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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Myocardial Infarction, Coronary Artery Disease

Intervention / Treatment
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* Procedure: Physiology-guided NCL PCI
* Procedure: Angiography-guided NCL PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physiology-guided Non-Culprit-Lesion (NCL) PCI<br>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. | Procedure: Physiology-guided NCL PCI<br>* 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.<br>|
| Other: Angiography-guided NCL PCI<br>Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization. | Procedure: Angiography-guided NCL PCI<br>* PCI will be performed as per local practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR |  | at study completion, a minimum of 2 years | 
| Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury. |  | at study completion, a minimum of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of the composite of CV death or new MI. |  | at study completion, a minimum of 2 years | 
| 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. |  | at study completion, a minimum of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSTEMI, STEMI, multi-vessel disease, optical coherence tomography, FFR, RFR, percutaneous coronary intervention