Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

Launched by SEUNG-JUNG PARK · Dec 11, 2014

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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