% with proven inducible myocardial ischemia by invasive physiologic assessment) Coronary artery disease is amenable for percutaneous coronary intervention (PCI) Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Exclusion Criteria: Myocardial infarction by universal definition within 4 weeks of randomization Non-viable myocardium in myocardial viability test (cardiac magnetic resonance, dobutamine-stress echocardiography, delayed single-photon emission computerized tomography, or aneurysmal change in echocardiography) Target lesions not amenable for PCI by operators' decision Patients who need left ventricular assisted device (LVAD) or heart transplantation at the time of randomization Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) Pregnancy or breast feeding Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment) Unwillingness or inability to comply with the procedures described in this protocol.
Sites / Locations
- Samsune Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Guideline-directed medical treatment group
Revascularization group
In the GDMT group, medical treatment for patients with left ventricular dysfunction will be performed under current ACC/AHA/SCAI or ESC/EACTS guidelines for heart failure.
In the revascularization group, patients will undergo percutaneous coronary intervention (PCI) using standard techniques under current ACC/AHA/SCAI or ESC/EACTS guidelines. In the revascularization group, the procedure must be within 2 weeks of randomization. Revascularization criteria is presented as below. Revascularization indication Diameter stenosis >90% by visual assessment Functionally significant stenosis (FFR≤0.80 or non-hyperemic pressure ratios≤0.89) Chronic total occlusion with substantial ischemic territory. The below locations will be judged as having substantial ischemic territory. Left main artery Proximal to mid left anterior descending artery Proximal left circumflex artery in left dominant coronary arterial system Proximal to distal right coronary artery in right dominant coronary arterial system