Coronary Artery DiseaseSTICHNCT05329285
CABG or PCI in Patients With Ischemic Cardiomyopathy
A study testing Percutaneous Coronary Intervention (PCI) in people with Coronary Artery Disease, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) <40%) and multi-vessel coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous Coronary Intervention (PCI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteSweden
- Study dates
- 14 Sep 2022to 31 Dec 2052
- 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.
- Symptomatic HF defined as NYHA HF class II-IV within 1 month of enrolment
- LVEF ≤ 40% quantified by either echocardiography or gated SPECT ventriculography, or magnetic resonance (MR) or any other recognized assessment of LVEF
- Meaningful amount of myocardium at risk because of CAD (BCIS myocardial jeopardy score ≥ 6 on a recent (> 6 months) coronary angiogram);
- Heart team believes that a meaningful revascularization can be achieved by both PCI or CABG, with complete revascularization defined as residual ischemia in <10% of the left ventricle
- Heart team agrees that guideline directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or without acute coronary syndrome (ACS)) requiring revascularization before discharge, GDMT needs to be initiated, when possible, in-hospital before randomization, with the expectation that it will be titrated to maximally tolerated doses after revascularization
- Written informed consent obtained
Who cannot join
- Previous randomization in the study
- Decompensated heart failure requiring inotropic /adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization
- Recent (<1 month) type 1 myocardial infarction
- Recent PCI (<3 months)
- Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) requiring surgical repair/replacement
- Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy
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- Expected survival less than 3 years due to non-cardiac illness
- Circumstances likely to lead to poor treatment compliance
- Individuals for whom record in public health databases is not accessible (non-eligibility to public health system, parallel healthcare systems
- Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Kardiologen
Gothenburg, 41345
Björn Redfors, MD, PhD, 0313427543, bjoern.redfors@wlab.gu.se
Elmir Omerovic, MD, Prof, 0704560787, elmir@wlab.gu.se
About this study
Official title: CABG or PCI in Patients With Ischemic Cardiomyopathy - A Randomized Registry Clinical Trial
The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) <40%) and multi-vessel coronary artery disease.
Read the detailed description
Short background/ Rationale/Aim:
CABG has been shown to prolong survival in patients with reduced left ventricular (LV) function and multi-vessel coronary artery disease and "CABG is recommended as the first revascularization strategy choice in patients with multi-vessel disease and acceptable surgical risk". However, a major concern with CABG is the early risk of complications, including death and stroke. Although PCI has lower rates of peri-procedural complications than CABG in patients without heart failure (HF), this has not been confirmed in patients with HF. The lack of contemporary data comparing CABG and PCI in HF leaves clinicians with no guidance as to which option to choose, and a robust trial is therefore necessary. The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) < 40%) and multi-vessel coronary artery disease.
Study objective:
To test whether PCI is non-inferior to CABG for revascularization of patients with ischemic heart failure.
Study design:
Multicentre, open-label, randomized controlled trial
Study population:
Patients with ischemic cardiomyopathy and reduced ejection fraction.
Number of subjects:
470 subjects
Investigational treatment:
PCI
Treatment in control group:
CABG
Study endpoints:
Primary endpoint (variable):
The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization at 3 years.
Key secondary endpoint The hierarchical occurrence (in descending order of importance) at 3-year follow-up of time to death, time to stroke, time to non-procedural myocardial infarction, number of heart failure hospitalizations and 1-year Kansas City Cardiomyopathy Questionnaire (KCCQ) score; evaluated using the win ratio approach.
Secondary safety endpoints
In-hospital occurrence of the following:
- Death
- Stroke
- Non-procedural myocardial infarction
- The occurrence of in-hospital BARC ≥3 bleeding Time to the occurrence of the following:
- Mediastinitis
- Pericardial tamponade Other secondary endpoints
- Time to the occurrence of the following: A. Death, stroke or non-procedural myocardial infarction B. Death or heart failure hospitalization C. Heart failure hospitalization D. Coronary revascularization E. Death or myocardial infarction F. Death or stroke 2. Total number of days in-hospital during index hospitalization 3. Total number of days in intensive care unit during index hospitalization 4. Quality of life at 30 days and 365 days.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous Coronary Intervention (PCI)
- Keywords
- PCI, CABG
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention (PCI)Procedure or surgery
Alternative treatment
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Experimental | Patients will be revascularized by PCI Receives: Procedure: Percutaneous Coronary Intervention (PCI) |
| Coronary artery bypass grafting (CABG) | No intervention | Patients will be revascularized by CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac event
The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization
Measured: 3 years
Secondary outcomes (5)
The occurrence of death
Time to death
Measured: 3 years
The occurrence of stroke
Time to stroke
Measured: 3 year
The occurrence of non-procedural myocardial infarction,
Time to non-procedural myocardial infarction,
Measured: 3 year
The occurrence of heart failure hospitalizations
Number of heart failure hospitalizations
Measured: 3 year
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Kansas City Cardiomyopathy Questionnaire score; evaluated using the win ratio approach. High score mean a better outcome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start14 Sep 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2052 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Model description
- An open-label, multicentre randomized registry trial
- Masking
- None (open label)
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Region Örebro County, Karolinska University Hospital, University Hospital, Umeå
- Responsible party
- Sponsor
- Investigators
- Björn Redfors, Professor, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329285
- Sponsor's protocol ID
- EPM dnr 2021-04972
- Acronym
- STICH
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thuan PQ, Chuong PTV, Nam NH, Dinh NH. Coronary Artery Bypass Surgery: Evidence-Based Practice. Cardiol Rev. 2025 Jul-Aug 01;33(4):344-351. doi: 10.1097/CRD.0000000000000621. Epub 2023 Dec 19.
