University Medical Center Groningen
Groningen, Netherlands
Location status: Recruiting
NCT Number: NCT07269366
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Groningen, Netherlands
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CABG (coronary artery bypass grafting)
PCI (percutaneous coronary intervention)
Time frame: 4 years
Outcomes will be analyzed using a hierarchical (win ratio / Finkelstein-Schoenfeld) approach to account for clinical severity
Time frame: 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.
Time frame: 4 years
Death due to cardiovascular causes
Time frame: Within 30 days post-procedure
Myocardial infarction occurring during or within 30 days after the index revascularization procedure.
Time frame: 4 years
Any repeat revascularization of the initially treated coronary vessel or lesion.
Time frame: 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.
Time frame: 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.
Time frame: 4 years
Cost-effectiveness analysis comparing CABG and PCI, expressed as quality-adjusted life years (QALY) and incremental cost-effectiveness ratio (ICER).
Contact information is provided by the study sponsor or research team.
Erik Lipsic, Dr
CONTACT
Ruben R. De With, Dr
CONTACT
University Medical Center Groningen
Other
Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function
Acronym: STICH 3*0-NL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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