The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial
Coronary Artery Disease, Heart Failure Systolic
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Left ventricular dysfunction, CABG, PCI, MACCE
Eligibility Criteria
Inclusion Criteria:
- Age >18 years;
- LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
- 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;
- 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.
Exclusion Criteria:
- 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;
- Recent (<4 weeks) ST-elevation MI;
- Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
- Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
- Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
- Prior cardiac surgery;
- Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
- Circumstances likely to lead to poor treatment adherence;
- Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years;
- Current pregnancy;
- Patient not amenable to both CABG or PCI according to the Heart Team.
- Failure to provide informed consent.
Sites / Locations
- University of Calgary; Libin Cardiovascular InstituteRecruiting
- Fraser Health; Royal Columbian HospitalRecruiting
- London Health Sciences Center, University HospitalRecruiting
- Southlake Regional HCRecruiting
- Sunnybrook Health Sciences CenterRecruiting
- Montreal Heart InstituteRecruiting
- Jilin Heart HospitalRecruiting
- Clinical Hospital DubravaRecruiting
- G Kuppuswamy Naidu Memorial Hospital (GKNM)Recruiting
- European Hospital, Via PortuenseRecruiting
- Hospital del VinalopóRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Revascularization by PCI
Revascularization by CABG
Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter >2.0 mm for PCI. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon.
Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter >1.5 mm for CABG. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon