Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
A Randomized Trial of Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization Strategies & an Observational Study of Optical Coherence Tomography in Patients With Acute MI & Multivessel Coronary Artery Disease
Population Health Research Institute
5,100 participants
Jun 22, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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
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Interventions
For 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.
PCI will be performed as per local practice
Locations(113)
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NCT05701358