An interventional study of Revascularization by PCI and Revascularization by CABG in Coronary Artery Disease and Heart Failure Systolic, sponsored by Sunnybrook Health Sciences Centre. Recruiting at 46 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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.
The evidence comparing PCI and CABG with medical therapy in patients with iLVSD has been the subject of multiple systematic reviews/meta-analyses of observational studies with inconsistent results. There is a current lack of evidence from properly powered randomized trials comparing contemporary state-of-the-art PCI vs. CABG to guide the clinical management in the vulnerable population of patients with iLVSD. Understanding the relative impact of both revascularization strategies on clinical outcomes in this prevalent population would have important clinical implications.
The overarching aim of the STICH3C trial is to compare the clinical efficacy and safety of contemporary PCI and CABG to treat patients with multivessel/left main (LM) CAD and iLVSD.
Participants will be allocated in a 1:1 ratio to either study arm using permuted block randomization stratified for study center and acute coronary syndrome (ACS) presentation through a centrally controlled, automated, web system. Eligible patients who provide informed consent can be enrolled. It is expected that initial revascularization will take place within 2 weeks of randomization. Staged PCI is expected to take place within 90 days of randomization. The recruitment will occur over 3 years, with a total study duration of 7 years, and a median duration of follow-up of 5 years.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 754 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter \>2.0 mm for PCI. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon.
Procedure: Revascularization by PCI
Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter \>1.5 mm for CABG. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon
Procedure: Revascularization by CABG
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.
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.
The Primary outcome is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission.
Time to event outcome measured as the time from randomization to the occurence of the first event.
Time frame: Median follow-up of 5 years.
Death
Death will be reported at 30 days. Death over the entire duration of study will be reported as a time to event outcome. Death will be adjudicated as cardiovascular, non-cardiovascular and unknown.
Time frame: At 30 days , 90 days and through study completion with a median follow-up of 5 years.
Myocardial Infarction (MI)
Periprocedural/perioperative MI is defined as \<48 hours from revascularization. Spontaneous MI is defined as \> or = 48 hours post revascularization
Time frame: At 30 days and through study completion with a median follow-up of 5 years.
Number of participants with Stroke
Strokes will be classified as ischemic, hemorrhagic or uncertain.
Time frame: At 30 days , 90 days and through study completion with a median follow-up of 5 years.
Repeat Revascularization (RR)
Only urgent clinically driven unplanned repeat revascularizations by either PCI or CABG count towards primary ouctome. RR will be classified according to type (CABG vs. PCI), by location (target vessel vs. target lesion vs. graft vs. other), and whether clinically vs. non-clinically driven. Stent thrombosis (ARC defined) and graft thrombosis/ occlusion will be reported.
Time frame: At 30 days , 90 days and through study completion with a median follow-up of 5 years.
Hospitalizations
Hospitalizations will be defined as cardiac or non-cardiac. Hospitalizations will be reported as the number of participants with hospitalizations and as a count.
Time frame: Through study completion with a median follow-up of 5 years.
Composite of death/stroke/spontaneous MI
Measured as a time-to-event.
Time frame: Through study completion with a median follow-up of 5 years.
Composite of death/stroke/spontaneous MI/RR
Measured as a time-to-event.
Time frame: Through study completion with a median follow-up of 5 years.
Composite of death or cardiac hospitalization
Measured as a time-to-event.
Time frame: Through study completion with a median follow-up of 5 years.
Coronary composite endpoint
Coronary heart disease death, non-fatal MI, and coronary revascularization procedure. Measured as time-to-event outcome.
Time frame: Through study completion with a median follow-up of 5 years.
Heart Failure endpoint
Heart Failure Event (composite of heart failure death, heart failure hospitalization or revascularization for HF). Measured as time-to-event outcome.
Time frame: Through study completion with a median follow-up of 5 years.
Hierarchal Heart Failure outcome
The key hierarchal outcome of time to death and frequency of HF rehospitalizations will be tested using a win ratio
Time frame: Through study completion with a median follow-up of 5 years.
Number of participants with advanced Heart failure therapies
This includes - ICD/CRT implantation,Mitral valve repair (transcatheter/surgical),Ventricular Assist Device and Heart Transplant
Time frame: Through study completion with a median follow-up of 5 years.
Major Adverse Events
These will be reported as the composite and individually: new renal replacement therapy, major bleeding (Bleeding Academic Research Consortium (BARC) 3-5), major vascular complication (according to VARC-2 criteria), unplanned RR, other reoperation, surgical site complication, intubation \>48 hours, cardiac arrest, advanced cardiac life support, stroke and death.
Time frame: Results will be reported at 30 days and 90 days after index procedure (and 30 days after any planned staged PCI, allowed up to 90 days after randomization) as cardiac surgical hospitalizations maybe prolonged.
Kansas City Cardiomyopathy Questionnaire-12
The scores range from 0-100 with higher scores indicating higher quality of life. The scores are classified as 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time frame: Through study completion with a median follow-up of 5 years.
Seattle Angina Questionnaire-7
It generates a summary score (scale 0-100, 100 = full health, 0 = worst health).
Time frame: Through study completion with a median follow-up of 5 years.
Short Form 12 Questionnaire
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame: Through study completion with a median follow-up of 5 years.
EuroQol-5D (EQ-5D)
Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The EQ-5D index score is anchored at 1 (full health) and 0 (death).
Time frame: Through study completion with a median follow-up of 5 years.
Montreal Cognitive Assessment (MoCA)
Scores on the MoCA range from 0-30; a score of 26 or above is considered normal with higher scores indicating higher cognitive function.
Time frame: Through study completion with a median follow-up of 5 years.
Composite of severe stroke/ventilator dependance/new onset or worsening heart failure/ nursing home admission/ or new onset dialysis
It will be measured as a time to event outcome.
Time frame: Reported at 1 and 5 years and as a cumulative incidence.
Composite of stroke, nursing home admission and 3 or more non-elective admissions per 12 months
It will be measured as a time to event outcome.
Time frame: Reported at 1 and 5 years and as a cumulative incidence.
Length of stay outcomes
Length of stay of index ICU admission, Length of hospital stay of index admission. Days alive and out of hospital (DAOH).
Time frame: Reported at 90 days, 1 year and 5 years - this is only for DAOH.
Cumulative costs
Cumulative costs will be collected over 4 years.
Time frame: 4 years.
Cost-effectiveness
Quality adjusted life years over four years based on EQ-5D at each follow-up time point and four-year cumulative costs.
Time frame: 4 years.
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Started Jun 2023 (actual). Primary completion is estimated for Apr 2029, 70 months after the start.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 70 months is above that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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