Coronary Artery Disease
Conditions
Keywords
vulnerable plaque, coronary computed tomography angiography, preventive percutaneous coronary intervention
Brief summary
The PREVENT-2 trial is to determine whether an initial invasive strategy-consisting of early coronary angiography (CAG) with intent for preventive percutaneous coronary intervention (PCI) in addition to optimal medical therapy (OMT)-reduces the incidence of the primary composite outcome of cardiac death, target-vessel myocardial infarction (MI), unplanned urgent revascularization, or hospitalization for unstable or progressive angina at 3 years, compared with an initial conservative strategy of optimal medical therapy (OMT) alone, in patients with high-risk vulnerable plaque identified by coronary computed tomography angiography (CCTA).
Interventions
PROCEDUREInitial Invasive Strategy
Invasive coronary angiography (CAG) within 30 days after randomization, with the intent to perform preventive percutaneous coronary intervention (PCI) in addition to optimal medical therapy (OMT). For further detailed assessment of vulnerable plaque lesions detected by coronary computed tomography angiography, the use of intracoronary imaging modalities (near-infrared spectroscopy, optical coherence tomography, or intravascular ultrasound) will be strongly recommended.
DRUGInitial Conservative Strategy
Optimal medical therapy (OMT) alone, with invasive coronary angiography (CAG) reserved only for failure of optimal medical therapy, defined as recurrent or worsening symptoms despite maximally tolerated medical therapy, or the occurrence of an acute coronary event.
Sponsors
Seung-Jung Park
CardioVascular Research Foundation, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥18 years 2. Patients with suspected coronary artery disease (CAD) (e.g., chest pain syndrome or equivalent symptoms) who are evaluated with coronary computed tomography angiography (CCTA) 3. Coronary computed tomography angiography (CCTA) showing: Plaque with at least moderate stenosis in one or more major epicardial coronary arteries; and At least two high-risk plaque (HRP) feature at the site of stenotic lesions, defined as any of the following: * Low-attenuation plaque (LAP) (\<70 Hounsfield units) * Positive remodeling (PR) (remodeling index \>1.2) * Napkin-ring sign (NRS) * Spotty calcification (SC) (\<3 mm in length) 4. Willing and able to provide written informed consent
Exclusion criteria
1. Acute coronary syndrome (ACS) requiring urgent or emergent invasive evaluation 2. Hemodynamically unstable conditions 3. Significant left main coronary artery disease (≥50% diameter stenosis) 4. Coronary anatomy unsuitable for either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) 5. Left ventricular ejection fraction (LVEF) \<35% → Left ventricular ejection fraction \<35% 6. New York Heart Association (NYHA) class III or IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months 7. Prior coronary artery bypass grafting (CABG) 8. Severe renal dysfunction (estimated glomerular filtration rate \<30 mL/min/1.73 m²) or end-stage renal disease on dialysis 9. Contraindication to undergoing coronary computed tomography angiography (CTA) (e.g., allergy to radiographic contrast that cannot be adequately premedicated, any prior anaphylaxis to radiographic contrast, or inability to cooperate with scan acquisition) 10. Contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year 11. Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity 12. Planned cardiac or major noncardiac surgery within the study period 13. Women who are breastfeeding, pregnant, or planning to become pregnant during the course of the study 14. Inability to comply with the study protocol 15. Active participation in another interventional clinical trial involving an unapproved investigational drug or device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The event rate of Composite of death from cardiac causes, target-vessel myocardial infarction, unplanned urgent revascularization, or hospitalization for unstable or progressive angina at 3 years after randomization. | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The event rate of Individual components of the primary composite outcome | 3 years | death from cardiac causes, target-vessel myocardial infarction, unplanned urgent revascularization, or hospitalization for unstable or progressive angina at 3 years after randomization. |
| The event rate of Death (all-cause, cardiac, or non-cardiac causes) | 3 years | — |
| The event rate of Myocardial Infarction (any, periprocedural or spontaneous; target-vessel or non-target-vessel) | 3 years | — |
| The event rate of Revascularization (any, target-vessel, non-target-vessel) | 3 years | — |
| The event rate of Unplanned hospitalization for unstable or progressive angina | 3 years | — |
| The event rate of Hospitalization (any, cardiac or noncardiac causes) | 3 years | — |
| The event rate of Stent thrombosis (definite or probable) | 3 years | — |
| The event rate of stroke (any, ischemic, or hemorrhagic) | 3 years | — |
| The event rate of Bleeding events (Bleeding Academic Research Consortium (BARC) criteria) | 3 years | — |
| The event rate of Procedural complications requiring active intervention related to Percutaneous coronary intervention | 3 years | — |
| Patient-oriented composite outcome (POCO) (a composite of all-cause death, all myocardial infarction, or any repeat revascularization) | 3 years | — |
| Change in Angina-related quality of life (assessed by the Seattle Angina Questionnaire [SAQ]) | Baseline, 6 months, 1 year, 2 years, and 3 years | — |
| Economic evaluation of healthcare resource use, costs, and cost-effectiveness | From baseline to 3 years; assessed at 1 month, 6 months, 1 year, 2 years, and 3 years | Healthcare resource utilization (including hospitalizations, procedures, and outpatient visits) will be collected and used to estimate total healthcare costs. Cost-effectiveness will be assessed using the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY) gained. These components will be analyzed within a unified economic evaluation framework. |
Countries
South Korea
Contacts
CONTACTDuk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD
PRINCIPAL_INVESTIGATORDuk-woo Park, MD, PhD
Asan Medical Center
PRINCIPAL_INVESTIGATORJung-min Ahn, MD, PhD
Asan Medical Center
PRINCIPAL_INVESTIGATORDo-yoon Kang, MD, PhD
Asan Medical Center
Outcome results
None listed