Fractional Flow Reserve (FFR) and CathWorks FFRangio™ System Clinical Data Overview

FFR in Clinical Guidelines

Clinical guidelines provide insights into FFR efficacy.

Governing Body and Scope Guidance  
2011 ACCF/AHA/SCAI
Guideline for Percutaneous Coronary Intervention
  • FFR is reasonable to assess angiographic intermediate coronary lesions (50-70% diameter stenosis) and can be useful for guiding revascularization decisions in patients with stable ischemic heart disease (SIHD). (Class lla, Level of Evidence A).
 
2014 ESC/EACTS
Guidelines On Myocardial Revascularization
  • Deferral of PCI or coronary artery bypass graft in patients with FFR >0.80 appears safe.
  • FFR measurement is indicated for the assessment of the functional consequences of moderate coronary stenosis.
  • FFR-guided PCI with medical therapy has been shown to decrease the need for urgent revascularization compared with the best available medical therapy alone.
 
ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2016
Appropriate Use Criteria for Coronary Revascularization in Patients With Acute Coronary Syndromes
  • In the presence of an asymptomatic intermediate-severity non-culprit artery stenosis, revascularization was rated as “appropriate therapy,” provided that the FFR was ≤0.80.
 
ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017
Appropriate Use Criteria for Coronary Revascularization in Patients With Stable Ischemic Heart Disease
  • Invasive measurements (such as FFR) may be very helpful in further defining the need for revascularization and may substitute for stress test findings.
  • FFR ≤0.80 is abnormal and is consistent with downstream inducible ischemia.
  • Appropriate use criteria advocate for expanded use of intracoronary physiological testing.
 

FFR in Studies

Read our library of publications to see how FFR and CathWorks FFRangio System-guided PCI decision-making is practical and beneficial.

Case Report of First Angiography-Based On-Line FFR Assessment during Coronary Catheterization

This first-in-man procedure report demonstrated that for the first time a coronary case utilizing the CathWorks FFRangio™ System, showing good concordance with the wire-based FFR in sequential lesions of the LAD both before and after stenting. The system allowed for comprehensive functional evaluation of the vessel without the need for drug-induced hyperemia and/or fragmentation of the measurements, as required using conventional invasive FFR.

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Validation Study of Image-Based Fractional Flow Reserve During Coronary Angiography

This study showed that there is high concordance between FFRangio and invasive FFR. The color-coded display of FFR values during coronary angiography facilitates the integration of physiology and anatomy for decision-making on revascularization in patients with stable coronary artery disease.

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FAME Trial

The F.A.M.E. trial data was published in the New England Journal of Medicine in 2009 and compared PCI-decision making between coronary angiography alone versus FFR (wire) in 1,005 randomized patients. Published data clearly demonstrated that FFR-guided PCI decision-making reduced unnecessary stent usage, the number of stents used, the average cost-per-procedure, and MACE at one-year.

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FAME II Trial

The F.A.M.E. II trial data was published in the New England Journal of Medicine in 2012. Enrollment was halted after 1,220 patients with FFR ≤0.80 were randomized to PCI or medical therapy. Published data clearly demonstrated that among patients with stable CAD with FFR ≤0.80, PCI reduces the composite rate of death, nonfatal MI, and urgent revascularization, compared to OMT alone, driven primarily by a reduction in urgent revascularization.

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FAME II Trial 3 Year Follow-up

Three-year follow up data of the F.A.M.E. II trial patients was published in Circulation in November 2017. The publication noted that PCI of lesions with reduced fractional flow reserve improves long-term outcome and is economically attractive compared with MT (medical therapy) alone in patients with stable coronary artery disease.

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