PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF

Korábbi kezelés

• Any prior CABG.
• Contraindication to dual antiplatelet therapy or iodinated contrast.
• 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.

Más betegség

• Class III or IV angina requiring revascularization.
• Cardiogenic shock or end-stage heart failure (NYHA class IVb - unable to ambulate)
• Non-cardiac life expectancy <1 year at screening (e.g., malignancy, advanced liver disease).
• Coronary anatomy requiring surgical revascularization by local heart team determination.
• Severe stenosis or regurgitation of any heart valve.
• 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.

Egyéb

• Any unplanned hospitalization within 30 days.
• Any PCI within 12 months.
• Coronary anatomy unsuitable for PCI.
• HF due to specific cardiomyopathies, including restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic obstructive cardiomyopathy (HOCM).
• Participation in another interventional trial that may interfere with the PCI and GDMT as specified in this protocol.

• 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.
• On stable GDMT for at least 4 weeks prior to randomization under the advisor's assessment at each site.
• 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.