Coronary disease & ACSRandomised controlled trial

Outcomes after fractional flow reserve-guided percutaneous coronary intervention versus coronary artery bypass grafting (FAME 3): 5-year follow-up of a multicentre, open-label, randomised trial

LancetPublished

  • Randomised controlled trial
  • multicentre
  • open-label
  • 5-year follow-up
  • final prespecified analysis
  • 5-year follow-up in 724 (96%) percutaneous coronary intervention (PCI) and 696 (94%) coronary artery bypass grafting (CABG)

Authors' conclusion

At the 5-year follow-up, there was no significant difference in a composite outcome of death, stroke, or myocardial infarction after FFR-guided PCI versus CABG, although myocardial infarction and repeat revascularisation were higher with PCI.

Study context

Population
Patients with three-vessel CAD not involving the left main coronary artery; 48 hospitals in Europe, USA and Canada, Australia and Asia
Participants
1,500 patients
Comparison
Fractional Flow Reserve (FFR)-guided PCI vs CABG
  • PCIn = 757
  • CABGn = 743reference
Primary endpoint
Composite of:
  • Death
  • Stroke
  • MI
Follow-up
5 years

Primary result

Death, stroke or MI

Hazard ratio

1.16

95% CI 0.89–1.52

P = 0.27

Events by treatment group

PCI vs CABG
HR 1.16 (95% CI 0.89–1.52); P = 0.27

As reported in the abstract

Further findings

Death · 5 years

0.99 (CI 0.67–1.46)

Stroke · 5 years

0.65 (CI 0.33–1.28)

MI · 5 years · higher with PCI

1.57 (CI 1.04–2.36)

Repeat revascularisation · 5 years · higher with PCI

2.02 (CI 1.46–2.79)

Original publication

Outcomes after fractional flow reserve-guided percutaneous coronary intervention versus coronary artery bypass grafting (FAME 3): 5-year follow-up of a multicentre, open-label, randomised trial. Lancet. Published 30 March 2025. doi:10.1016/s0140-6736(25)00505-7

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