Clinical trial NCT02316886: Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque
Official title: a Multinational, Multicenter, Prospective, Open-label, Active-treatment-controlled Randomized Trial: Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque_PREVENT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Plaque, Atherosclerotic
Keywords: coronary intervention
Vulnerable Plaque
Insignificant Stenosis
Bioresorbable Vascular Scaffold
Everolimus Eluting stent
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2014-12-15
Enrollment: 1608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

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

Primary outcomes:
measure: Target vessel failure
timeFrame: 2 years
Secondary outcomes:
measure: Death from cardiac causes
timeFrame: 2 years
measure: Target-vessel myocardial infarction
timeFrame: 2 years
measure: Ischemic-driven target-vessel revascularization
timeFrame: 2 years
measure: Hospitalization for unstable or progressive angina
timeFrame: 2 years
measure: Death from all, cardiac, or noncardiac causes
timeFrame: 2 years
measure: Myocardial infarction
timeFrame: 2 years
measure: Repeat revascularization
timeFrame: 2 years
measure: Any hospitalization for cardiac or noncardiac causes
timeFrame: 2 years
measure: Target-lesion failure
timeFrame: 2 years
measure: Major adverse cardiac event
timeFrame: 2 years
measure: Composite of any death, myocardial infarction, or repeat revascularization
timeFrame: 2 years
measure: Rate of Scaffold or stent thrombosis
timeFrame: 2 years
measure: Rate of Stroke
timeFrame: 2 years
measure: Rate of Bleeding events
timeFrame: 2 years
measure: Rate of Nonurgent revascularization procedures
timeFrame: 2 years
measure: Functional class
timeFrame: 2 years
measure: Number of anti-anginal medications administered
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Jeonju
country: Korea, Republic of
facility: ChonBuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Sŏngnam
country: Korea, Republic of
facility: Bundang Cha Medical Center
city: Sŏngnam
country: Korea, Republic of
facility: Seoul National University Bundang hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital and Canterbury DHB, University of Otago
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Asan Medical Center
name: Duk-woo Park, MD
role: PRINCIPAL_INVESTIGATOR
References: