Recruiting

CABG & PCI

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05427370

Conditions

Coronary Artery Disease

Heart Failure Systolic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Revascularization by PCI

Revascularization by CABG

Study Details

Brief 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.

Conditions

Coronary Artery Disease

Heart Failure Systolic

Study ID

NCT05427370

Start date

Jun 22, 2023

Status verified date

Apr, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

754 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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 >2.0 mm for PCI. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon.

experimental: Revascularization by CABG

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

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.

Primary outcome measure

  • The Primary outcome is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission. [ Time Frame: Median follow-up of 5 years. ]

Central Contacts and Locations

Central contacts

Stephen Fremes, MD,MSc,FRCSC

416-480-6100stephen.fremes@sunnybrook.ca

Reena Karkhanis, MBBS,DA,MSc

416-480-6100reena.karkhanis@sunnybrook.ca

Locations

Cedars-Sinai

Recruiting

Los Angeles, California, United States, 90048

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

UofL Health, Inc

Recruiting

Louisville, Kentucky, United States, 40202

John Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21205

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

University of Calgary; Libin Cardiovascular Institute

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Mackenzie Health Sciences Center

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Providence Health

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

The University of Manitoba and St. Boniface Hospital Inc.

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Queen Elizabeth II Hospital

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

London Health Sciences Center, University Hospital

Recruiting

London, Ontario, Canada, N6A 5A5

Southlake Regional HC

Recruiting

Newmarket, Ontario, Canada, L3Y 2P9

Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Sunnybrook Health Sciences Center

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Stephen Fremes, MD,FRCS(C)

1-416-480-6100

St. Michael's

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Center Hospitalier Universitaire de Montreal

Recruiting

Montreal, Quebec, Canada, , H2X OC1

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Contacts

Gilbert Gosselin

514-376-3330

Hospital Sacre-Coeur

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Institut de Cardiologie Quebec (QC) - Laval

Recruiting

Québec, Quebec, Canada, G1V 4G5

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • Left ventricular dysfunction
  • CABG
  • PCI
  • MACCE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-04-28.