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

Coronary Artery Disease | Heart Failure Systolic

The 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 Hospital
New Westminster, British Columbia
Canada

Contact Study Team

Primary Contact

Daniel Wong

London Health Sciences Center, University Hospital
London Health Sciences Center, University Hospital
London, Ontario
Canada

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Primary Contact

David Nagpal

St. Michael's
St. Michael's
Toronto, Ontario
Canada

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Primary Contact

Akshay Bagai

Jewish General Hospital
Jewish General Hospital
Montréal, Quebec
Canada

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Primary Contact

Emmanuel Moss

Mackenzie Health Sciences Center
Mackenzie Health Sciences Center
Edmonton, Alberta
Canada

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Primary Contact

Jayan Nagendran

Hamilton General Hospital
Hamilton General Hospital
Hamilton, Ontario
Canada

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Sunnybrook Health Sciences Center
Sunnybrook Health Sciences Center
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Stephen Fremes, MD,FRCS(C)

1-416-480-6100
Montreal Heart Institute
Montreal Heart Institute
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Gilbert Gosselin

514-376-3330
Providence Health
Providence Health
Vancouver, British Columbia
Canada

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Primary Contact

James Abel

Toronto General Hospital
Toronto General Hospital
Toronto, Ontario
Canada

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Primary Contact

Vivek Rao

Southlake Regional HC
Southlake Regional HC
Newmarket, Ontario
Canada

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Primary Contact

Liane Porepa

Hospital Sacre-Coeur
Hospital Sacre-Coeur
Montréal, Quebec
Canada

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Primary Contact

Erick Schampaert

University of Calgary; Libin Cardiovascular Institute
University of Calgary; Libin Cardiovascular Institute
Calgary, Alberta
Canada

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Primary Contact

Robert Miller

Queen Elizabeth II Hospital
Queen Elizabeth II Hospital
Halifax, Nova Scotia
Canada

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Primary Contact

Kim Anderson

Ottawa Heart Institute
Ottawa Heart Institute
Ottawa, Ontario
Canada

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Primary Contact

Marc Ruel

Center Hospitalier Universitaire de Montreal
Center Hospitalier Universitaire de Montreal
Montréal, Quebec
Canada

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Primary Contact

Samer Mansour

Institut de Cardiologie Quebec (QC) - Laval
Institut de Cardiologie Quebec (QC) - Laval
Québec, Quebec
Canada

Contact Study Team

Primary Contact

Dimitri Kalavrouziotis

Study Sponsored By
Sunnybrook Health Sciences Centre
Participants Required
More Information
Study ID: NCT05427370