Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function (STICH 3.0-NL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CABG, PCI.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Coronary Artery Disease (CAD), Multivessel Coronary Artery Disease, CABG. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function
Overview
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
- Procedure CABG
CABG (coronary artery bypass grafting) - Procedure PCI
PCI (percutaneous coronary intervention)
Primary outcome measures
- Hierarchical composite of all-cause mortality, major adverse cardiovascular events, and heart failure hospitalizations [Time frame: 4 years]
Secondary outcome measures (7)
- Individual components of the primary endpoint [Time frame: 4 years]
- Cardiovascular mortality [Time frame: 4 years]
- Periprocedural myocardial infarction [Time frame: Within 30 days post-procedure]
- Target vessel and target lesion revascularization [Time frame: 4 years]
- Change in quality of life - Kansas City Cardiomyopathy Questionnaire [Time frame: at 1 and 4 years (compared to baseline)]
- Changes in quality of life - Seattle Angina Questionnaire [Time frame: at 1 and 4 years (compared to baseline)]
- Cost-effectiveness [Time frame: 4 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Identifiers
NCT: NCT07269366 · NL-009839 · 01-001-2024-0545