The PREVENT Study Overview

A multi-center, open-label randomized controlled trial to evaluate the clinical value of preventative PCIs + OMT vs. OMT alone.

Key Takeaway

In patients with non-flow-limiting vulnerable coronary plaques, preventive percutaneous coronary intervention reduced major adverse cardiac events arising from high-risk vulnerable plaques, compared with optimal medical therapy alone.

Study Summary

Acute coronary syndrome and sudden cardiac death are often caused by the rupture of non-flow limiting lipid rich plaques (LRP). The PREVENT study aimed to evaluate the effectiveness of preventative PCIs plus optimal medical therapy (OMT) vs. OMT alone in the reduction of coronary events. A total of 1,606 patients were randomized into two groups (percutaneous coronary intervention or optimal medical therapy alone) at 15 centers and followed for 2 years. View Article

The primary outcome was a combination of:

  • Death from cardiac causes
  • Target-vessel myocardial infarction
  • Ischaemia-driven target-vessel revascularisation
  • Hospitalization for unstable or progressive angina
Non-Culprit Vulnerable Plaque Definition FFR negative + 2 of the following criteria1:
  1. Large LRP on NIRS (mxLCBI4mm>315)
  2. Plaque Burden > 70%
  3. MLA < 4mm2
  4. TCFA detected by RF-IVUS or OCT

Study Results

Primary outcome assessment was completed in 1,606 (97%) patients of which 780 underwent a percutaneous coronary intervention and 776 had optimal medical therapy.

At 2 years, less MACE occurred in:

patients in the OMT only group (3.4%)
27
patients in the preventative PCI + OMT group (0.4%) 
3

  p=0.0003

Patients were followed up for a maximum of 7-9 years
Chart: Primary Composite Outcome: Target Vessel Failure at 7 Year F/U

The effect of preventive percutaneous coronary intervention was directionally consistent for other components of the primary composite outcome but not statistically significant.

Cardiac Deaths


4(0.5%)
vs
10(1.3%)

Conclusion

3 out of the 4 criteria used to define VP can be measured with
The Makoto Imaging System

In patients with non-flow-limiting vulnerable coronary plaques, preventive percutaneous coronary intervention reduced major adverse cardiac events arising from high-risk vulnerable plaques, compared with optimal medical therapy alone.

View the TCTMD discussion with Dr. Ziad Ali, Dr. J Dawn Abbott, and Mamas A. Mamas BMBCh, DPhil at ACC 2024.

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View the PREVENT Study in The Lancet

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References

1. Park SJ et al. Preventative Percutaneous Coronary Intervention versus Optimal Medical Therapy Alone for the Treatment of Vulnerable Atherosclerotic Coronary Plaques (PREVENT): a Multicentre, Open-label, Randomized Controlled Trial; https://doi.org/10.1016/S0140-6736(24)00413-6

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