POLARIS

Multi-Modality Guidance System

What is Fractional Flow Reserve (FFR)?

FFR calculates the maximum flow down a vessel in the presence of stenosis compared to maximum flow in the hypothetical absence of the stenosis.
A strong body of clinical evidence supports FFR (fractional flow reserve) usage to identify ischemia producing lesions and shows improved outcomes over angio-guided procedures alone.
POLARIS FFR Software Demo
View the unique features and intuitive workflow of our POLARIS FFR software, designed in partnership with clinicians.  

What is the FFR cutoff?

An FFR reading <= 0.80 is the most often cut off used in clinical studies (FAME). To expect the outcomes of the major clinical studies (FAME, FAME II, etc.) 0.80 with maximum hyperemia should be used. The AUC Guidelines reflect the FAME cutoff of 0.80.

Physicians want to be confident that they are not deferring an ischemic lesion.

FFR-Guided Procedures Improved Outcomes vs. Angio Alone

A strong growing body of clinical evidence supports FFR (fractional flow reserve) in increasingly more diverse patient populations and lesion subsets.

FAME I Study shows FFR-guided procedures improved outcomes vs. Angio Alone.¹

The FAME I Study 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.

Results Overview

  • 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.

Absolute Difference in MACE-Free Survival

Absolute difference in MACE-free survival

1-Year Outcomes

FFR Guided 1-Year Outcomes

FAME II Trial shows deferring ischemic lesions (FFR <= 0.80) leads to worse outcomes.2

  • The FAME II trial enrolled 1220 patients with stable CAD and with an angiographically significant stenosis. Patients with an FFR of more than 0.80 were enrolled into the registry arm and patients with an FFR of <=0.80 were randomized to either PCI+medical therapy or medical therapy alone. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.
  • At 5 years, MACE rates for patients with a hemodynamically significant lesion were 13.9% for PCI vs 27% for medical therapy alone, demonstrating a significant improvement for the PCI arm.
  • There was also a strong signal toward less MI in the PCI arm vs medical therapy alone with rates of 8.1% and 12% respectively.
  • There was no significant difference in the rate of MACE between the PCI and registry group (13.9% and 15.7% respectively).
  • Take-home: FAME II demonstrates the long-lasting positive impact of PCI-guided by FFR and the safe deferral of patients with an FFR of >0.80.

Primary Endpoint
(All cause death, MI, or urgent revascularization)

FAME II - Primary Endpoint (All cause ceath, MI, or urgent revascualrization)

A pooled, patient-level analysis of FAME II, DANAMI-3-PRIMULTI, and COMPARE-ACUTE3

Pooled analysis analysis of 2,400 patients with stable CAD enrolled in FAME II, DANAMI-3-PRIMULTI & COMPARE-ACUTE randomized to an FFR-guided strategy vs medical therapy alone. FFR-guided PCI resulted in a statistically significant reduction of cardiac death or MI at 5 years.

  • The relative risk reduction for cardiac death or MI was 28%
  • The absolute risk reduction for cardiac death or MI is 4.5%
  • FFR-guided PCI was also favored for all-cause death or MI
  • The combined endpoint was driven by reduction in MI

Cardiac Death or Myocardial Infarction

Cardiac Death or Myocardial Infarction
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