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STICH3C: Rationale and Study Protocol
Stephen E Fremes1, Guillaume Marquis-Gravel2, Mario F L Gaudino3
1Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada (S.E.F., D.V., H.C.W.).
Insights
The STICH3C trial compares coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) for patients with ischemic left ventricular dysfunction and multivessel disease. Results will guide treatment decisions for severe coronary artery disease.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Cardiac Surgery
Background:
- Coronary artery bypass grafting (CABG) is recommended for ischemic left ventricular dysfunction (iLVSD) with multivessel disease.
- Percutaneous coronary intervention (PCI) use is increasing in this population due to technological advancements.
- Limited randomized trial data exists comparing contemporary PCI and CABG for iLVSD.
Purpose of the Study:
- To compare the efficacy and safety of state-of-the-art PCI versus CABG in patients with iLVSD and multivessel coronary artery disease.
- To provide evidence for clinical practice and guideline development.
- To assess clinical events, health status, and economic outcomes.
Main Methods:
- Prospective, unblinded, international, multicenter trial (STICH3C).
- Randomization of 754 patients with iLVSD (LVEF ≤40%) and multivessel/left main disease to PCI or CABG (1:1 ratio).
- Primary endpoint: composite of death, stroke, myocardial infarction, urgent revascularization, or heart failure readmission.
Main Results:
- Primary endpoint data collection is ongoing.
- Key hierarchical endpoint: time to death and heart failure hospitalizations.
- Key safety outcome: composite of major adverse events.
Conclusions:
- STICH3C trial results will inform patient care, clinical practice, and international guidelines.
- The study will offer novel evidence on CABG vs. PCI for iLVSD.
- Findings will guide management of iLVSD with severe coronary artery disease.
Background:
Coronary artery bypass grafting (CABG) is the recommended mode of revascularization in patients with ischemic left ventricular dysfunction (iLVSD) and multivessel disease. However, contemporary percutaneous coronary intervention (PCI) outcomes have improved with the integration of novel technologies and refinement of revascularization strategies, and PCI is often used in clinical practice in this population. There is a lack of evidence from randomized trials comparing contemporary state-of-the-art PCI versus CABG for the treatment of iLVSD and multivessel disease. This was the impetus for the STICH3C trial (Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy), described here.
Methods:
The STICH3C trial is a prospective, unblinded, international, multicenter trial with an expected sample size of 754 participants from ≈45 centers. Patients with multivessel/left main coronary artery disease and iLVSD with left ventricular ejection fraction ≤40% considered by the local Heart Team appropriate for and amenable to revascularization by both modes of revascularization will be randomized in a 1:1 ratio to state-of-the-art PCI or CABG.
Results:
The primary end point is the composite of death from any cause, stroke, spontaneous myocardial infarction, urgent repeat revascularization, or heart failure readmission, summarized as a time-to-event outcome. The key hierarchical end point is time to death and frequency of hospitalizations for heart failure. The key safety outcome is a composite of major adverse events. Disease-specific quality-of-life and health economics measures will be compared between groups. Participants will be followed for a median of 5 years, with a minimum follow-up of 4 years.
Conclusions:
STICH3C will directly inform patients, clinicians, and international practice guidelines about the efficacy and safety of CABG versus PCI in patients with iLVSD. The results will provide novel and broad evidence, including clinical events, health status, and economic assessments, to guide care for patients with iLVSD and severe coronary artery disease.
Registration:
URL: https://clinicaltrials.gov/; Unique identifier: NCT05427370.
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