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

NCT05427370 | Recruiting DMC

• 1 other identifier: v.1.6; August 22, 2025
• Study Type: interventional
• Target: 754
• Locations: 15 countries
• Sites: 43

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

Heart Failure Systolic; Coronary Artery Disease

Keywords

Left ventricular dysfunction; CABG; PCI; MACCE

Outcome Measures

Primary Outcomes (1)

• 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.

  Median follow-up of 5 years.

Secondary Outcomes (13)

• Death

  At 30 days , 90 days and through study completion with a median follow-up of 5 years.

• Myocardial Infarction (MI)

  At 30 days and through study completion with a median follow-up of 5 years.

• Number of participants with Stroke

  At 30 days , 90 days and through study completion with a median follow-up of 5 years.

• Repeat Revascularization (RR)

  At 30 days , 90 days and through study completion with a median follow-up of 5 years.

• Hospitalizations

  Through study completion with a median follow-up of 5 years.

Other Outcomes (10)

• Kansas City Cardiomyopathy Questionnaire-12

  Through study completion with a median follow-up of 5 years.

• Seattle Angina Questionnaire-7

  Through study completion with a median follow-up of 5 years.

• Short Form 12 Questionnaire

  Through study completion with a median follow-up of 5 years.

Study Arms (2)

Revascularization by PCI

EXPERIMENTAL

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 by CABG

EXPERIMENTAL

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

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 PCI

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.

Revascularization by CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (43)

Cedars-Sinai

Los Angeles, California, 90048, United States

RECRUITING

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

UofL Health, Inc

Louisville, Kentucky, 40202, United States

RECRUITING

John Hopkins Hospital

Baltimore, Maryland, 21205, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

WITHDRAWN

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Medical University of Vienna

Vienna, Austria

ACTIVE NOT RECRUITING

Heart Institute, Medical School of the University of Sao Paulo_INCOR

São Paulo, 05403-900, Brazil

RECRUITING

University of Calgary; Libin Cardiovascular Institute

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Mackenzie Health Sciences Center

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Fraser Health; Royal Columbian Hospital

New Westminster, British Columbia, V3L3W7, Canada

WITHDRAWN

Providence Health

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

The University of Manitoba and St. Boniface Hospital Inc.

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

Queen Elizabeth II Hospital

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

London Health Sciences Center, University Hospital

London, Ontario, N6A 5A5, Canada

RECRUITING

Southlake Regional HC

Newmarket, Ontario, L3Y 2P9, Canada

RECRUITING

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

Center Hospitalier Universitaire de Montreal

Montreal, Quebec, , H2X OC1, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Hospital Sacre-Coeur

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

Institut de Cardiologie Quebec (QC) - Laval

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Jilin Heart Hospital

Jilin, Changchun, 130117, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200031, China

RECRUITING

Clinical Hospital Dubrava

Sušak, Zagreb, 10000, Croatia

RECRUITING

Al Nas Hospital

Cairo, Qalyubia Governorate, Egypt

RECRUITING

University Hospital Dusseldorf

Düsseldorf, 40225, Germany

RECRUITING

Leipzig Heart Center

Leipzig, 04289, Germany

RECRUITING

G Kuppuswamy Naidu Memorial Hospital (GKNM)

Palayam, Tamil Nadu, 641037, India

RECRUITING

European Hospital, Via Portuense

Roma, RM, 00149, Italy

RECRUITING

Instituto Mexicano del Seguro Social (IMSS)

Mexico City, Mexico

RECRUITING

Medical University Bialystok

Bialystok, 15-089, Poland

RECRUITING

Medical University of Silesia

Katowice, Poland

ACTIVE NOT RECRUITING

Unidade Local de Saude Lisboa Ocidental (ULSLO)

Lisbon, 1350-410, Portugal

RECRUITING

Centro Hospitalar e Universitário Sao João

Porto, 4200-319, Portugal

RECRUITING

Dedinje Cardiovascular Institute

Belgrade, Serbia

RECRUITING

Hospital Clinic de Barcelona (ICCV)

Barcelona, L'Eixample, 08036, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Hospital del Vinalopó

Alicante, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, 31008, Spain

RECRUITING

Related Publications (1)

• Fremes SE, Marquis-Gravel G, Gaudino MFL, Jolicoeur EM, Bedard S, Masterson Creber R, Ruel M, Vervoort D, Wijeysundera HC, Farkouh ME, Rouleau JL; STICH3C Study Investigators. STICH3C: Rationale and Study Protocol. Circ Cardiovasc Interv. 2023 Aug;16(8):e012527. doi: 10.1161/CIRCINTERVENTIONS.122.012527. Epub 2023 Aug 15.

  PMID: 37582169 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure, Systolic; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Failure; Ventricular Dysfunction

Study Officials

• Stephen Fremes, MD,MSc,FRCSC

  Sunnybrook Health Sciences Center, Toronto, Canada

  PRINCIPAL INVESTIGATOR

• Mario Gaudino, MD,PhD

  Weill Medical College of Cornell University, USA

  PRINCIPAL INVESTIGATOR

• Jean L Rouleau, MD,PhD

  Montreal Heart Institute, QC Canada

  PRINCIPAL INVESTIGATOR

• Guillaume Maquis-Gravel, MD,MSc

  Montreal Heart Institute, QC Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Fremes, MD,MSc,FRCSC

CONTACT

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

Reena Karkhanis, MBBS,DA,MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, University of Toronto

Model Details: The STICH3C trial is a prospective, unblinded, international multi-center randomized trial of comparing revascularization by PCI vs. CABG in patients with multivessel/LM CAD and reduced LVEF.

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 22, 2022
• Study Start: June 22, 2023
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

EG (1); AU (1); SE (1); IT (1); IN (1); PL (2); US (6); ES (4); CN (2); CA (17); CR (1); PT (2); DE (2); ME (1); BR (1)