- By 5-year mark, patients with stable coronary artery disease (CAD) and critical stenoses who had undergone fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) required fewer urgent revascularizations than those who received medical therapy.
Why this matters
- Guidelines recommend FFR-guided PCI timing in stable CAD, but few patients undergo testing before PCI.
- FFR group did better in FAME 2 at 7 months; recruitment truncated.
- Median follow-up 60.5 months; 19 sites.
- FFR vs medical-therapy group:
- Composite outcome: 62 (13.9%) vs 119 patients (27.0%) (HR, 0.46; 95% CI, 0.34-0.63; P<.001>
- Difference driven by fewer urgent revascularizations with FFR.
- Death, myocardial infarction (MI) rates similar.
- Fractional Flow Reserve vs Angiography for Multivessel Evaluation (FAME) 2: 28-site randomized trial.
- 888 patients with stable CAD and ≥1 vessel with FFR ≤0.80 randomly assigned to FFR-guided PCI vs medical therapy.
- 332 additional patients without critical stenosis followed in registry.
- Composite primary outcome: all-cause mortality, MI, urgent revascularization.
- Funding: St. Jude Medical.
- Early termination can exaggerate treatment effect.
- Intention-to-treat analysis could underestimate effect, as many medical-therapy patients crossed over to PCI.
- Not all sites participated in follow-up.