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Evevident
Original paper
2009NEJMCardiology

FAME

Fractional Flow Reserve versus Angiography for Guiding Percutaneous Coronary Intervention

RCTCoronary physiology / PCI guidance

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Overview

In multivessel CAD undergoing PCI, FFR-guided PCI used fewer stents and reduced 1-year MACE versus angiography-guided PCI.

Clinical takeaway

FAME established that coronary physiology can outperform visual stenosis severity alone. Measuring FFR reduced unnecessary stenting and improved the composite of death, MI, or repeat revascularization.

Key result

Death, nonfatal MI, or repeat revascularization at 1 year: 13.2% with FFR guidance vs 18.3% with angiography guidance.

Practice impact

Use coronary physiology when lesion significance is uncertain instead of stenting every visually moderate lesion.

Evidence

Study design

Randomized, multicenter, controlled trial.

Enrollment

1,005

Follow-up

1 year.

Geography

United States, Europe

Clinical question

Does FFR-guided PCI improve outcomes compared with angiography-guided PCI in multivessel coronary artery disease?

Population

  • Patients with multivessel coronary artery disease undergoing PCI with drug-eluting stents.

Intervention

FFR-guided PCI, treating indicated lesions only when FFR was 0.80 or less.

Comparator

Angiography-guided PCI based on visual stenosis severity.

Primary outcome

Composite of death, nonfatal myocardial infarction, or repeat revascularization at 1 year.

FFR-guided PCI reduced the 1-year composite event rate compared with angiography-guided PCI.

Event rate / 13.2 / p=0.02

Key results

  • Primary event rate: 13.2% with FFR guidance vs 18.3% with angiography guidance; p=0.02.
  • Mean stents per patient: 1.9 with FFR guidance vs 2.7 with angiography guidance; p<0.001.
  • Freedom from angina at 1 year was similar between groups.

Harms

  • Adenosine used to induce maximal hyperemia for FFR can cause transient dyspnea, flushing, chest discomfort, or heart block.
  • Procedural complication rates were similar between groups; FFR guidance reduced contrast volume and stent use.

Clinical Use

When to cite

  • When explaining why lesion physiology should guide PCI decisions.

Practice impact

  • Made invasive coronary physiology central to deciding which lesions to stent in multivessel disease.

Applicability

  • Most applicable to patients already undergoing PCI evaluation for multivessel CAD with lesions of uncertain physiologic significance.

Limitations

  • Studied patients referred for PCI, not a broad stable-CAD screening population.
  • Stent technology and medical therapy have evolved.
  • FFR requires invasive measurement and maximal hyperemia.

Common misinterpretations

  • Do not use FAME as an argument for routine PCI in all stable CAD; it addresses PCI guidance once PCI is being considered.

Related evidence

FAME 2 - Later TrialISCHEMIA - ContextCOURAGE - Context

Citation

Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-224. doi:10.1056/NEJMoa0807611

Routine measurement of FFR significantly reduces the composite end point at 1 year.