Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

NCT02316886 | Completed Phase 4 DMC

• 1 other identifier: AMCCV2014-13
• Study Type: interventional
• Target: 1,608
• Locations: 5 countries
• Sites: 18

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.

Conditions

Coronary Artery Disease; Plaque, Atherosclerotic

Keywords

coronary intervention; Vulnerable Plaque; Insignificant Stenosis; Bioresorbable Vascular Scaffold; Everolimus Eluting stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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

Study Arms (2)

Coronary intervention

EXPERIMENTAL

bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) +Optimal Medical Treatment

Device: Coronary intervention

Optimal Medical Treatment

ACTIVE COMPARATOR

Optimal Medical Treatment

Drug: Optimal Medical treatment

Interventions

Coronary intervention DEVICE

bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment

Coronary intervention

Optimal Medical treatment DRUG

Optimal Medical Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• MLA(minimal luminal area)\<4mm2
• Plaque burden\>70%
• Large lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy), defined as MaxLCBI4mm\>315
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (18)

Columbia University Medical Center

New York, New York, United States

Location

Kyoto University Hospital

Kyoto, Japan

Location

Christchurch Hospital and Canterbury DHB, University of Otago

Christchurch, New Zealand

Location

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Gangwon National Univ. Hospital

Chuncheon, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

ChonBuk National University Hospital

Jeonju, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University hospital

Seoul, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Location

Bundang Cha Medical Center

Sŏngnam, South Korea

Location

Seoul National University Bundang hospital

Sŏngnam, South Korea

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (2)

• Park SJ, Ahn JM, Kang DY, Yun SC, Ahn YK, Kim WJ, Nam CW, Jeong JO, Chae IH, Shiomi H, Kao HL, Hahn JY, Her SH, Lee BK, Ahn TH, Chang KY, Chae JK, Smyth D, Mintz GS, Stone GW, Park DW; PREVENT Investigators. Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial. Lancet. 2024 May 4;403(10438):1753-1765. doi: 10.1016/S0140-6736(24)00413-6. Epub 2024 Apr 8.

  PMID: 38604213 DERIVED

• Ahn JM, Kang DY, Lee PH, Ahn YK, Kim WJ, Nam CW, Jeong JO, Chae IH, Shiomi H, Kao PHL, Hahn JY, Her SH, Lee BK, Ahn TH, Chang K, Chae JK, Smyth D, Stone GW, Park DW, Park SJ; PREVENT Investigators. Preventive PCI or medical therapy alone for vulnerable atherosclerotic coronary plaque: Rationale and design of the randomized, controlled PREVENT trial. Am Heart J. 2023 Oct;264:83-96. doi: 10.1016/j.ahj.2023.05.017. Epub 2023 Jun 2.

  PMID: 37271356 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Plaque, Atherosclerotic

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Duk-woo Park, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 15, 2014
• Study Start: October 5, 2015
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

NZ (1); JP (1); US (1); KR (14); TW (1)