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

Description

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 Overview

Study Details

Study overview

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 Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial

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

Condition
Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai, Los Angeles, California, United States, 90048

Louisville

UofL Health, Inc, Louisville, Kentucky, United States, 40202

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Cleveland

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States, 44106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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;
  • 13. Failure to provide informed consent.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sunnybrook Health Sciences Centre,

Stephen Fremes, MD,MSc,FRCSC, PRINCIPAL_INVESTIGATOR, Sunnybrook Health Sciences Center, Toronto, Canada

Mario Gaudino, MD,PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University, USA

Jean L Rouleau, MD,PhD, PRINCIPAL_INVESTIGATOR, Montreal Heart Institute, QC Canada

Guillaume Maquis-Gravel, MD,MSc, PRINCIPAL_INVESTIGATOR, Montreal Heart Institute, QC Canada

Study Record Dates

2029-12