Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

Study Overview
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Brief Summary
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The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR > 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (MI), target-vessel revascularization (TVR), and hospitalization for unstable or progressive angina at 2 years, when compared with OMT alone.

Detailed Description
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Sub-analysis for each imaging test will be performed as below; NIRS(Near-infrared spectroscopy) OCT(Optical coherence tomography) VH-IVUS(IVUS-derived virtual histology) IVUS(Intravascular ultrasonography) Extended follow-up: Considering the nature of functionally insignificant coronary stenosis with vulnerable plaque, most subjects are watched for extended follow-up after the planned 2-year follow-up time point.

Official Title
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a Multinational, Multicenter, Prospective, Open-label, Active-treatment-controlled Randomized Trial: Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque_PREVENT Trial

Conditions
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Coronary Artery Disease, Plaque, Atherosclerotic

Intervention / Treatment
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* Device: Coronary intervention
* Drug: Optimal Medical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥18 years Patients with suspected or known Coronary artery disease who are undergoing invasive cardiac catheterization Patients with at least one significant stenosis (diameter stenosis >50%) with Fractional Flow Reserve (FFR) >0.80 and meeting two of the following criteria: MLA(minimal luminal area)<4mm2 Plaque burden>70% Large lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy), defined as MaxLCBI4mm>315 TCFA(thin-cap fibroatheroma) defined as fibrous cap thickness <65 μm and arc >90° on optical coherence tomography (OCT) or ≥10% confluent necrotic core with >30° abutting the lumen in three consecutive slices on Virtual-histology intravascular ultrasound (VH-IVUS) Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular Scaffold or Everolimus Eluting Stent Reference vessel diameter 2.75-4.0 Lesion length ≤ 40mm Willing and able to provide informed written consent Exclusion Criteria: Patients for whom the preferred treatment is CABG(Coronary artery bypass grafting) Patients with stented lesions Patients with bypass graft lesions Patients with three or more target lesions Patients with two target lesions in the same coronary territory Patients with heavily calcified or angulated lesions Patients with bifurcation lesions requiring 2 stenting technique Patients with contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year Patients with life expectancy <2 years Patients with planned cardiac or major noncardiac surgery Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coronary intervention<br>bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) +Optimal Medical Treatment | Device: Coronary intervention<br>* bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment<br>|
| Active Comparator: Optimal Medical Treatment<br>Optimal Medical Treatment | Drug: Optimal Medical treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure | target-vessel failure, which was defined a composite of death from cardiac causes, target-vessel myocardial infarction, ischemic-driven target-vessel revascularization, or hospitalization for unstable or progressive angina | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from cardiac causes |  | 2 years | 
| Target-vessel myocardial infarction |  | 2 years | 
| Ischemic-driven target-vessel revascularization |  | 2 years | 
| Hospitalization for unstable or progressive angina |  | 2 years | 
| Death from all, cardiac, or noncardiac causes |  | 2 years | 
| Myocardial infarction | Periprocedural or spontaneous, target-vessel or non-target-vessel related | 2 years | 
| Repeat revascularization | Repeat revascularization (target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven) | 2 years | 
| Any hospitalization for cardiac or noncardiac causes |  | 2 years | 
| Target-lesion failure | cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization | 2 years | 
| Major adverse cardiac event | defined as death from cardiovascular causes, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina | 2 years | 
| Composite of any death, myocardial infarction, or repeat revascularization | A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed. | 2 years | 
| Rate of Scaffold or stent thrombosis |  | 2 years | 
| Rate of Stroke |  | 2 years | 
| Rate of Bleeding events | life-threatening or disabling, major or minor | 2 years | 
| Rate of Nonurgent revascularization procedures |  | 2 years | 
| Functional class | It is assessed by the Canadian Cardiovascular Society (CCS) Classification at each point in time. The Canadian Cardiovascular Society (CCS) classification has four categories; the minimum and maximum values are 1 and 4 respectively. A higher score means a worse outcome. | 2 years | 
| Number of anti-anginal medications administered | Number of anti-anginal medication at each point in time | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary intervention, Vulnerable Plaque, Insignificant Stenosis, Bioresorbable Vascular Scaffold, Everolimus Eluting stent