Fractional flow reserve-guided PCI vs medical therapy for stable CAD: FAME 2 at 5 years

  • Xaplanteris P & al.
  • N Engl J Med
  • 22 May 2018

  • curated by Jenny Blair, MD
  • Clinical Essentials
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Takeaway

  • 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.

Key results

  • 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.
  • Patients with FFR >80% treated medically had similar composite-outcome rates as PCI group.

Study design

  • 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.

Limitations

  • 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.

Additional information

  • On May 22 at EuroPCR 2018, pooled patient-level analysis of FAME 2, DANAMI-3-PRIMULTI, and COMPARE-ACUTE found lower death/MI with FFR-guided PCI vs medical therapy, according to PCR press release.
  • Difference driven by fewer MIs.
  • Absolute risk reduction 4.5% at 5 years.

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