What is the Purpose of this Study?
The overall objective is to compare the clinical efficacy and safety of contemporary PCI and CABG to treat patients with multivessel/LM CAD and iLVSD. Primary objective: 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 iLVSD. Secondary objectives: To describe the early risks and clinical outcomes of both procedures, and to describe a comprehensive set of patient-reported outcomes longitudinally. Tertiary objective: To contribute to a collaborative effort to determine, in aggregate, whether PCI is non-inferior to CABG in terms of mortality over similar follow-up. The primary and secondary objectives will be directly answered by the STICH3C protocol. STICH3C is embedded in an international collaborative of independently funded yet harmonized randomized trials in similar patient populations.
Eligibility
- 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;
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
The Canadian CABG or PCI in Patients with Ischemic Cardiomyopathy Trial