What is FFR？
FFR (Fractional Flow Reserve) is a lesion specific, physiological index determining the hemodynamic severity of intracoronary lesions.
FFR can accurately identify lesions responsible for ischemia that may be undetected or assessed incorrectly by imaging technologies in many cases. When the ischemic significance of a stenosis is uncertain, FFR can be used as an index to analyze whether PCI is beneficial to patients.
What are the advantages of FFR-guided PCI compared with conventional Angiography-guided PCI?
The FAME（Fractional Flow Reserve versus Angiography for Multivessel Evaluation）Study was designed to demonstrate whether patients with multivessel disease had better outcomes with FFR-guided PCI compared to Angiography-guided PCI. In this study, a total of 1,005 patients with multivessel CAD were randomized to undergo angiography-guided PCI or FFR-guided PCI.
The study result showed that Angiography-guided PCI involved the stenting of all indicated lesions, and FFR-guided PCI involved the stenting of lesions with FFR measurements ≤0.80. The number of stents used per patient was significantly different between the two groups, with 2.7 used in the Angiography group and 1.9 used in the FFR group (P<0.001).<>
At 1-year after stenting, patients in the FFR group experienced obviously less subsequent event (death, nonfatal MI or repeat revascularization) compared with patients in Angiography group（13.2% vs. 18.3%, P=0.02）. (N Engl J Med. 2009;360(3):213-24. – http://www.sciencedirect.com/science/article/pii/S0735109710016025)
The follow-up data demonstrate the benefit of FFR measurement in patients with multivessel CAD. When FFR is used prior to PCI, patient outcomes are improvedand unnecessary stenting is also prevented. (J Am Coll Cardiol. 2010;56(3):177-84. - http://www.sciencedirect.com/science/article/pii/S0735109710016025)
Whether FFR-guided PCI plus medical treatment is more effective than medical treatment alone in patients with stable coronary artery?
The FAME 2 Study was designed to investigate the outcomes of stable angina patient sreceiving FFR-guided PCI compared with patients who received optimal medical therapy alone. The study was designed to assess whether FFR-guided PCI would result in improved outcomes for a composite endpoint of death, MI or urgent revascularization. (De Bruyne B, Pijls NH, Kalesan B, et al. Fractional flowreserve-guided PCI versus medical therapy in stable coronary disease. N Engl JMed. 2012;367(11):991-1001.) – http://www.nejm.org/doi/full/10.1056/NEJMoa1205361)
The study result showed that patients in the medical therapy group showed a significantly higher need for urgent revascularization, compared to patients in the FFR group (11.1 % vs. 1.6 %, P<0.001). And patients in the medical therapy group were also more likely to have revascularizations triggered by MI or evidence of ischemia (P<0.001).<>
Whether FFR can be used as an effective follow-up index for patients with stable chest pain but functionally non-significant coronary stenosis justified?
The DEFER study indicated that the outcomes of patients referred for PTCA (Percutaneous Transluminal Coronary Angioplasty）without objective proof of ischemia might vary depending on the severity of coronary stenosis detected by FFR.
In patients with FFR scores ≥0.75, PTCA did not appear to improve patient outcomes compared to medical treatment alone. Later 5-year follow-up of DEFER patients showed that these outcomes were maintained over time.
Five-year outcome after deferral of PCI of an intermediate coronary stenosis based on FFR 0.75 is excellent.
(J Am Coll Cardiol 2007;49:2105-11) © 2007 by the American Collegeof Cardiology Foundation - http://content.onlinejacc.org/article.aspx?articleid=1138219)
Whether the conventional FFR assessment method has some defects?
The conventional FFR (Fractional Flow Reserve) assessment methods have shortcomings, including wedging, drifting, the problem of connection and equalization, complexity of the implementation process and relatively high operation time requirements, etc. These problems hinder wide application of FFR despite its strong evidence showing its benefits in lowering MACE (Major Adverse Cardiac Events) and cost.
What are the advantages of CAFFRTM?
The main purpose of our products is to further reduce the occurrence of MACE. Compared with conventional FFR assessment methods, CAFFRTM FlashAngioTM System has many significant advantages.
ü By using enhanced Computerized Flow Dynamic (CFD) approach, the system provides >96% accuracy.
ü Dedicately designed CFD algorithm provides resolution to Navier–Stokes formula in 30 seconds.
ü FlashPressureTM provides exceptional correlation and accuracy in critical section.
ü Our real-time biosensor can generate comprehensive analysis of physiological parameters in all stages of the cardiac cycle.