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The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Sponsor: Sunnybrook Health Sciences Centre
Summary
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.
Official title: The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
754
Start Date
2023-06-22
Completion Date
2029-12
Last Updated
2026-01-21
Healthy Volunteers
No
Interventions
Revascularization by PCI
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
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.
Locations (40)
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
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
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
Hospital Sacre-Coeur
Montreal, Quebec, Canada
Institut de Cardiologie Quebec (QC) - Laval
Québec, Quebec, Canada
Jilin Heart Hospital
Jilin, 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
G Kuppuswamy Naidu Memorial Hospital (GKNM)
Palayam, Tamil Nadu, India
European Hospital, Via Portuense
Roma, RM, Italy
Instituto Mexicano del Seguro Social (IMSS)
Mexico City, Mexico
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