In patients with non–flow-limiting vulnerable plaques, percutaneous coronary intervention (PCI) plus optimal medical therapy reduced the risk for adverse cardiac events and death compared with optimal medical therapy alone.
“PREVENT is the first randomized trial of vulnerable plaque treatment that was powered for clinical events,” coprincipal investigator Gregg W. Stone, MD, director of Academic Affairs for the Mount Sinai Heart Health System and a professor of cardiology and population health sciences and policy at the Icahn School of Medicine at Mount Sinai in New York City, told theheart.org | Medscape Cardiology in a preconference interview.
The previously reported PROSPECT ABSORB study, led by Stone, showed that such lesions could be safely treated with PCI, and “there were strong trends for reduced clinical events over time,” he said. “But that trial was powered for safety, not clinical events.”
The PREVENT trial findings “suggest that we may totally change the treatment paradigm for the types of lesions that should undergo revascularization,” he said. Such lesions — most commonly, thin cap fibroatheromas — are often relatively mild and would not provoke ischemia or angina, so guidelines don’t recommend treating them with PCI. “However, they’re the kind of plaques that place patients at risk for an acute coronary syndrome or myocardial infarction (MI) or sudden cardiac death.”
The PREVENT findings were presented on April 8 at the American College of Cardiology (ACC) Scientific Session 2024. The study was simultaneously published online in The Lancet.
Consistently Better Outcomes With PCI
The PREVENT trial was an open-label randomized controlled trial conducted at 15 research hospitals in South Korea, Japan, Taiwan, and New Zealand.
Patients with non–flow-limiting (fractional flow reserve > 0-80) vulnerable coronary plaques were randomly assigned to either PCI plus optimal medical therapy or optimal medical therapy alone, stratified by diabetes status and the performance of PCI in a nonstudy target vessel.
After PCI, all patients received dual antiplatelet therapy for at least 6 or 12 months. Optimal medical therapy for both the groups included lifestyle modifications and intensive, guideline-directed medical therapy for secondary prevention. High-dose statin therapy was strongly recommended but was left at the discretion of local investigators.
Follow-up was done at 1, 6, 12, and 24 months after randomization and every year thereafter, until the last enrolled patient reached 2 years after randomization.
The primary outcome was target vessel failure: A composite of death from cardiac causes, target vessel MI, ischemia-driven target vessel revascularization, or hospitalization for unstable or progressive angina at 2 years.
Secondary outcomes were the individual components of the primary composite outcome, death from any cause, any MI, any revascularization, definite stent or scaffold thrombosis, stroke, bleeding events, angina status, procedural complications, and the patientoriented composite of all-cause death, all MIs, or any repeat revascularization.
A total of1606 patients (median age, 65 years; 73% men) were randomly assigned (1:1) to PCI or optimal medical therapy alone.
Overall, 97% of patients (1556) completed the 2-year follow-up. The primary outcome occurred in three patients (0.4%) in the PCI group and in 27 patients (3%-4%) in the medical therapy group.
In the post hoc analysis, the composite rate of death from any cause or target vessel MI was consistently lower at 2 years with preventive PCI than with optimal medical therapy alone, as was the composite rate of death from cardiac causes or target vessel MI.
“Basically, we prevented every type of the component events — all of them were consistently reduced in the right direction,” Stone said, “and there were no major safety concerns with this therapy.”
Indeed, serious clinical or adverse events did not differ between the PCI and medical therapy groups: At 2 years, four (0.5%) vs 10 (1.3%) patients died and nine (1.1%) vs 13 (1.7%) had an MI.
In addition, the authors noted that in the post hoc as-treated analysis, the durability of preventive PCI seemed to be more sustained with cobalt-chromium everolimus-eluting metallic stents than with bioresorbable vascular scaffolds.
What’s Ahead
“Given that PREVENT is the first large trial to show the potential effect of the focal treatment for vulnerable plaques, these findings support consideration to expand indications for percutaneous coronary intervention to include non–flow-limiting, high-risk vulnerable plaques,” the authors wrote in The Lancet.
Seung-Jung Park, MD, professor in the Division of Cardiology at Asan Medical Center at the University of Ulsan College of Medicine in Seoul, Republic of Korea, who presented the findings said, “Further research is necessary to provide better identification of which patients or lesions can most benefit from invasive or noninvasive imaging evaluation for detection of vulnerable plaques, optimal risk-stratification, and the application of preventive PCI.”
Stone noted that although the data from this study are “pretty strong,” he would like to see a confirmatory study before recommending that clinicians start performing preventive PI for vulnerable lesions. “But I think it is a therapy that could be considered in select situations, after an informed discussion with the patient.”
In a linked comment, Josip A. Borovac, MD, of the University of Split School of Medicine, Split, Croatia, concluded that “the primary value of the PREVENT trial lies in its identification of a crucial subset of patients, primarily in the context of stable angina, who would have substantial mortality and morbidity benefits with preventive percutaneous coronary intervention compared with optimal medical therapy alone.”
“This discovery will have important clinical implications for the future management of these patients in contemporary clinical practice.”
The study was funded by the Cardiovascular Research Foundation, Abbott, Yuhan Corp, CAH-Cordis, Philips, and Infraredx (a Nipro company). Park reported research grants and speaker fees from Abbott Vascular, Medtronic, Daiichi-Sankyo, Chong Kun Dang Pharm, Daewoong Pharma, and Edwards. Stone reported fees from multiple pharmaceutical and biotech companies. Borovac declared no competing interests.
Marilynn Larkin, MA, is an award-winning medical writer and editor whose work has appeared in numerous publications, including Medscape Medical News and its sister publication MDedge, The Lancet (where she was a contributing editor), and Reuters Health.
