RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Sunnybrook Health Sciences Centre • ClinicalTrials.gov ID: NCT05427370

Registry updated: 2026-10-19

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Description

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.

Interventions

Revascularization by PCI (Procedure)
Contemporary, "State-of-the-art" PCI techniques will be encouraged in STICH3C, based on the most recent evidence and clinical practice guidelines recommendations. The best practices to be followed include the use of physiological and intravascular guidance, new-generation drug-eluting stents or scaffolds, rotational or orbital atherectomy for extensive calcifications, recommended bifurcation techniques, chronic total occlusion for viable segments by experienced operators, and trans-radial access.Planned temporary ventricular support is permitted by experienced operators when deemed indicated.
Revascularization by CABG (Procedure)
The surgical revascularization strategy will be tailored according to the individual patient's coronary anatomy, left ventricular remodeling, aortic atherosclerosis, co-morbidities, local expertise, and surgical judgement. An internal thoracic artery will be used to graft the left anterior descending in all cases. Multi-arterial grafting may be considered in patients without significant co-morbidities and with expected limited vasopressor use, or in patients without saphenous conduits. Choice of on- vs. off-pump surgery is influenced by LV size, associated valvular disease, and aortic atherosclerosis, as well as surgeon experience, but on-pump surgery is recommended routinely. The use of adjunctive intra-aortic balloon support or other cardiac support is not routinely recommended in stable patients; the intra-aortic balloon support is the first line mechanical support.

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.

Conditions

Coronary Artery Disease Heart Failure Systolic

Locations

Cedars-Sinai — Los Angeles, California, United States
Yale University — New Haven, Connecticut, United States
UofL Health, Inc — Louisville, Kentucky, United States
John Hopkins Hospital — Baltimore, Maryland, United States
Mayo Clinic — Rochester, Minnesota, United States
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
Medical University of Vienna — Vienna, Austria
Institute of Cardiology — Porto Alegre, Brazil
Heart Institute, Medical School of the University of Sao Paulo_INCOR — São Paulo, Brazil
University of Calgary; Libin Cardiovascular Institute — Calgary, Alberta, Canada
Mackenzie Health Sciences Center — Edmonton, Alberta, Canada
Fraser Health; Royal Columbian Hospital — New Westminster, British Columbia, Canada
Providence Health — Vancouver, British Columbia, Canada
The University of Manitoba and St. Boniface Hospital Inc. — Winnipeg, Manitoba, Canada
Queen Elizabeth II Hospital — Halifax, Nova Scotia, Canada
Hamilton General Hospital — Hamilton, Ontario, Canada
London Health Sciences Center, University Hospital — London, Ontario, Canada
Southlake Regional HC — Newmarket, Ontario, Canada
Ottawa Heart Institute — Ottawa, Ontario, Canada
Sunnybrook Health Sciences Center — Toronto, Ontario, Canada
St. Michael's — Toronto, Ontario, Canada
Toronto General Hospital — Toronto, Ontario, Canada
Center Hospitalier Universitaire de Montreal — Montreal, Quebec, Canada
Montreal Heart Institute — Montreal, Quebec, Canada
Jewish General Hospital — Montreal, Quebec, Canada
Hospital Sacre-Coeur — Montreal, Quebec, Canada
Institut de Cardiologie Quebec (QC) - Laval — Québec, Quebec, Canada
Jilin Heart Hospital — Jilin City, Changchun, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China
Clinical Hospital Dubrava — Sušak, Zagreb, Croatia
Al Nas Hospital — Cairo, Qalyubia Governorate, Egypt
University Hospital Dusseldorf — Düsseldorf, Germany
Leipzig Heart Center — Leipzig, Germany
G Kuppuswamy Naidu Memorial Hospital (GKNM) — Palayam, Tamil Nadu, India
European Hospital, Via Portuense — Roma, RM, Italy
Pauls Stradins Clinical University Hospital — Riga, Latvia
Instituto Mexicano del Seguro Social (IMSS) — Mexico City, Mexico
Medical University Bialystok — Bialystok, Poland
Medical University of Silesia — Katowice, Poland
Unidade Local de Saude Lisboa Ocidental (ULSLO) — Lisbon, Portugal
Centro Hospitalar e Universitário Sao João — Porto, Portugal
Dedinje Cardiovascular Institute — Belgrade, Serbia
Hospital Clinic de Barcelona (ICCV) — Barcelona, L'Eixample, Spain
Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain
Hospital del Vinalopó — Alicante, Spain
Hospital Universitario de Navarra — Pamplona, Spain

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