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.
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.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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