CABG or PCI in Patients With Ischemic Cardiomyopathy
STICH
1 other identifier
interventional
470
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Sep 2022
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedStudy Start
First participant enrolled
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2052
June 24, 2024
May 1, 2024
6.3 years
March 17, 2022
June 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major adverse cardiac event
The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization
3 years
Secondary Outcomes (5)
The occurrence of death
3 years
The occurrence of stroke
3 year
The occurrence of non-procedural myocardial infarction,
3 year
The occurrence of heart failure hospitalizations
3 year
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
1 year
Study Arms (2)
Percutaneous Coronary Intervention (PCI)
EXPERIMENTALPatients will be revascularized by PCI
Coronary artery bypass grafting (CABG)
NO INTERVENTIONPatients will be revascularized by CABG
Interventions
Alternative treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vastra Gotaland Regionlead
- Region Örebro Countycollaborator
- Karolinska University Hospitalcollaborator
- University Hospital, Umeåcollaborator
Study Sites (1)
Kardiologen
Gothenburg, 41345, Sweden
Related Publications (1)
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.
PMID: 38112423DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2022
First Posted
April 15, 2022
Study Start
September 14, 2022
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2052
Last Updated
June 24, 2024
Record last verified: 2024-05