Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

Coronary Artery Disease Clinical Trial

— PREVENT  

Official title:

a Multinational, Multicenter, Prospective, Open-label, Active-treatment-controlled Randomized Trial: Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque_PREVENT Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316886
• Other study ID #: AMCCV2014-13
• Status: Completed
• Phase: Phase 4
• Start date: October 5, 2015
• Est. completion date: October 19, 2023

Study information

• Verified date: November 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1608
• Est. completion date: October 19, 2023
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Plaque, Atherosclerotic

Intervention

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

Drug:
• Optimal Medical treatment

Locations

Country	Name	City	State
Japan	Kyoto University Hospital	Kyoto
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Gangwon National Univ. Hospital	Chuncheon
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	Chonnam National University Hospital	Gwangju
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	ChonBuk National University Hospital	Jeonju
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Bundang Cha Medical Center	Songnam
Korea, Republic of	Seoul National University Bundang hospital	Songnam
New Zealand	Christchurch Hospital and Canterbury DHB, University of Otago	Christchurch
Taiwan	National Taiwan University Hospital	Taipei
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Countries where clinical trial is conducted

United States,  Japan,  Korea, Republic of,  New Zealand,  Taiwan, 

Outcome

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