Key Points:
- Vulnerable plaques can lead to acute coronary syndromes, but it is unknown whether performing PCI on these lesions improves outcomes.
- In this RCT, patients with at least one non-flow limiting vulnerable plaque who received PCI plus OMT had significantly lower rates of target-vessel failure compared to OMT alone at a median follow up of 4.4 years.
Intracoronary imaging is able to define vulnerable plaques (VP) which are associated with an increased risk of major adverse cardiac events. Currently, optimal medical therapy (OMT) is the standard to treat non-obstructive VP. Whether focal preventative percutaneous coronary intervention (PCI) of non-flow limiting VP can further reduce this risk is uncertain.
On April 8, 2024, the principal results of the “PREVENT: Preventive PCI versus Medical Therapy Alone for Treatment of Vulnerable Atherosclerotic Coronary Plaques” were presented at ACC Scientific Sessions 2024 as a Late Breaking Clinical Trial with simultaneous publication in Lancet. The purpose of this study was to assess whether focal preventative PCI of non-flow limiting VP improves clinical outcomes compared with OMT alone.
This trial randomized patients with a coronary stenosis of >50% and negative fractional flow reserve (FFR >= 0.80) meeting at least 2 of 4 imaging criteria for plaque vulnerability to the intervention arm of preventive PCI + OMT or the control arm of OMT alone. The primary endpoint was target-vessel failure, a composite of death from cardiac causes, target-vessel myocardial infarction, ischemia-driven target-vessel revascularization, or hospitalization for unstable or progressive angina assessed at 2 years post-randomization.
Overall, 1606 patients were randomized, 803 to each arm. Average age was 65 years, about one quarter were female. Over 83% presented with stable anginal or silent ischemia, and 12% presented with unstable angina. The mean number of VPs per patient was 1. Half of the target lesions were located in the left anterior descending artery. Fifty patients (3%) were lost to follow up.
Compared to OMT alone, preventative PCI plus OMT had significantly lower rates of target vessel failure at 2 years (0.4% vs 0.4%, HR 0.11 [95% CI 0.03-0.36], 0=0.0003) and 7 years (6.5% vs 9.4%, HR 0.54 [0.33-0.87], p=0.0097). There were also significantly lower rates of the patient-oriented composite outcome of death from any cause, any myocardial infarction, or any revascularization in the intervention arm (14.4% vs. 19.3% HR 0.69 [0.50-0.95], p =0.022).
Limitations include an open-label design, raising concern for placebo effects and ascertainment bias, and lower than expected rates of target vessel failure in both groups, which may be related to the use of intravascular imaging to perform the PCI leading to reduced event rates, as well as excellent overall risk factor control in both arms.
Dr. Seung-Jung Park, from the University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea, concluded: “In the PREVENT trial, preventive PCI plus OMT resulted in a lower incidence of major adverse cardiac events compared with OMT alone in patients with non-flow-limiting vulnerable plaques. Our key findings might provide novel insights on the role of preventive PCI on non-flow-limiting high-risk vulnerable plaques in the future.”