Comparing CABG and PCI for severe coronary artery disease and heart failure
The CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH) 3.0 International Trial Consortium
NA · Vastra Gotaland Region · NCT05761067
This study is testing whether heart surgery or a less invasive procedure is better at helping people with severe heart disease and heart failure live longer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region (other gov) |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT05761067 on ClinicalTrials.gov |
What this trial studies
The STICH 3.0 study aims to determine if coronary artery bypass grafting (CABG) is more effective than percutaneous coronary intervention (PCI) in reducing all-cause mortality over five years in patients with severe coronary artery disease and impaired left ventricular systolic function. This study will pool and analyze individual patient data from various national randomized controlled trials to provide a comprehensive comparison of these two treatment methods. The primary focus is on long-term outcomes, particularly mortality rates, to address existing inconsistencies in observational studies regarding these interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a left ventricular ejection fraction of 40% or less and extensive coronary artery disease.
Not a fit: Patients with decompensated heart failure requiring intensive support, significant valvular heart disease, or those at high risk for bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective treatment for patients with severe coronary artery disease and heart failure, potentially improving survival rates.
How similar studies have performed: Previous studies have indicated that CABG may offer better long-term outcomes compared to PCI, but this specific comparison in a randomized controlled setting is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * LVEF ≤40% * Extensive coronary artery disease (typically defined as a British Cardiovascular Intervention Society jeopardy score of ≥6, on a scale from 0 to 12, with higher scores indicating greater extent of disease). Exclusion Criteria: * 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; * Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) indicating the need for surgical repair/replacement; * Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy; * Pregnancy; * Circumstances likely to lead to poor treatment adherence; * STEMI within 72 hours; * PCI within 3 months.
Where this trial is running
Gothenburg
- Dep of Cardiology, Sahlgrenska University Hospital — Gothenburg, Sweden (RECRUITING)
Study contacts
- Study coordinator: Björn Redfors, MD, PhD
- Email: bjorn.redfors@wlab.gu.se
- Phone: +46 313421000
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.
Conditions: Coronary Artery Disease, Heart Failure, PCI, CABG