Percutaneous coronary intervention: PCI will be performed according to standard techniques. Use of a contemporary, FDA/CE-approved drug-eluting stent is mandatory.
Guideline-directed medical therapy: GDMT 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years at screening.
2. Documented LVEF ≤40% assessed by quantitative transthoracic echocardiography confirmed at the core laboratory within 90 days prior to randomization.
3. 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.
4. 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.
5. On stable GDMT for at least 4 weeks prior to randomization under the advisor's assessment at each site.
6. The subject, or their legal guardian, has a clear understanding of the trial's design and procedures, provide written informed consent, and is able to comply with all follow-up procedures.
Exclusion Criteria:
1. Class III or IV angina requiring revascularization.
2. Any unplanned hospitalization within 30 days.
3. Any PCI within 12 months.
4. Any prior CABG.
5. Cardiogenic shock or end-stage heart failure (NYHA class IVb - unable to ambulate)
6. Non-cardiac life expectancy \<1 year at screening (e.g., malignancy, advanced liver disease).
7. Coronary anatomy requiring surgical revascularization by local heart team determination.
8. Coronary anatomy unsuitable for PCI.
9. HF due to specific cardiomyopathies, including restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic obstructive cardiomyopathy (HOCM).
10. Severe stenosis or regurgitation of any heart valve.
11. Contraindication to dual antiplatelet therapy or iodinated contrast.
12. Pregnancy, lactation, or women of childbearing potential not using effective contraception. A negative urine pregnancy test is required within 7 days prior to randomization for women of childbearing potential.
13. Participation in another interventional trial that may interfere with the PCI and GDMT as specified in this protocol.
14. Any other circumstances that the investigator deems inappropriate for participation, including but not limited to conditions that may jeopardize patient safety, confound data interpretation, or patients unlikely to comply with study procedures.
Primary outcome measure(s)
Major adverse cardiovascular events (MACE) — From randomization to the time when the last enrolled patient reaches 12-month follow-up. 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.
Trial sites (1)
Facility
City
Region
Status
Nanjing First Hospital, Nanjing Medical University
Nanjing
Jiangsu
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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