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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,500
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.
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.
Asan Medical Center
Seoul, South Korea
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
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.
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
Economic evaluation of healthcare resource use, costs, and cost-effectiveness
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.
Time frame: From baseline to 3 years; assessed at 1 month, 6 months, 1 year, 2 years, and 3 years
Duk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD
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