The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Coronary Artery Disease | Heart Failure SystolicThe Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH3C) trial is a prospective, unblinded, international multi-center randomized trial of 754 subjects enrolled in approximately 45 centers comparing revascularization by percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) in patients with multivessel/left main (LM) coronary artery disease (CAD) and reduced left ventricular ejection fraction (LVEF).
The primary objective is to determine whether CABG compared to PCI is associated with a reduction in all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in patients with multivessel/LM CAD and ischemic left ventricular dysfunction (iLVSD).
Eligible patients are considered by the local Heart Team appropriate and amenable for non-emergent revascularization by both modes of revascularization.
The secondary objectives are to describe the early risks of both procedures, and a comprehensive set of patient-reported outcomes longitudinally.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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.
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;
13. Failure to provide informed consent.
Study Location
Fraser Health; Royal Columbian Hospital
Fraser Health; Royal Columbian HospitalNew Westminster, British Columbia
Canada
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Daniel Wong
London Health Sciences Center, University Hospital
London Health Sciences Center, University HospitalLondon, Ontario
Canada
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David Nagpal
St. Michael's
St. Michael'sToronto, Ontario
Canada
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Akshay Bagai
Jewish General Hospital
Jewish General HospitalMontréal, Quebec
Canada
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Emmanuel Moss
Mackenzie Health Sciences Center
Mackenzie Health Sciences CenterEdmonton, Alberta
Canada
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Jayan Nagendran
Hamilton General Hospital
Hamilton General HospitalHamilton, Ontario
Canada
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Sunnybrook Health Sciences Center
Sunnybrook Health Sciences CenterToronto, Ontario
Canada
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Stephen Fremes, MD,FRCS(C)
1-416-480-6100Montreal Heart Institute
Montreal Heart InstituteMontréal, Quebec
Canada
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Gilbert Gosselin
514-376-3330Providence Health
Providence HealthVancouver, British Columbia
Canada
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James Abel
Toronto General Hospital
Toronto General HospitalToronto, Ontario
Canada
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Vivek Rao
Southlake Regional HC
Southlake Regional HCNewmarket, Ontario
Canada
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Liane Porepa
Hospital Sacre-Coeur
Hospital Sacre-CoeurMontréal, Quebec
Canada
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Erick Schampaert
University of Calgary; Libin Cardiovascular Institute
University of Calgary; Libin Cardiovascular InstituteCalgary, Alberta
Canada
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Robert Miller
Queen Elizabeth II Hospital
Queen Elizabeth II HospitalHalifax, Nova Scotia
Canada
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Kim Anderson
Ottawa Heart Institute
Ottawa Heart InstituteOttawa, Ontario
Canada
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Marc Ruel
Center Hospitalier Universitaire de Montreal
Center Hospitalier Universitaire de MontrealMontréal, Quebec
Canada
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Samer Mansour
Institut de Cardiologie Quebec (QC) - Laval
Institut de Cardiologie Quebec (QC) - LavalQuébec, Quebec
Canada
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Dimitri Kalavrouziotis
- Study Sponsored By
- Sunnybrook Health Sciences Centre
- Participants Required
- More Information
- Study ID:
NCT05427370