Randomised controlled trial

Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial

LancetPublished

  • Randomised controlled trial
  • multicentre
  • open-label
  • 15 hospitals in 4 countries

Authors' conclusion

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 context

Population
Adults with non-flow-limiting (FFR >0.80) vulnerable coronary plaques identified by intracoronary imaging1,556 (97%) completed 2-year follow-up
Participants
1,606 adults
Comparison
Percutaneous coronary intervention vs Optimal medical therapy alone
  • Percutaneous coronary interventionn = 803
  • Optimal medical therapy alonen = 803reference
Primary endpoint
Composite of:
  • Cardiac death
  • Target-vessel MI
  • Ischaemia-driven target-vessel revascularisation
  • Hospitalisation for unstable or progressive angina (ITT)
Follow-up
2 years

Primary result

As reported in the abstract

Absolute difference

−3.0 percentage points

95% CI −4.4 to −1.8

P = 0.0003

Events by treatment group

PCI vs Optimal medical therapy
absolute difference −3.0 percentage points (95% CI −4.4 to −1.8); P = 0.0003

Further findings

OutcomePercutaneous coronary interventionOptimal medical therapy aloneabsolute difference (percentage points) (95% CI)
Death · 2 years · Serious clinical or adverse events did not differNot reported in the abstract1.3%−0.8 (−1.7 to 0.2)
  • Death: PCI 0.5%

Safety

OutcomePercutaneous coronary interventionOptimal medical therapy aloneabsolute difference (percentage points) (CI)
MI · 2 yearsNot reported in the abstract1.7%−0.5 (−1.7 to 0.6)
  • MI: PCI 1.1%

Original publication

Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial. Lancet. Published 8 April 2024. doi:10.1016/s0140-6736(24)00413-6

Summarised from the published abstract; every number is checked against it