To evaluate whether percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) combined with guideline-directed medical therapy (GDMT), compared to GDMT alone, reduces the time to first occurrence of major adverse cardiovascular events (MACE) during a median follow-up of at least 24 months, measured at the time the last enrolled patient reaches 12 months, in patients with ischemic cardiomyopathy and left-ventricular ejection fraction (LVEF) ≤40%. MACE is a composite of cardiovascular \[CV\] death, myocardial infarction (MI), heart failure (HF) related rehospitalization, heart transplantation, requirement for durable left ventricular assist device \[LVAD\] implantation, or worsening heart failure treated as an out-patient requiring treatment with intravenous medications.
Age ≥18 years at screening.
Documented LVEF ≤40% assessed by quantitative transthoracic echocardiography confirmed at the core laboratory within 90 days prior to randomization.
Symptomatic heart failure (NYHA Functional Class II, III, or ambulatory Class IVa) or hospitalization for heart failure within the prior 12 months or NT-proBNP ≥600 pg/mL.
Angiographically proven CAD with at least one lesion with 1) a visually estimated diameter stenosis (DS) of ≥90% or 2) chronic total occlusion with a high likelihood (>80%) of PCI success, or 3) a visually estimated DS of <90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions considered amenable to PCI with DES by an interventional cardiologist.
Class III or IV angina requiring revascularization.
Any unplanned hospitalization within 30 days.
Any PCI within 12 months.
Any prior CABG.
Parallel
Percutaneous coronary intervention
Procedure/SurgeryPCI will be performed according to standard techniques. Use of a contemporary, FDA/CE-approved drug-eluting stent is mandatory.
Guideline-directed medical therapy
DrugGDMT optimization follows a structured titration algorithm: Week 0: introducing angiotensin-converting enzyme inhibitor (ACEi)/ angiotensin II receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitors (ARNI) and beta-blockers. Week 1: adding mineralocorticoid receptor antagonist (MRA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i). Adjust every 2-4 weeks to reach target or tolerable dose unless symptomatic hypotension (systolic blood pressure \[SBP\] \< 90 mmHg) or estimated glomerular filtration rate (eGFR) drop \> 30 % or serum potassium \>5.2 mmol/L.
Major adverse cardiovascular events (MACE)
MACE is a composite of cardiovascular \[CV\] death, myocardial infarction, HF-related rehospitalization, heart transplantation, requirement for durable LVAD, or worsening heart failure treated as an out-patient requiring treatment with intravenous medications (out-patient worsening HF) through a median of at least 24-month follow-up, measured at the time the last enrolled patient reaches 12-month follow-up.
Rate of cardiovascular death plus myocardial infarction and revascularization
This endpoint measures the time to first occurrence of any component of the composite of cardiovascular death, myocardial infarction, or unplanned ischemia-driven revascularization.
Rate of cardiovascular death
A death that is primarily caused by a cardiovascular event or condition. This includes deaths resulting from acute myocardial infarction, stroke, heart failure, arrhythmias, and other cardiovascular diseases.
Rate of myocardial infarction
The diagnosis of an myocardial infarction should be made according to standard clinical practice but is expected to align with the criteria from Fourth Universal Definition of MI, i.e. detection of a rise and/or fall of cardiac biomarkers such as troponin and at least one of the following: typical clinical symptoms, ischaemic ECG findings, imaging evidence of myocardial injury, or detection of an intracoronary thrombus by angiography or autopsy.
Rate of any unplanned revascularization
Unplanned revascularization includes all coronary revascularization procedures (PCI/CABG) performed during the study.
Rate of Stroke
Rate of stroke refers to the frequency of new, acute cerebrovascular events occurring in a study population.
Rate of Major bleeding
Major bleeding is defined as bleeding at BAR 3 grade or above.
Rate of contrast-associated acute kidney injury
Contrast-associated acute kidney injury (CA-AKI), defined according to the PC-AKI criteria as an increase in serum creatinine by ≥26.5 μmol/L or to ≥1.5 times the baseline level within 48 hours after contrast administration.
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