PREVENT Investigates Benefits of Preventive PCI for High-Risk Coronary Plaque

April 8, 2024—Two-year data from the PREVENT trial showed that patients who underwent preventive percutaneous coronary intervention (PCI) were 89% less likely to experience the study’s composite primary endpoint of cardiac death, target vessel myocardial infarction (MI), target vessel revascularization, or hospitalization for unstable or progressive chest pain compared with those patients who received medications alone.

According to the American College of Cardiology (ACC), these new findings suggest that patients with high-risk plaque that is likely to rupture could benefit from PCI as a preemptive measure rather than waiting for a MI or other severe reduction in blood flow to occur.

Seung-Jung Park, MD, presented the study at the ACC.24 Annual Scientific Session held April 6-8 in Atlanta, Georgia. The findings were simultaneously published by Dr. Park, et al online in The Lancet.

In its press release, the ACC stated that PREVENT is the largest study on preventive PCI to date. Additionally, ACC noted that PREVENT is the first study with a large enough sample size to assess clinical outcomes of its use in treating vulnerable plaque. Preventive PCI involves patients whose blockages were not severe enough to cause symptoms or ischemia and would not otherwise undergo PCI according to current standard of care.

Dr. Park, who is Professor in the Division of Cardiology at Asan Medical Center at the University of Ulsan College of Medicine in Seoul, South Korea, commented in the ACC press release, “PREVENT has now shown that preventive PCI may reduce the 2-year and long-term risks of major cardiac events arising from vessels containing vulnerable plaques. These findings demonstrate that the focal treatment of high-risk vulnerable plaques may improve patient prognosis beyond optimal medical therapy alone.”

The study aimed to test this strategy of preventive PCI—whereby a stent could help to stabilize a high-risk plaque lesion and thus reduce its risk of rupture before a MI occurs.

The investigators enrolled 1,606 patients treated for coronary artery disease at 15 centers in four countries. All patients had plaque that was considered vulnerable to rupture (as assessed with intravascular imaging) but was not limiting blood flow through the artery (as indicated by a fractional flow reserve > 0.8). The average age of patients in the study was 64 years.

Half of the patients were randomly assigned to receive PCI plus medical therapy and half received medical therapy alone.

Optimal medical therapy for coronary artery disease includes lifestyle modifications and intensive pharmacologic interventions, according to the contemporary guideline-directed medical therapy for secondary prevention. High-dose statin therapy was strongly recommended in both groups.

The ACC press release summarized the results as follows:

• At 2 years, the composite primary endpoint occurred in three patients who received PCI (0.4% of the PCI group) and in 27 patients who received medications alone (3.4% of the controls), representing an 89% lower risk of the composite primary endpoint among those who received PCI.
• The cumulative incidence of this composite endpoint remained significantly lower in the PCI group through long-term follow-up over a median of 4.4 years (maximum up to 7.9 years), with patients receiving PCI showing a 46% lower risk of the composite endpoint across this period.
• Rates for each component of the composite primary endpoint were also lower in the PCI group, as were the composite rate of death from any cause or heart attack in the target vessel or any revascularization.

Because patients in the study and their clinicians were aware of which treatment patients were assigned to receive, the lack of blinding could have introduced bias and influenced the study results, advised the investigators.

Dr. Park further noted that the study was limited to patients with non–flow-limiting plaque that was detected with intravascular imaging and is not necessarily generalizable beyond this patient population. The study also was geographically limited to East Asia and approximately three-quarters of the patients were men.

“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 plaque, optimal risk-stratification, and the application of preventive PCI,” commented Dr. Park in the ACC press release.

Finally, the press release stated that the investigators said that the observed rates of the primary outcome were lower than expected in both groups and that this could be related to a combination of factors, including the relatively low proportion of study participants with acute coronary syndromes; improvements in medical therapy and in PCI equipment and techniques, including the use of intravascular imaging-guided PCI; and effective control of risk factors such as low-density lipoprotein cholesterol.