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

Last updated: February 27, 2025
Sponsor: Sunnybrook Health Sciences Centre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Thrombosis

Atherosclerosis

Treatment

Revascularization by CABG

Revascularization by PCI

Clinical Study ID

NCT05427370
v.1.5; July 2, 2024
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age >18 years;

  2. LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magneticresonance within 2 months of randomization;

  3. Prognostically important multivessel CAD (triple vessel CAD or double vessel diseaseincluding the left anterior descending (LAD) or LM). Significant coronary stenosisis 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 Asiandescent), 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 patientshospitalized 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 betitrated to maximally tolerated doses after revascularization;

  5. Signed informed consent.

Exclusion

Exclusion Criteria:

  1. Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasiveventilation 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 ventricularaneurysm requiring surgical repair or replacement;

  4. Planned major concomitant surgical procedures (LAAO and AF ablation surgicalprocedures permitted);

  5. Prior PCI within the past 12 months (to reduce restenosis events from prior PCIscontributing 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

Total Participants: 754
Treatment Group(s): 2
Primary Treatment: Revascularization by CABG
Phase:
Study Start date:
June 22, 2023
Estimated Completion Date:
December 31, 2029

Study Description

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.

Connect with a study center

  • Medical University of Vienna

    Vienna,
    Austria

    Active - Recruiting

  • Institute of Cardiology

    Porto Alegre, 90610-001
    Brazil

    Active - Recruiting

  • Heart Institute, Medical School of the University of Sao Paulo_INCOR

    São Paulo, 05403-900
    Brazil

    Active - Recruiting

  • University of Calgary; Libin Cardiovascular Institute

    Calgary, Alberta T2N 4Z6
    Canada

    Active - Recruiting

  • Mackenzie Health Sciences Center

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • Fraser Health; Royal Columbian Hospital

    New Westminster, British Columbia V3L3W7
    Canada

    Active - Recruiting

  • Providence Health

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Active - Recruiting

  • Queen Elizabeth II Hospital

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • London Health Sciences Center, University Hospital

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • Southlake Regional HC

    Newmarket, Ontario L3Y 2P9
    Canada

    Active - Recruiting

  • Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Active - Recruiting

  • St. Michael's

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Center

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • Toronto General Hospital

    Toronto, Ontario M5G 2N2
    Canada

    Active - Recruiting

  • Center Hospitalier Universitaire de Montreal

    Montréal, Quebec , H2X OC1
    Canada

    Active - Recruiting

  • Hospital Sacre-Coeur

    Montréal, Quebec H4J 1C5
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montréal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Montreal Heart Institute

    Montréal, Quebec H1T 1C8
    Canada

    Active - Recruiting

  • Institut de Cardiologie Quebec (QC) - Laval

    Québec, Quebec G1V 4G5
    Canada

    Active - Recruiting

  • Jilin Heart Hospital

    Jilin, Changchun 130117
    China

    Active - Recruiting

  • Clinical Hospital Dubrava

    Sušak, Zagreb 10000
    Croatia

    Active - Recruiting

  • University Hospital Dusseldorf

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • G Kuppuswamy Naidu Memorial Hospital (GKNM)

    Palayam, Tamil Nadu 641037
    India

    Active - Recruiting

  • European Hospital, Via Portuense

    Roma, RM 00149
    Italy

    Active - Recruiting

  • Instituto Mexicano del Seguro Social (IMSS)

    Ciudad de México,
    Mexico

    Active - Recruiting

  • Medical University of Silesia

    Katowice,
    Poland

    Active - Recruiting

  • Unidade Local de Saude Lisboa Ocidental (ULSLO)

    Lisboa, 1350-410
    Portugal

    Active - Recruiting

  • Dedinje Cardiovascular Institute

    Belgrade,
    Serbia

    Active - Recruiting

  • Hospital Clinic de Barcelona (ICCV)

    Barcelona, L'Eixample 08036
    Spain

    Active - Recruiting

  • Hospital del Vinalopó

    Alicante,
    Spain

    Active - Recruiting

  • Hospital Universitario de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Cedars-Sinai

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • UofL Health, Inc

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

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