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).
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)
Low-attenuation plaque (LAP) (<70 Hounsfield units)
Positive remodeling (PR) (remodeling index >1.2)
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)
Parallel
Initial Invasive Strategy
Procedure/SurgeryInvasive 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
DrugOptimal 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.
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.
The event rate of Individual components of the primary composite outcome
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)
The event rate of Myocardial Infarction (any, periprocedural or spontaneous; target-vessel or non-target-vessel)
The event rate of Revascularization (any, target-vessel, non-target-vessel)
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Seung-Jung Park
Lead sponsor
Asan Medical Center
Sponsor institution
CardioVascular Research Foundation, Korea
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
