Percutaneous Coronary Intervention With Guideline-Directed Medical Therapy Versus Guideline-Directed Medical Therapy Alone for Patients With Ischemic Cardiomyopathy and Reduced Left Ventricular Ejection Fraction: A Randomized, Controlled, Open-Label, Multicenter PCI-GULF Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,154
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events
研究概览
简要总结
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.
详细描述
A prospective, randomized, controlled, open-label, multicenter trial with blinded endpoint adjudication (PROBE design)
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:
Experimental Group: PCI with contemporary DES + GDMT. Control Group: GDMT alone.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
PCI with contemporary DES + GDMT
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.
干预措施: Percutaneous coronary intervention (Procedure)
PCI with contemporary DES + GDMT
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.
干预措施: Guideline-directed medical therapy (Drug)
GDMT only
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).
干预措施: Guideline-directed medical therapy (Drug)
结局指标
主要结局
Major adverse cardiovascular events
时间窗: From randomization to the 12-month follow-up period
MACE is a composite of cardiovascular \[CV\] death, spontaneous myocardial infarction (MI), any unplanned revascularization, heart failure (HF)-related rehospitalization, heart transplantation, requirement of device implantation (e.g., valvular treatment, pacemaker, or left ventricular assist device \[LVAD\]), or requirement of intravenous medications due to worsening heart failure in outpatients.
次要结局
- Rate of cardiovascular death plus myocardial infarction and revascularization(From randomization to the 12-month follow-up period)
- Rate of cardiovascular death(From randomization to the 12-month follow-up period)
- Rate of myocardial infarction(From randomization to the 12-month follow-up period)
- Rate of any unplanned revascularization(From randomization to the 12-month follow-up period)
- Rate of heart failure-related rehospitalization(From randomization to the 12-month follow-up period)
- Incidence of device implantation procedure(From randomization to the 12-month follow-up period)
- Heart transplantation(From randomization to the 12-month follow-up period)
- Rate of worsening heart failure(From randomization to the 12-month follow-up period)
- All-cause mortality(From randomization to the 12-month follow-up period)
- Change in LVEF(From randomization to the 12-month follow-up period)
- Change from baseline in NT-proBNP concentration at 12 months(From randomization to the 12-month follow-up period)
- Total number of (first and recurrent) MACE(From randomization to the 12-month follow-up period)
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)(From randomization to the 12-month follow-up period)
研究者
Shaoliang Chen, MD
Principal Investigator
Nanjing First Hospital, Nanjing Medical University