Comparing PCI and CABG for heart failure patients with low ejection fraction
CABG or PCI in Patients With Ischemic Cardiomyopathy - A Randomized Registry Clinical Trial
This study is testing whether a less invasive heart procedure called PCI is just as safe and effective as traditional heart surgery, CABG, for patients with heart failure and low heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 470 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT05329285 on ClinicalTrials.gov |
What this trial studies
The STICH-SWEDEHEART trial aims to compare the effectiveness of Percutaneous Coronary Intervention (PCI) versus Coronary Artery Bypass Grafting (CABG) in patients suffering from ischemic cardiomyopathy and reduced left ventricular function. This multicenter, open-label, randomized controlled trial will enroll 470 subjects with multi-vessel coronary artery disease and an ejection fraction of 40% or less. The primary objective is to determine if PCI is non-inferior to CABG in preventing serious complications such as death, stroke, or heart failure hospitalization within three years. The study addresses a critical gap in clinical guidance for treating heart failure patients with significant coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with symptomatic heart failure classified as NYHA class II-IV and an ejection fraction of 40% or less.
Not a fit: Patients who do not have ischemic cardiomyopathy or those with ejection fractions above 40% may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide clearer guidance on the best revascularization strategy for heart failure patients with low ejection fraction, potentially improving patient outcomes.
How similar studies have performed: Previous studies have shown varying results in comparing PCI and CABG, but this specific focus on heart failure patients with low ejection fraction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years. 2. Symptomatic HF defined as NYHA HF class II-IV within 1 month of enrolment 3. LVEF ≤ 40% quantified by either echocardiography or gated SPECT ventriculography, or magnetic resonance (MR) or any other recognized assessment of LVEF 4. Meaningful amount of myocardium at risk because of CAD (BCIS myocardial jeopardy score ≥ 6 on a recent (\> 6 months) coronary angiogram); 5. 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 6. 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 7. Written informed consent obtained Exclusion Criteria: 1. Previous randomization in the study 2. 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 3. Recent (\<1 month) type 1 myocardial infarction 4. Recent PCI (\<3 months) 5. Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) requiring surgical repair/replacement 6. Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy 7. Expected survival less than 3 years due to non-cardiac illness 8. Circumstances likely to lead to poor treatment compliance 9. Individuals for whom record in public health databases is not accessible (non-eligibility to public health system, parallel healthcare systems 10. Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception
Where this trial is running
Gothenburg
- Kardiologen — Gothenburg, Sweden (Recruiting)
Study contacts
- Study coordinator: Björn Redfors, MD, PhD
- Email: Bjoern.Redfors@wlab.gu.se
- Phone: +46313427543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.