Preventive PCI + OMT for vulnerable plaques reduces risk of cardiac events: The PREVENT trial

07 Jun 2024

Patients with intracoronary imaging-defined vulnerable plaques (VP) have a higher risk of experiencing major adverse cardiac events.1 While optimal medical therapy (OMT) is the standard approach to stabilize plaque vulnerability, the effectiveness and safety of focal preventive percutaneous coronary intervention (PCI) have not been established.1  At the ACC Annual Scientific Session 2024, Professor Seung-Jung Park from the University of Ulsan College of Medicine, Seoul, South Korea, presented results from the PREVENT trial, which aimed to assess whether focal preventive PCI of non-flow-limiting imaging-defined VPs improves clinical outcomes compared to OMT alone.1

This trial recruited adult patients who had angiographically significant stenosis (>50%) with negative fractional flow reserve (FFR) (0.80) who met at least 2 of the following criteria for VP: 1) minimal lumen area (MLA)<4mm2, 2) plaque burden >70%, 3) thin-cap fibroatheroma (TCFA) detected by radiofrequency-based intravascular ultrasound (RF-IVUS) or optical coherence tomography (OCT), or 4) large lipid-rich plaque detected by near-infrared spectroscopy (NIRS) (maxLCBI4mm>315).1  Other key inclusion criteria were eligibility for PCI with a bioresorbable vascular scaffold (BVS) or everolimus-eluting stent (EES), reference vessel diameter of 2.75mm-4.0mm and lesion length of ≤40mm.1


In total, 1,608 patients who met the imaging criteria of VP were included and randomly assigned 1:1 to receive preventive PCI + OMT (n=803) or OMT alone (n=803).1 PCI was initially performed using BVS, but when these were withdrawn, cobalt-chromium everolimus-eluting metallic stents (CoCr-EES) were used as the default device of PCI.1 Patients received dual antiplatelet therapy (DAPT) for at least 6 or 12 months after PCI according to clinical presentation and anatomical complexity.1 Patients were followed up at 1, 6, 12  and 24 months and every year thereafter until the last enrolled patient reached 2 years after randomization.1

The primary endpoint of the study was target vessel failure, which was a composite of death from cardiac causes, target vessel myocardial infarction, ischemia-driven target vessel revascularization, or hospitalization for unstable or progressive angina, at 2 years post-randomization.1 Results of the trial showed that the cumulative incidence of target vessel failure at 2 years follow-up was significantly lower in the preventive PCI + OMT group compared to the OMT alone group (0.4% vs. 3.4%; HR=0.11; 95% CI: 0.03-0.36; log-rank p=0.0003).1 At 7 years follow-up, the trend remained the same with a cumulative incidence of 6.5% in the PCI + OMT group compared to 9.4% in the OMT alone group (HR=0.54. 95% CI: 0.33-0.87; log-rank p=0.0097).1

The secondary endpoints of the study were individual components of the primary composite outcome, a patient-oriented composite outcome (all-cause mortality, all myocardial infarctions, or any repeat revascularization), procedural safety outcomes, stroke, bleeding events and number of anti-anginal medications used at each time point.1 Within the primary composite outcome, only ischemia-driven target vessel revascularization (HR=0.44; 95% CI: 0.25-0.77) and hospitalization for unstable or progressive angina (HR=0.19; 95% CI: 0.06-0.54) were significantly improved with PCI + OMT compared to OMT alone.1 The cumulative incidence of the patient-oriented composite outcome was also significantly lower in the preventive PCI + OMT group compared to the OMT alone group at 7 years follow-up (14.4% vs. 19.3%; HR=0.69; 95% CI: 0.50-0.95; log-rank p=0.022).1 Individual components within the patient-oriented composite outcome, as well as stroke and major bleeding events, were not significantly different between the groups.1

Subgroup analyses of the primary outcome did not show any significant differences at 2-year follow-up, but patients who had PCI of non-target vessel, median diameter stenosis of ≥55% by quantitative coronary angiography, or who received PCI with CoCr-EES instead of BVS, experienced greater clinical benefit at 7-year follow-up with PCI + OMT compared to OMT alone.1

In summary, the PREVENT trial is the first large-scale, randomized controlled study to compare preventive PCI + OMT with OMT alone for the treatment of non-flow limiting, imaging-defined VPs.1 Preventive PCI + OMT resulted in a lower incidence of major adverse cardiac events and this benefit was sustained throughout the 7-year follow-up period, thus providing new insights on the role of preventive PCI for VPs in the future.

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