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.
Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
Amenable to successful treatment with PCI
At least 50% diameter stenosis by visual estimation
At least 2.5 mm in diameter
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)
Parallel
Physiology-guided NCL PCI
Procedure/SurgeryFor RFR, PCI will be performed as per local practice for all lesions with RFR ≤0.89. For FFR, PCI will be performed as per local practice for all NCLs with FFR ≤0.80.
Angiography-guided NCL PCI
Procedure/SurgeryPCI will be performed as per local practice
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.
Time to first occurrence of the composite of CV death or new MI.
Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.
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