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

NCT07349979 | Not Yet Recruiting DMC

• 2 other identifiers: KY20251223-09BE2019615
• Study Type: interventional
• Target: 1,154
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction; Coronary Artery Disease; Stable GDMT

Keywords

HFrEF; PCI; GDMT; MACE

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization to the time when the last enrolled patient reaches 12-month follow-up.

Secondary Outcomes (13)

• Rate of cardiovascular death plus myocardial infarction and revascularization

  The last patient reaches the 12-month follow-up

• Rate of cardiovascular death

  The last patient reaches the 12-month follow-up

• Rate of myocardial infarction

  The last patient reaches the 12-month follow-up period

• Rate of any unplanned revascularization

  The last patient reaches the 12-month follow-up period

• Rate of heart failure-related rehospitalization

  The last patient reaches the 12-month follow-up period

Other Outcomes (3)

• Rate of Stroke

  The last patient reaches the 12-month follow-up period

• Rate of Major bleeding

  The last patient reaches the 12-month follow-up period

• Rate of contrast-associated acute kidney injury

  Within 48 hours after contrast administration

Study Arms (2)

PCI with contemporary DES + GDMT

ACTIVE COMPARATOR

A total of 1154 patients with LVEF ≤40%, angiographically proven coronary artery disease (CAD) amenable to PCI, and symptomatic heart failure (NYHA Class II-IV) on stable GDMT，will be assigned at 1:1 ratio to two arms. Angiographically proven CAD is defined as 1) a visually estimated diameter stenosis (DS) of ≥90%, or 2) a chronic total occlusion with a high likelihood (\>80%) of PCI success, or 3) a visually estimated diameter stenosis (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 are considered amenable to PCI with DES by an interventional cardiologist. Randomization will be stratified by the presence of planned CTO PCI, planned left main PCI and center. Complete revascularization of all angiographically significant lesions is encouraged, to be performed either during the index procedure or within a staged procedure within 30 days.

Procedure: Percutaneous coronary intervention; Drug: Guideline-directed medical therapy

GDMT only

ACTIVE COMPARATOR

The control group will receive GDMT; this is approved treatments for preventing HF that could be utilised as a comparator. All patients will be treated according to local guidelines on standard of care treatment for patients with HFrEF and post PCI, focusing on treatment of HF symptoms (e.g. diuretics) and comorbidities (including treatment for high blood pressure, ischaemic heart disease).

Drug: Guideline-directed medical therapy

Interventions

Guideline-directed medical therapy DRUG

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.

Also known as: GDMT

GDMT only; PCI with contemporary DES + GDMT

Percutaneous coronary intervention PROCEDURE

PCI will be performed according to standard techniques. Use of a contemporary, FDA/CE-approved drug-eluting stent is mandatory.

Also known as: PCI

PCI with contemporary DES + GDMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Class III or IV angina requiring revascularization.
• Any unplanned hospitalization within 30 days.
• Any PCI within 12 months.
• Any prior CABG.
• 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.
• Coronary anatomy unsuitable for PCI.
• HF due to specific cardiomyopathies, including restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic obstructive cardiomyopathy (HOCM).
• Severe stenosis or regurgitation of any heart valve.
• 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.
• Participation in another interventional trial that may interfere with the PCI and GDMT as specified in this protocol.
• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Shao-Liang Chen, MD

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shao-Liang Chen, MD

CONTACT

+86-25-52271351; chmengx@126.com

Jing Kan, PhD

CONTACT

+86-25-52279862; kanjingok@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Given the nature of the intervention (PCI vs. no PCI), treating physicians and patients cannot be blinded. To minimize bias, a PROBE design is employed with a blinded independent Clinical Events Committee (CEC), blinded core laboratories, and blinded statisticians. The catheterization laboratory team is unblinded but not involved in follow-up decisions or endpoint assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: PCI with DES plus GDMT versus GDMT alone

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 20, 2026
• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)