About this trial
To compare the effects of physiology- and imaging-guided PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricular systolic function in patients with ischemic cardiomyopathy and multivessel coronary artery disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must be ≥ 19 years
Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Subject with LV ejection fraction <40% from cardiac MRI
Subject with multivessel disease in major epicardial coronary artery disease or their major branches (vessel size of 2.5 mm or more than 2.5mm) considering coronary revascularization
Disqualifiers
Subjects with more than 50% transmural extent of infarction on GE-MRI in more than 25% of the dysfunctional myocardial segments
Subject with suspicious of other cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyopathy etc.)
Subject with recent myocardial infarction within 4 weeks
Subject with recent fatal arrhythmia (VT or VF) within 4 weeks
Trial design
Parallel
Treatments tested in this trial
Physiology-and imaging-guided PCI
Procedure/SurgeryThe criteria for performing revascularization are as follows 1. Lesions with ≥50% diameter stenosis and FFR ≤ 0.80, or lesions with severe stenosis (\>90%) 2. In vessels meeting the above criteria, IVUS findings consistent with either: * Minimum lumen area (MLA) ≤ 3 mm² * 3 mm² \< MLA ≤ 4 mm² and plaque burden \>70% For all target vessels and lesions identified for intervention, optimal revascularization should be pursued. The criteria for optimal revascularization are as follows, and operators are encouraged to achieve them: 1. Post-PCI FFR \> 0.86 in all treated vessels is recommended, with a minimum threshold of post-PCI FFR \> 0.80 to achieve functional complete revascularization. 2. Post-PCI ΔFFR (defined as \[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05 is recommended. 3. On IVUS, achieving a minimum stent area (MSA) \> 5.5 mm² and MSA/average reference lumen \> 80% is recommended.
Optimal medical treatment
DrugAll study participants will receive guideline-directed medical therapy. Even for patients assigned to the optimal medical therapy group, revascularization may be performed during follow-up if clinically indicated. If such a decision is made prior to the primary endpoint assessment, a gadolinium-enhanced cardiac MRI will be performed at the time of consideration to reassess myocardial viability.
Treatment groups
Trial outcomes
Primary outcomes
LV ejection fraction from GE-MRI
LV ejection fraction from gadolinium-enhanced MRI
Secondary outcomes
Changes in the transmural extent of myocardial infarction from GE-MRI
Changes in the transmural extent of myocardial infarction from GE-MRI
Number of improved dysfunctional myocardial segments from GE-MRI
Number of improved dysfunctional myocardial segments from GE-MRI
Changes in the LV chamber size from GE MRI
Changes in the LV chamber size from GE MRI
LV ejection fraction from echocardiography
LV ejection fraction from echocardiography
Sponsors and contacts
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Seoul National University Hospital
Lead sponsor
Seoul National University Bundang Hospital
Collaborator
Seoul National University Boramae Hospital
Collaborator