Multi-vessel Disease

  

Ensure cost-efficiency in your Multi-vessel Disease cases

  • Multi-vessels coronary artery disease (CAD) is a disease stage in which at least two or three of the epicardial coronary arteries is involved with atherosclerosis of significant severity
  • The goal in the treatment of multi-vessel disease is to reduce angina and heart failure symptoms
  • The FAME study demonstrated that routine measurement of FFR (Fractional Flow Reserve) during DES-stenting in patients with multi-vessel disease is superior to current angiography guided treatment and improves outcome of PCI significantly

FFR Clinical Information

In FAME I and FAME II, FFR-Guided Procedures Saved the Hospital Money and Improved Outcomes vs. Angio Alone.

  • A strong growing body of clinical evidence supports FFR in increasingly more diverse patient populations and lesion subsets.
  • Courage Trial showed that non-discriminatory stenting without regard for ischemia does not improve outcomes.
  • Defer Trial showed that deferring patients with FFR ≥ 0.75  improved outcomes.
  • FAME I study demonstrated that FFR-guided stenting (FFR < 0.8) vs. only angio-guided stenting significantly improved outcomes.
  • FAME II study illustrated that PCI was superior to medical therapy with FFR < 0.8.
  • Both FAME I and II stated that FFR was economical compared to other standards of care and lowered costs within 1 year compared to angiography alone.

FAME I

FFR-guided procedures improved outcomes over angio-guided procedures.

  • FAME I evaluated angio-guided PCI vs. FFR-guided PCI.
    • Lesions identified by angio requiring PCI randomized into two groups:  Angio-guided vs. FFR-guided.
    • FFR < 0.80 was used as the cutoff.
  • The FFR group performed significantly better in MACE-free survival 30–360 days.
  • The FFR group was statistically significant in Death/MI and MACE but improved in all metrics vs. the angio-guided group.

MACE-free Survival

FFR-guided procedures improved outcomes over angio-guided procedures.

Absolute difference in MACE-free survival

FFR-guided procedures improved outcomes over angio-guided procedures.

1-year Outcomes

FAME II

Deferring ischemic lesions (FFR < 0.8) lead to worse outcomes.

  • FAME II randomized patients with FFR < 0.8 to PCI + MT* or MT compared to patients with FFR > 0.8 who received MT.
    • The goal of the study was to assess if MT alone was superior in ischemic lesions.
    • The trial was stopped early due to the statistically significant poor performance of the MT group.
  • 83% Relative risk reduction in urgent revascularization in FFR PCI+MT group.

Death, MI, Revascularization

FFR-Guided PCI & MT

Urgent revascularization driven by MI or unstable angina with ECG changes.

                

FFR Cutoff

FFR < 0.80 is the cutoff used in most clinical studies (FAME).

  • FFR < 0.75 was validated against the 3 gold standard tests to correlate with ischemia with 100% specificity.
  • FFR between 0.75 and 0.80 may indicate ischemia.
  • FFR > 0.80 is highly likely to be non-ischemic.
  • Physicians want to be confident that they are not deferring an ischemic lesions ➔ 0.80 is the most often cut off used in clinical studies.
  • AUC Guidelines reflect the FAME cutoff of 0.80.
  • To expect the outcomes of the major clinical studies (FAME, FAME II, etc.) 0.80 with maximum hyperemia should be used.



FFR Economic Value

Multi-Vessel Disease Savings

FFR-guided procedures improved outcomes and reduced costs.
Savings of $2,385/patient over one year in patients with multi-vessel disease.



Improved Health Outcomes Reduced Costs

Improved health outcomes and accurate diagnosis lead to reduced costs.
FFR use demonstrated improved overall health outcomes at one year with less MACE, MI and death.

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