What is the Purpose of this Study?
This study focuses on people who have multivessel coronary artery disease (blockages in the blood vessels supplying the heart muscle) and ischemic left ventricular dysfunction (weak heart from reduced coronary blood flow secondary to the blockages), requiring intervention to improve the blood flow to the heart. The purpose of the study is to evaluate and compare the effectiveness of percutaneous coronary intervention (PCI) against coronary artery bypass grafting (CABG) in these patients. Both procedures are approved by the U.S. Food and Drug Administration (FDA) as standard of care for patients with multivessel CAD and iLVSD. Researchers aim to determine whether one method is better than the other. PCI is a cath lab procedure in which the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. CABG is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to “bypass” the blockages, like a detour. Participants will be randomly assigned to receive either PCI or CABG. (If the heart team believes that 1 of the 2 procedures serves the patient’s clinical needs better, they will not be randomly assigned to a study group and will receive the procedure that the heart team prefers.)
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