The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 754
- 试验地点
- 82
- 主要终点
- The Primary outcome is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission.
研究概览
简要总结
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH3C) trial is a prospective, unblinded, international multi-center randomized trial of 754 subjects enrolled in approximately 45 centers comparing revascularization by percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) in patients with multivessel/left main (LM) coronary artery disease (CAD) and reduced left ventricular ejection fraction (LVEF).
The primary objective is to determine whether CABG compared to PCI is associated with a reduction in all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in patients with multivessel/LM CAD and ischemic left ventricular dysfunction (iLVSD).
Eligible patients are considered by the local Heart Team appropriate and amenable for non-emergent revascularization by both modes of revascularization.
The secondary objectives are to describe the early risks of both procedures, and a comprehensive set of patient-reported outcomes longitudinally.
详细描述
The evidence comparing PCI and CABG with medical therapy in patients with iLVSD has been the subject of multiple systematic reviews/meta-analyses of observational studies with inconsistent results. There is a current lack of evidence from properly powered randomized trials comparing contemporary state-of-the-art PCI vs. CABG to guide the clinical management in the vulnerable population of patients with iLVSD. Understanding the relative impact of both revascularization strategies on clinical outcomes in this prevalent population would have important clinical implications.
The overarching aim of the STICH3C trial is to compare the clinical efficacy and safety of contemporary PCI and CABG to treat patients with multivessel/left main (LM) CAD and iLVSD.
Participants will be allocated in a 1:1 ratio to either study arm using permuted block randomization stratified for study center and acute coronary syndrome (ACS) presentation through a centrally controlled, automated, web system. Eligible patients who provide informed consent can be enrolled. It is expected that initial revascularization will take place within 2 weeks of randomization. Staged PCI is expected to take place within 90 days of randomization. The recruitment will occur over 3 years, with a total study duration of 7 years, and a median duration of follow-up of 5 years.
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
- Single (Outcomes Assessor)
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;
- •LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
- •Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant coronary stenosis is defined as ≥ 70% based on coronary angiography, and/or fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.
- •For LM disease, significant coronary stenosis is defined as >50% based on coronary angiography, intravascular ultrasound (IVUS) minimal luminal area (MLA) ≤6.0 mm2 (<4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements;
- •The institutional Heart Team agrees that guideline-directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or without acute coronary syndrome (ACS)) requiring revascularization before discharge, GDMT needs to be initiated, when possible in-hospital before randomization, with the expectation that it will be titrated to maximally tolerated doses after revascularization;
- •Signed informed consent.
排除标准
- •Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization;
- •Recent (<4 weeks) ST-elevation MI;
- •Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
- •Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
- •Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
- •Prior cardiac surgery;
- •Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
- •Circumstances likely to lead to poor treatment adherence;
- •Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years;
- •Current pregnancy;
- •Patient not amenable to both CABG or PCI according to the Heart Team;
- •Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome.
研究组 & 干预措施
Revascularization by PCI
Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter >2.0 mm for PCI. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon.
干预措施: Revascularization by PCI (Procedure)
Revascularization by CABG
Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter >1.5 mm for CABG. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon
干预措施: Revascularization by CABG (Procedure)
结局指标
主要结局
The Primary outcome is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission.
时间窗: Median follow-up of 5 years.
Time to event outcome measured as the time from randomization to the occurence of the first event.
次要结局
- Myocardial Infarction (MI)(At 30 days and through study completion with a median follow-up of 5 years.)
- Death(At 30 days , 90 days and through study completion with a median follow-up of 5 years.)
- Coronary composite endpoint(Through study completion with a median follow-up of 5 years.)
- Number of participants with advanced Heart failure therapies(Through study completion with a median follow-up of 5 years.)
- Number of participants with Stroke(At 30 days , 90 days and through study completion with a median follow-up of 5 years.)
- Composite of death/stroke/spontaneous MI(Through study completion with a median follow-up of 5 years.)
- Major Adverse Events(Results will be reported at 30 days and 90 days after index procedure (and 30 days after any planned staged PCI, allowed up to 90 days after randomization) as cardiac surgical hospitalizations maybe prolonged.)
- Composite of death or cardiac hospitalization(Through study completion with a median follow-up of 5 years.)
- Heart Failure endpoint(Through study completion with a median follow-up of 5 years.)
- Repeat Revascularization (RR)(At 30 days , 90 days and through study completion with a median follow-up of 5 years.)
- Hospitalizations(Through study completion with a median follow-up of 5 years.)
- Composite of death/stroke/spontaneous MI/RR(Through study completion with a median follow-up of 5 years.)
- Hierarchal Heart Failure outcome(Through study completion with a median follow-up of 5 years.)
研究者
Stephen E. Fremes
Professor of Surgery, University of Toronto
Sunnybrook Health Sciences Centre