CABG or PCI in Patients With Ischemic Cardiomyopathy

Study Overview
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Brief Summary
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The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) < 40%) and multi-vessel coronary artery disease.

Detailed Description
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Short background/ Rationale/Aim: CABG has been shown to prolong survival in patients with reduced left ventricular (LV) function and multi-vessel coronary artery disease and CABG is recommended as the ﬁrst revascularization strategy choice in patients with multi-vessel disease and acceptable surgical risk. However, a major concern with CABG is the early risk of complications, including death and stroke. Although PCI has lower rates of peri-procedural complications than CABG in patients without heart failure (HF), this has not been confirmed in patients with HF. The lack of contemporary data comparing CABG and PCI in HF leaves clinicians with no guidance as to which option to choose, and a robust trial is therefore necessary. The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) < 40%) and multi-vessel coronary artery disease. Study objective: To test whether PCI is non-inferior to CABG for revascularization of patients with ischemic heart failure. Study design: Multicentre, open-label, randomized controlled trial Study population: Patients with ischemic cardiomyopathy and reduced ejection fraction. Number of subjects: 470 subjects Investigational treatment: PCI Treatment in control group: CABG Study endpoints: Primary endpoint (variable): The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization at 3 years. Key secondary endpoint The hierarchical occurrence (in descending order of importance) at 3-year follow-up of time to death, time to stroke, time to non-procedural myocardial infarction, number of heart failure hospitalizations and 1-year Kansas City Cardiomyopathy Questionnaire (KCCQ) score; evaluated using the win ratio approach. Secondary safety endpoints In-hospital occurrence of the following: Death Stroke Non-procedural myocardial infarction The occurrence of in-hospital BARC ≥3 bleeding Time to the occurrence of the following: Mediastinitis Pericardial tamponade Other secondary endpoints 1. Time to the occurrence of the following: A. Death, stroke or non-procedural myocardial infarction B. Death or heart failure hospitalization C. Heart failure hospitalization D. Coronary revascularization E. Death or myocardial infarction F. Death or stroke 2. Total number of days in-hospital during index hospitalization 3. Total number of days in intensive care unit during index hospitalization 4. Quality of life at 30 days and 365 days.

Official Title
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CABG or PCI in Patients With Ischemic Cardiomyopathy - A Randomized Registry Clinical Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention (PCI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years. Symptomatic HF defined as NYHA HF class II-IV within 1 month of enrolment LVEF < 40% quantified by either echocardiography or gated SPECT ventriculography, or magnetic resonance (MR) or any other recognized assessment of LVEF Meaningful amount of myocardium at risk because of CAD (BCIS myocardial jeopardy score >6 on a recent (<6 months) coronary angiogram); Heart team believes that a meaningful revascularization can be achieved by both PCI or CABG, with complete revascularization defined as residual ischemia in <10% of the left ventricle Written informed consent obtained Exclusion Criteria: Previous randomization in the study Decompensated heart failure 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 (<1 month) type 1 myocardial infarction Recent PCI (<3 months) Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) requiring surgical repair/replacement Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy Expected survival less than 3 years due to non-cardiac illness Circumstances likely to lead to poor treatment compliance Individuals for whom record in public health databases is not accessible (non-eligibility to public health system, parallel healthcare systems Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An open-label, multicentre randomized registry trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Coronary Intervention (PCI)<br>Patients will be revascularized by PCI | Procedure: Percutaneous Coronary Intervention (PCI)<br>* Alternative treatment<br>|
| No Intervention: Coronary artery bypass grafting (CABG)<br>Patients will be revascularized by CABG | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac event | The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of death | Time to death | 3 years | 
| The occurrence of stroke | Time to stroke | 3 year | 
| The occurrence of non-procedural myocardial infarction, | Time to non-procedural myocardial infarction, | 3 year | 
| The occurrence of heart failure hospitalizations | Number of heart failure hospitalizations | 3 year | 
| Kansas City Cardiomyopathy Questionnaire (KCCQ) score | Kansas City Cardiomyopathy Questionnaire score; evaluated using the win ratio approach. High score mean a better outcome | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, CABG