Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

NCT ID: NCT02316886

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1608 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-05
• Study Completion Date: 2023-10-19

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.

Conditions

Coronary Artery Disease; Plaque, Atherosclerotic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Coronary intervention

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

Group Type: EXPERIMENTAL

Coronary intervention

Intervention Type: DEVICE

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

Optimal Medical Treatment

Optimal Medical Treatment

Group Type: ACTIVE_COMPARATOR

Optimal Medical treatment

Intervention Type: DRUG

Interventions

Coronary intervention

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

Intervention Type: DEVICE

Optimal Medical treatment

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

MD,PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Duk-woo Park, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Columbia University Medical Center

New York, New York, United States

Kyoto University Hospital

Kyoto, , Japan

Christchurch Hospital and Canterbury DHB, University of Otago

Christchurch, , New Zealand

Asan Medical Center

Seoul, Songpa-gu, South Korea

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Gangwon National Univ. Hospital

Chuncheon, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

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

Daejeon, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Gachon University Gil Hospital

Incheon, , South Korea

ChonBuk National University Hospital

Jeonju, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University hospital

Seoul, , South Korea

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

Seoul, , South Korea

Bundang Cha Medical Center

Sŏngnam, , South Korea

Seoul National University Bundang hospital

Sŏngnam, , South Korea

National Taiwan University Hospital

Taipei, , Taiwan

Countries

United States; Japan; New Zealand; South Korea; Taiwan

References

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.

Reference Type: DERIVED

PMID: 38604213 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37271356 (View on PubMed)

Other Identifiers

AMCCV2014-13

Identifier Type: -

Identifier Source: org_study_id