Long-term follow-up from the FAMOUS-NSTEMI trial suggests that a fractional flow reserve-guided strategy for managing patients with non-ST-segment elevation myocardial infarction (NSTEMI) does not reduce adverse cardiovascular outcomes compared to standard angiography-guided care.¹

Methodology

FAMOUS-NSTEMI was a prospective, randomised, controlled trial that enrolled 350 patients with NSTEMI across six hospitals in the UK. Participants were randomised on a 1:1 basis to receive either fractional flow reserve (FFR)-guided management or standard angiography-guided care. In the FFR-guided arm, a value of ≤0.80 was an indication for revascularisation by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

The prespecified primary outcome for this long-term analysis was the incidence of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death or hospitalisation for myocardial infarction or heart failure.¹

Results

After a median follow-up of 9.3 years, no significant difference was observed in the primary MACE outcome between the two groups. A MACE event occurred in 28.0% of patients in the FFR-guided group compared with 23.3% in the angiography-guided group (hazard ratio [HR] 1.26; 95% CI 0.82, 1.95; P=0.288).

The analysis revealed a higher rate of cardiovascular death in the FFR-guided group (HR 2.05; 95% CI 0.99, 4.26; P=0.054), which was statistically significant in the Kaplan-Meier analysis (P=0.049). A non-significant trend towards higher all-cause mortality was also seen in the FFR-guided arm (HR 1.47; 95% CI 0.94, 2.30; P=0.094).

Rates of coronary revascularisation with PCI or CABG after the index hospital discharge were not significantly different between the FFR-guided and angiography-guided groups (16.1% vs 22.7%; HR 0.72; 95% CI 0.43, 1.18; P=0.193).¹

In Practice

The 10-year results of the FAMOUS-NSTEMI trial do not support the routine use of FFR to guide revascularisation decisions in patients presenting with NSTEMI. The findings are consistent with current clinical guidelines that generally advise against functional assessment of a culprit lesion during the index procedure in acute coronary syndromes.¹˒² These results underscore the complexities of culprit lesion identification and the potential limitations of FFR in the acute NSTEMI setting.

Next Steps

Further insights into optimal revascularisation strategies for patients with NSTEMI are expected from ongoing clinical trials, including Complete-NSTEMI (NCT05786131) and COMPLETE-2 (NCT05701358).

This study was funded by the British Heart Foundation and Abbott Vascular.

References

1. Berry C, Stanley B, Duklas P, et al. Fractional flow reserve vs angiography in non-ST- elevation myocardial infarction: long-term results of the FAMOUS-NSTEMI trial. Eur Heart J. 2026;47(12):1487-1490. https://doi.org/10.1093/eurheartj/ehaf925

2. Layland J, Oldroyd KG, Curzen N, et al. Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial. Eur Heart J. 2015;36:100-11. https://doi.org/10.1093/eurheartj/ehu338

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