PCI performed preventively in patients with high-risk vulnerable plaques was found to be superior to optimal medical therapy alone in preventing a serious cardiac event, according to the results of the PREVENT trial, the largest study on preventive PCI to date, presented during a Late-Breaking Clinical Trial session during ACC.24 in Atlanta and published simultaneously in The Lancet.

The multicenter, open-label trial, conducted between September 2015 and September 2021 at 15 centers in Japan, South Korea, Taiwan and New Zealand, randomized 1,606 patients (median age 64, 73% men) with vulnerable plaques and a fractional flow reserve >0.80 to either PCI plus medical therapy or optimal medical therapy alone.

Results showed that at two years, people who underwent preventive PCI were 89% less likely than the control group to experience the composite primary endpoint of cardiac death, target-vessel myocardial infarction (MI), target-vessel revascularization due to ischemia or hospitalization for unstable or progressive chest pain. The composite endpoint occurred in three patients who received PCI (0.4%) and 27 who received medications alone (3.4%) (p=0.003).

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.

Additionally, 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 target-vessel MI or any revascularization. At two years, four patients (0.5%) in the PCI group had died compared to 10 (1.3%) in the control group. Nine (1.1%) patients had an MI in the PCI group vs. 13 (1.7%) in the control group. Serious clinical or adverse effects did not differ between the two groups.

"PREVENT has now shown that preventive PCI may reduce the two-year and long-term risks of major cardiac events arising from vessels containing vulnerable plaques," said the study's lead author, Seung-Jung Park, MD, PhD, FACC. "These findings demonstrate that the focal treatment of high-risk vulnerable plaques may improve patient prognosis beyond optimal medical therapy alone."

The researchers acknowledged the lack of blinding as study limitation, along with limiting patients to those with non-flow-limiting plaques detected with intravascular imaging and enrollment of mostly East Asian 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 plaques, optimal risk-stratification and the application of preventive PCI," Park said.