Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

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.

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:

  1. MLA(minimal luminal area)<4mm2
  2. Plaque burden>70%
  3. Large lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy), defined as MaxLCBI4mm>315
  4. 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