Revascularization versus Medical Treatment in Patients with Ischemic Left Ventricular dysfunctio

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 900

Inclusion Criteria

1) Inclusion criteria
?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

2) 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.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first event of MACE (a composite of death, MI, admission for heart failure, advanced heart failure requiring LVAD or transplantation)

Secondary Outcome Measures

Name	Time	Method
All-cause death;Cardiac death;Any MI, defined by Forth Universal definition of MI;Spontaneous MI, defined by Forth Universal definition of MI;Procedure-related MI, defined by ARC II definition;Admission for heart failure (acute decompensated heart failure);Advanced heart failure requiring LVAD or transplantation;Incidence of Implantable cardioverter-defibrillator (ICD) or Cardiac resynchronization therapy (CRT-D) for documented ventricular tachycardia or ventricular fibrillation (secondary prevention).;Clinically-indicated unplanned revascularization;Stroke (ischemic or hemorrhagic);EQ-5D-5L (quality of life) at 6 month;SAQ (angina severity) at 6 month;Total medical cost;Left ventricular ejection fraction at 6 month – 1 year follow-up;NT-proBNP, pg/mL at 6 month – 1 year follow-up