Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease (COMPLETE-2)
Acute Myocardial Infarction, Coronary Artery Disease
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring NSTEMI, STEMI, multi-vessel disease, optical coherence tomography, FFR, RFR, percutaneous coronary intervention
Eligibility Criteria
Inclusion Criteria: Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria: Amenable to successful treatment with PCI At least 50% diameter stenosis by visual estimation At least 2.5 mm in diameter Planned complete revascularization strategy for qualifying MI Exclusion Criteria: Planned or prior coronary artery bypass graft (CABG) surgery Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI) Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or >90% visual diameter stenosis Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible) The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism Non-cardiovascular co-morbidity with expected life expectancy <2 years Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up
Sites / Locations
- Hamilton Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Physiology-guided Non-Culprit-Lesion (NCL) PCI
Angiography-guided NCL PCI
Patients randomized to this group will have their physiology assessment using RFR and/or FFR of all qualifying NCLs that were identified prior to randomization. Other validated non-hyperemic physiology ratios (eg. iFR) may only be used when RFR is not available.
Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.