CABG, CABG in Low EF, Coronary Artery Disease, Coronary Artery Disease (CAD), Heart Failure, Multivessel Coronary Artery Disease, PCI, Revascularization
Conditions
Keywords
coronary artery, coronary artery disease, heart failure, low ejection fraction, hfref, cabg, coronary artery bypass graft, pci, revascularization
Brief summary
This randomized multicenter trial compares coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) in 358 patients with ischemic left ventricular dysfunction and multivessel coronary disease. The study evaluates differences in survival, major cardiovascular events, and quality of life over 4 years, and contributes to the international STICH 3.0 collaboration assessing long-term outcomes.
Detailed description
Patients with ischemic left ventricular systolic dysfunction (iLVSD) and multivessel coronary artery disease (CAD) have a poor prognosis. Coronary artery bypass grafting (CABG) has been shown to improve long-term survival in this population compared to medical therapy alone. However, CABG carries higher short-term risks, leading to underutilization in older and comorbid patients. In contrast, percutaneous coronary intervention (PCI) is frequently performed due to perceived lower procedural risk, despite limited evidence supporting its benefit in patients with LV dysfunction. Previous studies comparing PCI with medical therapy excluded patients with clear indications for revascularization, such as those with significant angina or recent acute coronary syndrome, leaving uncertainty about the optimal treatment strategy. The STICH 3.0-NL trial is a prospective, randomized, controlled, open-label, multicenter study designed to compare CABG and PCI in patients with iLVSD (LVEF \<40%) and multivessel CAD who are candidates for coronary revascularization. A total of 358 patients will be enrolled and randomized in a 1:1 ratio to undergo CABG or PCI, aiming for full revascularization. The primary endpoint is a hierarchical composite of all-cause mortality, recurrent major adverse cardiovascular events (MACE: non-procedural myocardial infarction, stroke, or unplanned revascularization), and recurrent hospitalizations for heart failure at 4 years. Secondary endpoints include the individual components of the primary endpoint, cardiovascular mortality, periprocedural myocardial infarction, target vessel and lesion revascularization, changes in quality of life (Seattle Angina Questionnaire and KCCQ), and cost-effectiveness expressed as QALY and ICER. The STICH 3.0-NL trial will contribute approximately 10% of the total cohort to the international STICH 3.0 collaboration, enabling long-term analyses of all-cause mortality at 5 and 10 years and providing critical evidence to guide revascularization strategies in patients with ischemic cardiomyopathy.
Interventions
PROCEDURECABG
CABG (coronary artery bypass grafting)
PROCEDUREPCI
PCI (percutaneous coronary intervention)
Sponsors
University Medical Center Groningen
Dutch Heart Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * LVEF≤ 40% * Angina pectoris, CCS≥2 and/or hospitalization for ACS or heart failure within 1 year prior to randomization * Multivessel CAD (2-3 vessel-disease with coronary lesions \>70% and involvement of proximal LAD, and/or LM stenosis of \>50%). Target vessels are determined by the local Heart Time * Clinical and angiographical characteristics suitable for isolated coronary revascularization both by CABG or PCI according to the judgment of the local Heart Team * Written informed consent
Exclusion criteria
* ACS \< 48 hours before randomization * Valvular/structural heart disease requiring intervention * Contra-indications to DAPT * Non-cardiac condition with life expectancy \< 1 year * Previous CABG * Decompensated HF at the time of inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hierarchical composite of all-cause mortality, major adverse cardiovascular events, and heart failure hospitalizations | 4 years | Outcomes will be analyzed using a hierarchical (win ratio / Finkelstein-Schoenfeld) approach to account for clinical severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual components of the primary endpoint | 4 years | Analysis of each component of the primary endpoint separately - all-cause mortality, non-procedural myocardial infarction, stroke, unplanned revascularization, and heart failure hospitalizations. |
| Cardiovascular mortality | 4 years | Death due to cardiovascular causes |
| Periprocedural myocardial infarction | Within 30 days post-procedure | Myocardial infarction occurring during or within 30 days after the index revascularization procedure. |
| Target vessel and target lesion revascularization | 4 years | Any repeat revascularization of the initially treated coronary vessel or lesion. |
| Change in quality of life - Kansas City Cardiomyopathy Questionnaire | at 1 and 4 years (compared to baseline) | Change in patient-reported quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is scored 0-100 per domain, with higher scores indicating better health status. A positive change from baseline reflects improvement. A ≥5-point change is considered clinically meaningful. |
| Changes in quality of life - Seattle Angina Questionnaire | at 1 and 4 years (compared to baseline) | Change in patient-reported quality of life assessed using the Seattle Angina Questionnaire (SAQ). The SAQ is scored in 5 domains from 0-100 per domain, with higher scores indicating fewer symptoms and better health status. A change of ≥5 points is generally considered clinically meaningful. |
| Cost-effectiveness | 4 years | Cost-effectiveness analysis comparing CABG and PCI, expressed as quality-adjusted life years (QALY) and incremental cost-effectiveness ratio (ICER). |
Countries
Netherlands
Contacts
CONTACTErik Lipsic, Dr
CONTACTRuben R. De With, Dr
PRINCIPAL_INVESTIGATORErik Lipsic, Dr
University Medical Center Groningen
Outcome results
None listed