PubMed 38112423
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CABG or PCI in Patients With Ischemic Cardiomyopathy - A Randomized Registry Clinical Trial
- ClinicalTrials.gov ID
- NCT05329285
- Acronym / sponsor ID
- STICH / EPM dnr 2021-04972
- Conditions
- Coronary Artery Disease
- Keywords
- PCI, CABG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Region Örebro County, Karolinska University Hospital, University Hospital, Umeå
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2052 (estimated)
- First posted
- 15 Apr 2022 (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.
The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) <40%) and multi-vessel coronary artery disease.
Detailed description
Short background/ Rationale/Aim:
CABG has been shown to prolong survival in patients with reduced left ventricular (LV) function and multi-vessel coronary artery disease and "CABG is recommended as the first revascularization strategy choice in patients with multi-vessel disease and acceptable surgical risk". However, a major concern with CABG is the early risk of complications, including death and stroke. Although PCI has lower rates of peri-procedural complications than CABG in patients without heart failure (HF), this has not been confirmed in patients with HF. The lack of contemporary data comparing CABG and PCI in HF leaves clinicians with no guidance as to which option to choose, and a robust trial is therefore necessary. The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) < 40%) and multi-vessel coronary artery disease.
Study objective:
To test whether PCI is non-inferior to CABG for revascularization of patients with ischemic heart failure.
Study design:
Multicentre, open-label, randomized controlled trial
Study population:
Patients with ischemic cardiomyopathy and reduced ejection fraction.
Number of subjects:
470 subjects
Investigational treatment:
PCI
Treatment in control group:
CABG
Study endpoints:
Primary endpoint (variable):
The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization at 3 years.
Key secondary endpoint The hierarchical occurrence (in descending order of importance) at 3-year follow-up of time to death, time to stroke, time to non-procedural myocardial infarction, number of heart failure hospitalizations and 1-year Kansas City Cardiomyopathy Questionnaire (KCCQ) score; evaluated using the win ratio approach.
Secondary safety endpoints
In-hospital occurrence of the following:
- Death
- Stroke
- Non-procedural myocardial infarction
- The occurrence of in-hospital BARC ≥3 bleeding Time to the occurrence of the following:
- Mediastinitis
- Pericardial tamponade Other secondary endpoints
- Time to the occurrence of the following: A. Death, stroke or non-procedural myocardial infarction B. Death or heart failure hospitalization C. Heart failure hospitalization D. Coronary revascularization E. Death or myocardial infarction F. Death or stroke 2. Total number of days in-hospital during index hospitalization 3. Total number of days in intensive care unit during index hospitalization 4. Quality of life at 30 days and 365 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, multicentre randomized registry trial
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Experimental | Procedure: Percutaneous Coronary Intervention (PCI)Patients will be revascularized by PCI |
| Coronary artery bypass grafting (CABG) | No intervention | –Patients will be revascularized by CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Symptomatic HF defined as NYHA HF class II-IV within 1 month of enrolment
- LVEF ≤ 40% quantified by either echocardiography or gated SPECT ventriculography, or magnetic resonance (MR) or any other recognized assessment of LVEF
- Meaningful amount of myocardium at risk because of CAD (BCIS myocardial jeopardy score ≥ 6 on a recent (> 6 months) coronary angiogram);
- Heart team believes that a meaningful revascularization can be achieved by both PCI or CABG, with complete revascularization defined as residual ischemia in <10% of the left ventricle
Key exclusion criteria (10 listed)
- Previous randomization in the study
- Decompensated heart failure requiring inotropic /adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization
- Recent (<1 month) type 1 myocardial infarction
- Recent PCI (<3 months)
- Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) requiring surgical repair/replacement
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 |
|---|---|---|
| Percutaneous Coronary Intervention (PCI)Alternative treatment | Procedure or surgery | Percutaneous Coronary Intervention (PCI) |
Primary outcome
Major adverse cardiac event
Time frame: 3 years
The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization
5 secondary outcomes
The occurrence of death
Time frame: 3 years
The occurrence of stroke
Time frame: 3 year
The occurrence of non-procedural myocardial infarction,
Time frame: 3 year
The occurrence of heart failure hospitalizations
Time frame: 3 year
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: 1 year
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 13 Oct 2026.
- Derived from this study: PubMed 38112423Thuan PQ, Chuong PTV, Nam NH, Dinh NH. Coronary Artery Bypass Surgery: Evidence-Based Practice. Cardiol Rev. 2025 Jul-Aug 01;33(4):344-351. doi: 10.1097/CRD.0000000000000621. Epub 2023 Dec 19.
- 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.
Björn Redfors, Professor principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention (PCI) in people with Coronary Artery Disease, run by Vastra Gotaland Region at 1 site in Sweden.
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 7 inclusion and 10 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 13 Oct 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 Sweden. 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 Björn Redfors, MD, PhD (+46313427543, Bjoern.Redfors@wlab.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac event (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329285, which also lists 1 linked publication.
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 13 Oct 2026.