Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI).COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

Inclusion Criteria:Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCIResidual 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 PCIAt least 50% diameter stenosis by visual estimationAt least 2.5 mm in diameterPlanned complete revascularization strategy for qualifying MIExclusion Criteria:Planned or prior coronary artery bypass graft (CABG) surgeryInability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalitiesPrior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomizationPlanned 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 stenosisPresence 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 lesionBaseline 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 embolismNon-cardiovascular co-morbidity with expected life expectancy <2 yearsAny other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up