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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Plaque, Atherosclerotic
• Intervention / Treatment: Drug: Optimal Medical treatment; Device: Coronary intervention

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 Type: Interventional
• Enrollment (Actual): 1608
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Kyoto, Japan
    • Kyoto University hospital
• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Chuncheon, Korea, Republic of
    • Gangwon National Univ. Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Seoul St. Mary's Hospital
  • Sŏngnam, Korea, Republic of
    • Bundang CHA Medical Center
  • Sŏngnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Asan Medical Center
• New Zealand
  • Christchurch, New Zealand
    • Christchurch Hospital and Canterbury DHB, University of Otago
• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
• United States
  • New York
    • New York, New York, United States
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Optimal Medical Treatment	Drug: Optimal Medical 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel failure	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death from cardiac causes		2 years
Target-vessel myocardial infarction		2 years
Ischemic-driven target-vessel revascularization		2 years
Hospitalization for unstable or progressive angina		2 years
Death from all, cardiac, or noncardiac causes		2 years
Myocardial infarction	Periprocedural or spontaneous, target-vessel or non-target-vessel related	2 years
Repeat revascularization	Repeat revascularization (target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven)	2 years
Any hospitalization for cardiac or noncardiac causes		2 years
Target-lesion failure	cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization	2 years
Major adverse cardiac event	defined as death from cardiovascular causes, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina	2 years
Composite of any death, myocardial infarction, or repeat revascularization	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.	2 years
Number of anti-anginal medications administered	Number of anti-anginal medication at each point in time	2 years
Rate of Scaffold or stent thrombosis		2 years
Rate of Stroke		2 years
Rate of Bleeding events	life-threatening or disabling, major or minor	2 years
Rate of Nonurgent revascularization procedures		2 years
Functional class	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.	2 years

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Duk-woo Park, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2015
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): October 19, 2023

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimated): December 15, 2014

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Bioresorbable Vascular Scaffold; coronary intervention; Vulnerable Plaque; Insignificant Stenosis; Everolimus Eluting stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Disease; Coronary Artery Disease; Plaque, Atherosclerotic
• Other Study ID Numbers: AMCCV2014-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED