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

COMPLETE-2 STUDY OBJECTIVES

• To determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the efficacy composite outcome of cardiovascular (CV) death, new myocardial infarction (MI) or ischemia-driven revascularization (IDR).
• To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.

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