Actively Recruiting
Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function
Led by University Medical Center Groningen · Updated on 2026-05-12
358
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
D
Dutch Heart Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in patients with ischemic left ventricular systolic dysfunction (LVEF less than 40%) and multivessel coronary artery disease. This randomized multicenter trial involves 358 patients and aims to compare survival, major cardiovascular events, and quality of life over 4 years. The study also contributes to the international STICH 3.0 collaboration for long-term outcome analysis. Participants will be randomly assigned to receive either CABG or PCI, both aiming for full revascularization of the affected coronary vessels. CABG is a surgical procedure, while PCI is a less invasive percutaneous procedure. The study is open-label and controlled, conducted at multiple centers, ensuring careful evaluation of each treatment method in appropriate candidates. During the 4-year follow-up, researchers will measure a composite outcome including all-cause mortality, major adverse cardiovascular events, and heart failure hospitalizations. Quality of life will be assessed at 1 and 4 years using the Kansas City Cardiomyopathy Questionnaire and the Seattle Angina Questionnaire. Additional outcomes include cardiovascular mortality, procedural myocardial infarction, revascularization rates, and cost-effectiveness. Participants will be monitored closely for safety and clinical status throughout the study.
CONDITIONS
Brief Title
Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function (STICH 3.0-NL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Left ventricular ejection fraction of 40% or less
- Angina pectoris with Canadian Cardiovascular Society class 2 or higher and/or hospitalization for acute coronary syndrome or heart failure within 1 year prior to randomization
- Multivessel coronary artery disease with 2-3 vessel disease, including significant lesions (>70%) in proximal left anterior descending artery and/or left main stenosis (>50%)
- Clinical and angiographical suitability for isolated coronary revascularization by either CABG or PCI as judged by the local Heart Team
- Ability to provide written informed consent
You will not qualify if you...
- Acute coronary syndrome within 48 hours before randomization
- Valvular or structural heart disease requiring intervention
- Contraindications to dual antiplatelet therapy (DAPT)
- Non-cardiac condition with life expectancy less than 1 year
- Previous coronary artery bypass graft surgery
- Decompensated heart failure at the time of inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days post-procedure
Participants randomized to the surgery group undergo coronary artery bypass grafting (CABG) aiming for full revascularization followed by immediate recovery care.
1 procedure visit and approximately 1 follow-up visit within 30 days
Duration - Up to 30 days post-procedure
Participants randomized to the percutaneous group undergo percutaneous coronary intervention (PCI) aiming for full revascularization.
1 procedure visit and approximately 1 follow-up visit within 30 days
Duration - 4 years
Participants are monitored for up to 4 years to assess mortality, major adverse cardiovascular events, hospitalizations for heart failure, and quality of life changes.
Assessments at 1 year and 4 years, with additional monitoring visits as needed
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
E
Erik Lipsic, Dr
R
Ruben R. De With, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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