Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

Phase 4

Completed

• Conditions: Coronary Artery Disease; Plaque, Atherosclerotic
• Interventions: Drug: Optimal Medical treatment; Device: Coronary intervention

• Registration Number: NCT02316886
• Lead Sponsor: Seung-Jung Park

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.

Study Timeline

• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-15
• Study Start: 2015-10-05
• Primary Completion: 2023-10-19
• Study Completion: 2023-10-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1608

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimal Medical Treatment	Optimal Medical treatment	Optimal Medical Treatment
Coronary intervention	Coronary intervention	bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) +Optimal Medical Treatment

Primary Outcome Measures

Name	Time	Method
Target vessel failure	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

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

Trial Locations

Locations (18)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Gangwon National Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

ChonBuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

The Catholic University of Korea Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang hospital; 🇰🇷 Sŏngnam, Korea, Republic of

Kyoto University Hospital; 🇯🇵 Kyoto, Japan

Bundang Cha Medical Center; 🇰🇷 Sŏngnam, Korea, Republic of

Seoul National University hospital; 🇰🇷 Seoul, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

The Catholic University of Korea, Daejeon ST. Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

Gachon University Gil Hospital; 🇰🇷 Incheon, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Christchurch Hospital and Canterbury DHB, University of Otago; 🇳🇿 Christchurch, New Zealand

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan