ACC.24 - In patients with non–flow-limiting vulnerable coronary plaques, preventive PCI reduced the risk of major adverse cardiac events throughout the 7-year follow-up, compared with optimal medical therapy only.

This summary is based on the presentation of Seung-Jung Park, MD (Seoul, South Korea) at the ACC.24 Scientific Session - Preventive PCI or Medical Therapy Alone For Atherosclerotic Coronary Vulnerable Plaques.

Introduction and methods

ACS and sudden cardiac death are often caused by rupture and thrombosis of lipid-rich atherosclerotic coronary plaques. Many of these vulnerable plaques are non–flow-limiting but can be identified with intravascular imaging. Currently, optimal medical therapy (OMT) is the standard treatment to stabilize plaques. The safety and effectiveness of focal preventive PCI for non–flow-limiting vulnerable plaques are unknown.

The PREVENT (Preventive Coronary Intervention on Stenosis With Functionally Insignificant Vulnerable Plaque) trial was a multinational, multicenter, open-label, phase 4 RCT in which 1606 patients with 1 or 2 non–flow-limiting (i.e., fractional flow reserve >0.80) vulnerable plaques identified by intracoronary imaging were randomized to preventive PCI plus OMT or OMT only. Median follow-up duration was 4.4 years (maximum: 7.9).

The primary endpoint was a composite outcome of death from cardiac causes, target-vessel MI, ischemia-driven target-vessel revascularization, or hospitalization for unstable or progressive angina, all assessed at 2 years. Secondary endpoints included the individual components of the primary endpoint and a patient-oriented composite outcome of all-cause mortality, all MIs, or any revascularization.

Main results

• At 2 years, the primary outcome had occurred in 3 patients (0.4%) assigned to preventive PCI plus OMT (n=803) and 27 patients (3.4%) who received OMT only (n=803) (HR: 0.11; 95%CI: 0.03–0.36; log-rank P=0.0003).
• The treatment effect of preventive PCI over OMT only was driven by a reduction in each individual component of the primary composite endpoint, although the differences in the rates of target-vessel MI and death from cardiac causes were statistically nonsignificant.
• Over the entire follow-up period of 7 years, the cumulative incidence of the primary endpoint was also lower in the PCI group than the OMT only group (6.5% vs. 9.4%; HR: 0.54; 95%CI: 0.33–0.87; log-rank P=0.0097).
• The cumulative incidence rate of the patient-oriented composite outcome at 7 years was 14.4% in the PCI group and 19.3% in the OMT only group (HR: 0.69; 95%CI: 0.50–0.95; log-rank P=0.022).
• The frequency of serious clinical or adverse events did not differ between the PCI and OMT only groups. Less than 1% of 741 patients experienced ≥1 preventive PCI–related adverse events.

Conclusion

In patients with non–flow-limiting vulnerable coronary plaques, preventive PCI plus OMT reduced the risk of major adverse cardiac events at 2 years and continued throughout the 7-year follow-up, compared with OMT only.

 - Our reporting is based on the information provided at the ACC.24 Scientific Session -

The findings of this study were simultaneously published in Lancet.