Coronary disease & ACSSecondary analysis
Fractional flow reserve-guided percutaneous coronary intervention versus medical therapy for stable coronary artery disease: long-term results of the FAME 2 trial
- Long-term follow-up of the FAME 2 randomised controlled trial
- multicentre
- Sixteen hospitals participated in the long-term follow-up
Authors' conclusion
During long-term follow-up, FFR-guided PCI in patients with stable CAD and hemodynamically significant stenoses reduced the composite of death, myocardial infarction or urgent revascularization, primarily because of fewer urgent revascularizations.
Study context
- Population
- Patients with stable coronary artery disease (CAD) and hemodynamically significant stenoses (fractional flow reserve (FFR) ≤ 0.80)748 in long-term follow-up
- Participants
- 447 vs 441
- Comparison
- FFR-guided percutaneous coronary intervention (PCI) plus medical therapy vs medical therapy alone
- PCIn = 447
- Medical therapyn = 441reference
- Primary endpoint
- Composite of:
- Death
- MI
- Urgent revascularization
- Follow-up
- Median 11.2 years
Primary result
As reported in the abstract
median 11.2 years
PCI vs Medical therapyWin ratio (95% CI)P value
ties 47.5%
1.25(1.01–1.56)
P = 0.043PCI vs Medical therapyWin difference (95% CI)
PCI
5.9%(0.2–11.6)
- PCI
- NNT 17 (95% CI 9–500)
Further findings
Components of the primary endpoint (win ratios) · median follow-up 11.2 years
- All-cause death, win ratio
- 0.88 (95% CI 0.66-1.17)
- MI, win ratio
- 1.50 (95% CI 0.98-2.31)
- Urgent revascularization, win ratio
- 4.57 (95% CI 2.53-8.24)
Original publication
Fractional flow reserve-guided percutaneous coronary intervention versus medical therapy for stable coronary artery disease: long-term results of the FAME 2 trial. Nat Med. Published 15 January 2026. doi:10.1038/s41591-025-04132-5
Summarised from the published abstract; every number is checked against it