Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

Seung-Jung Park1,608 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,608

Conditions

Coronary Artery Disease Plaque, Atherosclerotic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

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

...and 8 more locations

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

Death from cardiac causes

Time frame: 2 years

Target-vessel myocardial infarction

Time frame: 2 years

Ischemic-driven target-vessel revascularization

Time frame: 2 years

Hospitalization for unstable or progressive angina

Time frame: 2 years

Death from all, cardiac, or noncardiac causes

Time frame: 2 years

Myocardial infarction

Periprocedural or spontaneous, target-vessel or non-target-vessel related

Time frame: 2 years

Repeat revascularization

Repeat revascularization (target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven)

Time frame: 2 years

Any hospitalization for cardiac or noncardiac causes

Time frame: 2 years

Target-lesion failure

cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

Time frame: 2 years

Major adverse cardiac event

defined as death from cardiovascular causes, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina

Time frame: 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.

Time frame: 2 years

Rate of Scaffold or stent thrombosis

Time frame: 2 years

Rate of Stroke

Time frame: 2 years

Rate of Bleeding events

life-threatening or disabling, major or minor

Time frame: 2 years

Rate of Nonurgent revascularization procedures

Time frame: 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.

Time frame: 2 years

Number of anti-anginal medications administered

Number of anti-anginal medication at each point in time

Time frame: 2 years

Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

Overview

Conditions

Interventions

Eligibility

Locations (18)

Outcomes

Primary Outcomes

Secondary Outcomes