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

Seung-Jung Park

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Plaque, Atherosclerotic

Treatments

Device: Coronary intervention

Drug: Optimal Medical treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02316886

AMCCV2014-13

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,608 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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