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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02316886
Recruitment Status : Active, not recruiting
First Posted : December 15, 2014
Last Update Posted : February 22, 2023
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Plaque, Atherosclerotic Device: Coronary intervention Drug: Optimal Medical treatment Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1608 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 5, 2015
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Coronary intervention
bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) +Optimal Medical Treatment
 Device: Coronary intervention
bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment
Active Comparator: Optimal Medical Treatment
Optimal Medical Treatment
 Drug: Optimal Medical treatment


Outcome Measures
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Primary Outcome Measures :
  1. Target vessel failure [ Time Frame: 2 years ]
    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


Secondary Outcome Measures :
  1. Death from cardiac causes [ Time Frame: 2 years ]
  2. Target-vessel myocardial infarction [ Time Frame: 2 years ]
  3. Ischemic-driven target-vessel revascularization [ Time Frame: 2 years ]
  4. Hospitalization for unstable or progressive angina [ Time Frame: 2 years ]
  5. Death from all, cardiac, or noncardiac causes [ Time Frame: 2 years ]
  6. Myocardial infarction [ Time Frame: 2 years ]
    Periprocedural or spontaneous, target-vessel or non-target-vessel related

  7. Repeat revascularization [ Time Frame: 2 years ]
    Repeat revascularization (target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven)

  8. Any hospitalization for cardiac or noncardiac causes [ Time Frame: 2 years ]
  9. Target-lesion failure [ Time Frame: 2 years ]
    cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

  10. Major adverse cardiac event [ Time Frame: 2 years ]
    defined as death from cardiovascular causes, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina

  11. Composite of any death, myocardial infarction, or repeat revascularization [ Time Frame: 2 years ]
    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.

  12. Rate of Scaffold or stent thrombosis [ Time Frame: 2 years ]
  13. Rate of Stroke [ Time Frame: 2 years ]
  14. Rate of Bleeding events [ Time Frame: 2 years ]
    life-threatening or disabling, major or minor

  15. Rate of Nonurgent revascularization procedures [ Time Frame: 2 years ]
  16. Functional class [ Time Frame: 2 years ]

    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.


  17. Number of anti-anginal medications administered [ Time Frame: 2 years ]
    Number of anti-anginal medication at each point in time


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316886


Locations
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Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
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Principal Investigator: Duk-woo Park, MD Asan Medical Center
More Information
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Responsible Party: Seung-Jung Park, MD,PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02316886    
Other Study ID Numbers: AMCCV2014-13
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: February 22, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Seung-Jung Park, Asan Medical Center:
coronary intervention
Vulnerable Plaque
Insignificant Stenosis
Bioresorbable Vascular Scaffold
Everolimus Eluting stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Plaque, Atherosclerotic
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical