Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque (PREVENT)

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

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.

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.

coronary intervention, Vulnerable Plaque, Insignificant Stenosis, Bioresorbable Vascular Scaffold, Everolimus Eluting stent

bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) +Optimal Medical Treatment

bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment

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

Repeat revascularization (target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven)

cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

defined as death from cardiovascular causes, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina

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.

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.

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