Status:
RECRUITING
CABG or PCI in Patients With Ischemic Cardiomyopathy
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Region Örebro County
Karolinska University Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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.
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2052
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT05329285
Start Date
September 14 2022
End Date
December 31 2052
Last Update
June 24 2024
Active Locations (1)
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1
Kardiologen
Gothenburg, Sweden, 41345