Acute coronary syndrome and sudden cardiac death are most often caused by rupture and thrombosis of non-flow-limiting, lipid-rich atherosclerotic coronary plaques (vulnerable plaques). The safety and effectiveness of optimal medical therapy (OMT) with percutaneous coronary intervention for vulnerable plaques in reducing adverse cardiac events are unknown. The PREVENT study aims to compare the safety and effectiveness of OMT with non-flow limiting (FFR>0.80) preventive percutaneous coronary intervention (PCI) for vulnerable plaques on intravascular imaging, compared to OMT alone.

Non-culprit lesions with visual stenosis of >50% on coronary angiography due to stable ischemic heart disease or acute coronary syndrome, lesions with FFR >0.80 (non-flow limiting) and lesions that meet two of the following criteria* (definition of vulnerable plaque defined by imaging) were included in the study. *Minimal lumen area (MLA) ?4.0 mm2, plaque burden >70%, thin-capped fibroatheroma by OCT or IVUS, lipid-rich plaque (near-infrared spectroscopy, maxLCBI4mm >315). Patients were randomized 1:1 open-label to preventive PCI + OMT (n = 803) and OMT alone (n = 803). The primary outcome was the composite of death from cardiac causes, target vessel myocardial infarction, ischemia-induced target vessel revascularization, or hospitalization for unstable or progressive angina at 2 years after randomization.

In the study population, stable ischemic heart disease was 84%, unstable angina was 12%, and NSTEMI was 3%. Average follow-up period are 2 years and 7 years, average patient age 64.5 years, female gender 27%, diabetes mellitus 31%. Left ventricular ejection fraction 63%. LDL average is 91 mg/dl. Median FFR of target lesions 0.87. Primary outcome results at 2 years for PCI + OMT and OMT alone: 0.4% versus 3.4% (HR 0.11, 95% CI 0.03-0.36, p = 0.0003). All-cause mortality at 2 years: 0.5% vs. 1.3% (p > 0.05). All MI at 2 years: 1.1% etc. 1.7%, (p > 0.05). Primary outcome at 7 years for PCI + OMT and OMT alone: 6.5% vs 9.4% (HR 0.54, 95% CI 0.33-0.87, p = 0.0097).

In patients with non-flow-limiting vulnerable coronary plaques, preventive percutaneous coronary intervention reduced major adverse cardiac events from high-risk vulnerable plaques compared with optimal medical therapy alone.

The PREVENT trial showed that preventive PCI combined with OMT was superior to OMT alone in high-risk non-culprit coronary stenosis (FFR >0.80 measured and evidence of vulnerable plaque on intravascular imaging) with stable ischemic heart disease (the majority) with angiographic >50% stenosis (at 2 and 7-year follow-up).