FAME 2
Fractional flow reserve versus Angiography for Multivessel Evaluation 2
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 888 patients with stable coronary disease and a functionally significant (FFR ≤0.80) stenosis, FFR-guided PCI plus medical therapy reduced death, MI, or urgent revascularisation compared with medical therapy alone.
N
888
Schéma
Multicentre open-label RCT, stopped early for benefit
Critère
Death from any cause, nonfatal MI, or urgent revascularisation
Pertinence
3
RésultatPCI 4.3% vs medical therapy 12.7% (HR 0.32, 95% CI 0.19-0.53, P<0.001), driven by reduction in urgent revascularisation; no significant difference in death or MI at this early timepoint.
De Bruyne B, et al. N Engl J Med. 2012;367(11):991-1001. 10.1056/NEJMoa1205361
Discussion et critique
Composite driven by the softer, unblinded urgent-revascularisation component and the trial stopped early, which can inflate effect size. Established FFR-guided PCI over medical therapy for functionally significant stable lesions.