The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Recruiting · NCT05427370 · Interventional (participants receive a specific treatment) · Lead sponsor: Sunnybrook Health Sciences Centre
View the official record on ClinicalTrials.gov →Interventions studied
Revascularization by CABGRevascularization by PCI
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age \>18 years;
- LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
- 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;
- 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;
- Signed informed consent.
Exclusion criteria
- 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;
- Recent (\<4 weeks) ST-elevation MI;
- Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
- Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
- Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
- Prior cardiac surgery;
- Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
- Circumstances likely to lead to poor treatment adherence;
- Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years;
- Current pregnancy;
- Patient not amenable to both CABG or PCI according to the Heart Team;
- Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome.
Where it is running
43 locations listed across 6 US states.
- 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
- Hospital del Vinalopó - Alicante, Spain
- Dedinje Cardiovascular Institute - Belgrade, Serbia
- Medical University Bialystok - Bialystok, Poland
- University Hospital Dusseldorf - Düsseldorf, Germany
- Medical University of Silesia - Katowice, Poland
- Leipzig Heart Center - Leipzig, Germany
- Unidade Local de Saude Lisboa Ocidental (ULSLO) - Lisbon, Portugal
- Instituto Mexicano del Seguro Social (IMSS) - Mexico City, Mexico
- Hospital Universitario de Navarra - Pamplona, Spain
- Centro Hospitalar e Universitário Sao João - Porto, Portugal
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine - Shanghai, China
- Heart Institute, Medical School of the University of Sao Paulo_INCOR - São Paulo, Brazil
- Medical University of Vienna - Vienna, Austria
- 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
- Jilin Heart Hospital - Jilin City, Changchun, China
- Hospital Clinic de Barcelona (ICCV) - Barcelona, L'Eixample, Spain
- The University of Manitoba and St. Boniface Hospital Inc. - Winnipeg, Manitoba, Canada
- Hospital Clínico Universitario Virgen de la Arrixaca - El Palmar, Murcia, Spain
- 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
- Al Nas Hospital - Cairo, Qalyubia Governorate, Egypt
- 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
- European Hospital, Via Portuense - Roma, RM, Italy
- G Kuppuswamy Naidu Memorial Hospital (GKNM) - Palayam, Tamil Nadu, India
- Clinical Hospital Dubrava - Sušak, Zagreb, Croatia