The following is a summary of “Preventive PCI or medical therapy alone for vulnerable atherosclerotic coronary plaque: Rationale and design of the randomised, controlled PREVENT trial,” published in the October 2023 issue of Heart Journal by Ahn, et al.
The rupture of a susceptible plaque is a common cause of acute coronary syndromes, which may often give the appearance of a less severe condition on an angiogram. The potential function of preventative local treatment for the susceptible plaque has yet to be identified, even though pharmacologic control is regarded as the standard therapy for stabilizing plaque vulnerability. In patients with functionally nonsignificant high-risk susceptible plaques, the PREVENT study was intended to compare preventive percutaneous coronary intervention (PCI) with optimum medical therapy (OMT) with OMT alone. This comparison was to be made between the two treatment groups.
The PREVENT study is a prospective, open-label, active-treatment-controlled randomized experiment that is being conducted across several centers and countries throughout the world. Patients must have at least one angiographically significant stenosis (diameter stenosis more than 50% based on visual assessment) that does not have any functional relevance (fractional flow reserve [FFR] greater than 0.80) to be eligible for this treatment. Target lesions are assessed by intracoronary imaging and must meet at least 2 imaging criteria for vulnerable plaque; minimal lumen area <4.0 mm2; plaque burden >70%; maximal lipid core burden index in a 4 mm segment >315 by near-infrared spectroscopy; and thin cap fibroatheroma as determined by virtual histology or optical coherence tomography. Patients who enrolled in the study were given one of two possible treatment options: preventative PCI with either bioabsorbable vascular scaffolds or metallic everolimus-eluting stents with OMT or OMT alone. Patients received their assignments randomly in a ratio of 1:1. At two years following randomization, the main outcome is a target-vessel failure, which is defined as the composite of death from cardiac causes, target-vessel myocardial infarction, ischemic-driven target-vessel revascularization, or hospitalization for unstable or progressive angina.
A grand number of 1,608 people have been successfully enrolled in the study. The principal findings are anticipated to be available at the beginning of 2024, as well as the month in which the follow-up on the final patient recruited in the study will be finished.
The PREVENT study is the first large-scale, randomized trial that is sufficiently powered for clinical outcomes to examine the efficacy of preventive PCI on non–non-flow-limiting susceptible plaques comprising several high-risk characteristics. The purpose of this experiment is to determine whether or not preventive PCI reduces the risk of future cardiovascular events. The results of PREVENT will give convincing data on the question of whether or not OMT combined with preventative PCI of susceptible plaques improves patient outcomes in comparison to OMT performed alone.