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 long-term clinical outcomes supports FFR to identify ischemia-producing lesions and shows improved outcomes over angio-guided procedures alone.
An FFR cutoff of ≤0.80 is most commonly used in clinical studies. 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.
POLARIS Software - FFR Demo Video

POLARIS Software – FFR Demo

View the unique features and intuitive workflow of our POLARIS FFR software, designed in partnership with clinicians.  

Hard Endpoints Favor FFR-Guided Strategy vs Medical Therapy Alone: A Pooled, Patient-Level Analysis of FAME II, DANAMI-3-PRIMULTI, and COMPARE-ACUTE1

Pooled analysis of 2,400 patients with stable CAD enrolled in FAME II, DANAMI-3-PRIMULTI & COMPARE-ACUTE were 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

FFR Guided 1-Year Outcomes

DEFER Trial2

Using fractional flow reserve (FFR) to determine the suitability of angioplasty in moderate coronary stenosis, this study found that measuring FFR in patients with a coronary stenosis referred for PTCA without objective evidence of ischemia can help identify those for whom the treatment is most appropriate. In patients with an FFR of >0.75, PTCA did not improve outcomes compared to medical therapy alone.

FAME Trial3

1,005 patients with multi-vessel coronary artery disease (CAD) were randomized to undergo PCI with drug-eluting stents, guided by angiography alone or angiography with fractional flow reserve (FFR). The trial found that patients in the FFR-guided arm had a significantly reduced rate of the composite endpoint of death, nonfatal myocardial infarction, and repeat revascularization at one year compared to angiography alone (13.2% vs 18. 3%).

FAME II Trial4

FAME II investigated the outcomes of patients with stable coronary artery disease (CAD) treated by FFR-guided PCI and medical therapy vs medical therapy alone, FFR-guided PCI plus medical therapy was found to decrease the need for urgent revascularization compared to the medical therapy alone. The study was terminated early due to the strong evidence showing superior outcomes for the FFR-guided strategy and thus enabling patients in the medical therapy arm with an FFR of <=0.80 to receive PCI.