The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Jun 16, 2022

Keywords

ClinConnect Summary

The STICH3C trial is studying two different heart procedures—coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)—to see which one is better for patients with severe coronary artery disease and heart failure. The goal is to find out if one procedure helps patients live longer and have fewer heart-related problems compared to the other. This trial involves about 754 participants from around 45 medical centers and will follow them for about 5 years to gather important information on their health outcomes.

To be eligible for this trial, participants need to be at least 18 years old and have a weakened heart function, indicated by a measurement called left ventricular ejection fraction (LVEF) of 40% or less. They should also have significant heart artery blockages that can be treated with either procedure. Participants will receive standard medical treatment and will be closely monitored for any risks or side effects from the procedures. This study aims not only to compare the effectiveness of the two methods but also to gather information on patients’ experiences and quality of life over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>18 years;
• • 2. LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
• • 3. Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant coronary stenosis is defined as ≥ 70% based on coronary angiography, and/or fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. For LM disease, significant coronary stenosis is defined as \>50% based on coronary angiography, intravascular ultrasound (IVUS) minimal luminal area (MLA) ≤6.0 mm2 (\<4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements;
• • 4. The institutional 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;
• • 5. Signed informed consent.
• Exclusion Criteria:
• • 1. Decompensated HF 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;
• • 2. Recent (\<4 weeks) ST-elevation MI;
• • 3. Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
• • 4. Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
• • 5. Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
• • 6. Prior cardiac surgery;
• • 7. Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
• • 8. Circumstances likely to lead to poor treatment adherence;
• • 9. Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years;
• • 10. Current pregnancy;
• • 11. Patient not amenable to both CABG or PCI according to the Heart Team;
• • 12. Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome.