PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2

Official title

A Comparison of Initial Invasive Strategy and Initial Conservative Strategy for the Treatment of Vulnerable Atherosclerotic Coronary Plaques Identified by Coronary CT Angiography

Overview

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

• Procedure Initial 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.
• Drug Initial 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.

Primary outcome measures

• 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. [Time frame: 3 years]

Secondary outcome measures (12)

• The event rate of Individual components of the primary composite outcome [Time frame: 3 years]
• The event rate of Death (all-cause, cardiac, or non-cardiac causes) [Time frame: 3 years]
• The event rate of Myocardial Infarction (any, periprocedural or spontaneous; target-vessel or non-target-vessel) [Time frame: 3 years]
• The event rate of Revascularization (any, target-vessel, non-target-vessel) [Time frame: 3 years]
• The event rate of Unplanned hospitalization for unstable or progressive angina [Time frame: 3 years]
• The event rate of Hospitalization (any, cardiac or noncardiac causes) [Time frame: 3 years]
• The event rate of Stent thrombosis (definite or probable) [Time frame: 3 years]
• The event rate of stroke (any, ischemic, or hemorrhagic) [Time frame: 3 years]
• The event rate of Bleeding events (Bleeding Academic Research Consortium (BARC) criteria) [Time frame: 3 years]
• The event rate of Procedural complications requiring active intervention related to Percutaneous coronary intervention [Time frame: 3 years]
• Patient-oriented composite outcome (POCO) (a composite of all-cause death, all myocardial infarction, or any repeat revascularization) [Time frame: 3 years]
• Change in Angina-related quality of life (assessed by the Seattle Angina Questionnaire [SAQ]) [Time frame: Baseline, 6 months, 1 year, 2 years, and 3 years]

Eligibility criteria

Inclusion criteria

• Patients aged ≥18 years
• Patients with suspected coronary artery disease (CAD) (e.g., chest pain syndrome or equivalent symptoms) who are evaluated with coronary computed tomography angiography (CCTA)
• 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)
• Willing and able to provide written informed consent

Exclusion criteria

• Acute coronary syndrome (ACS) requiring urgent or emergent invasive evaluation
• Hemodynamically unstable conditions
• Significant left main coronary artery disease (≥50% diameter stenosis)
• Coronary anatomy unsuitable for either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
• Left ventricular ejection fraction (LVEF) <35%

→ Left ventricular ejection fraction <35%

• 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
• Prior coronary artery bypass grafting (CABG)
• Severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²) or end-stage renal disease on dialysis
• 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)
• Contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year
• Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
• Planned cardiac or major noncardiac surgery within the study period
• Women who are breastfeeding, pregnant, or planning to become pregnant during the course of the study
• Inability to comply with the study protocol
• Active participation in another interventional clinical trial involving an unapproved investigational drug or device

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

South Korea · 1 center

• Asan Medical Center — Seoul

Identifiers

NCT: NCT07569692 · AMCCV 2026-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