Comparing PCI and CABG for heart failure patients with low ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kardiologen
  Gothenburg, Sweden Recruiting

Study contacts

• Principal investigator: Björn Redfors, Professor — Sahlgrenska University Hospital
• Study coordinator: Björn Redfors, MD, PhD
• Email: Bjoern.Redfors@wlab.gu.se
• Phone: +46313427543

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.