Coronary Artery DiseaseSTICH 3*0-NLNCT07269366
Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function (STICH 3.0-NL)
A study testing CABG and PCI in people with Coronary Artery Disease and Coronary Artery Disease (CAD), run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Disease (CAD), Multivessel Coronary Artery Disease
- What is being tested?
- CABG and PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2026to May 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen
Erik Lipsic, Dr., +31503612355, e.lipsic@umcg.nl
About this study
Official title: Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (CAD), Multivessel Coronary Artery Disease, CABG, CABG in Low EF, Heart Failure
- Being tested
- CABG, PCI
- Keywords
- coronary artery, coronary artery disease, heart failure, low ejection fraction, hfref, cabg, coronary artery bypass graft, pci, revascularization
- Medical subject headings
- Coronary Artery Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABGProcedure or surgery
CABG (coronary artery bypass grafting)
PCIProcedure or surgery
PCI (percutaneous coronary intervention)
| Study group | Role | What they receive |
|---|---|---|
| CABG (surgery) | Experimental | Patients randomized to CABG will receive CABG - aiming for full revascularization Receives: Procedure: CABG |
| PCI (percutaneous) | Other | Patients randomized to PCI will receive PCI - aiming for full revascularization Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite of all-cause mortality, major adverse cardiovascular events, and heart failure hospitalizations
Outcomes will be analyzed using a hierarchical (win ratio / Finkelstein-Schoenfeld) approach to account for clinical severity
Measured: 4 years
Secondary outcomes (7)
Individual components of the primary endpoint
Analysis of each component of the primary endpoint separately - all-cause mortality, non-procedural myocardial infarction, stroke, unplanned revascularization, and heart failure hospitalizations.
Measured: 4 years
Cardiovascular mortality
Death due to cardiovascular causes
Measured: 4 years
Periprocedural myocardial infarction
Myocardial infarction occurring during or within 30 days after the index revascularization procedure.
Measured: Within 30 days post-procedure
Target vessel and target lesion revascularization
Any repeat revascularization of the initially treated coronary vessel or lesion.
Measured: 4 years
Change in quality of life - Kansas City Cardiomyopathy Questionnaire
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.
Measured: at 1 and 4 years (compared to baseline)
Changes in quality of life - Seattle Angina Questionnaire
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.
Measured: at 1 and 4 years (compared to baseline)
Cost-effectiveness
Cost-effectiveness analysis comparing CABG and PCI, expressed as quality-adjusted life years (QALY) and incremental cost-effectiveness ratio (ICER).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startMay 2026 (estimated)
- Primary completionMay 2034 (estimated)
- Study completionMay 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Erik Lipsic, Dr, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269366
- Sponsor's protocol ID
- NL-009839
- Other IDs
- 01-001-2024-0545
- Acronym
- STICH 3*0-NL
- Status last verified
- May 2026
- First submitted
- 20 Nov 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function
- ClinicalTrials.gov ID
- NCT07269366
- Acronym / sponsor ID
- STICH 3*0-NL / NL-009839
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (CAD), Multivessel Coronary Artery Disease, CABG, CABG in Low EF, Heart Failure
- Keywords
- coronary artery, coronary artery disease, heart failure, low ejection fraction, hfref, cabg, coronary artery bypass graft, pci
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation
- Study start
- May 2026 (estimated)
- Primary completion
- May 2034 (estimated)
- Study completion
- May 2034 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG (surgery) | Experimental | Procedure: CABGPatients randomized to CABG will receive CABG - aiming for full revascularization |
| PCI (percutaneous) | Other | Procedure: PCIPatients randomized to PCI will receive PCI - aiming for full revascularization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CABGCABG (coronary artery bypass grafting) | Procedure or surgery | CABG (surgery) |
| PCIPCI (percutaneous coronary intervention) | Procedure or surgery | PCI (percutaneous) |
Primary outcome
Hierarchical composite of all-cause mortality, major adverse cardiovascular events, and heart failure hospitalizations
Time frame: 4 years
Outcomes will be analyzed using a hierarchical (win ratio / Finkelstein-Schoenfeld) approach to account for clinical severity
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erik Lipsic, Dr principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CABG and PCI in people with Coronary Artery Disease and Coronary Artery Disease (CAD), run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik Lipsic, Dr (+31 50 3612355, e.lipsic@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite of all-cause mortality, major adverse cardiovascular events, and heart failure hospitalizations (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.