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

RecruitingNAAges 18 Years - anyAllSunnybrook Health Sciences Centre
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age \>18 years; 2. LVEF โ‰ค40% 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 โ‰ฅ 70% based on coronary angiography, and/or fractional flow reserve (FFR) โ‰ค0.80 or instantaneous wave-free ratio (iFR) โ‰ค0.89. For LM disease, significant coronary stenosis is defined as \>50% based on coronary angiography, intravascular ultrasound (IVUS) minimal luminal area (MLA) โ‰ค6.0 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 โ‰ฅ1 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.
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What it tests

  • Revascularization by PCI
  • Revascularization by CABG
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Where

46 sites
Cedars-Sinai
Los Angeles, United States
Yale University
New Haven, United States
UofL Health, Inc
Louisville, United States
John Hopkins Hospital
Baltimore, United States
Mayo Clinic
Rochester, United States
University Hospitals Cleveland Medical Center
Cleveland, United States
Medical University of Vienna
Vienna, Austria
Institute of Cardiology
Porto Alegre, Brazil

โ€ฆand 38 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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