Σεμινάριο Ομάδων Εργασίας Fractional Flow Reserve (FFR) Σε ποιούς ασθενείς; ΔΗΜΗΤΡΗΣ ΑΥΖΩΤΗΣ Επιστ. υπεύθυνος Αιμοδυναμικού Τμήματος, Βιοκλινική

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1 ΕΛΛΗΝΙΚΗΚΑΡΔΙΟΛΟΓΙΚΗΕΤΑΙΡΕΙΑ Σεμινάριο Ομάδων Εργασίας 2011 Fractional Flow Reserve (FFR) Σε ποιούς ασθενείς; ΔΗΜΗΤΡΗΣ ΑΥΖΩΤΗΣ Επιστ. υπεύθυνος Αιμοδυναμικού Τμήματος, Βιοκλινική

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3 GUIDELINES ON MYOCARDIAL REVASCULARIZATION: THE TASK FORCE ON MYOCARDIAL REVASCULARIZATION OF THE EUROPEAN SOCIETY OF CARDIOLOGY (ESC) AND THE EUROPEAN ASSOCIATION FOR CARDIO-THORACIC SURGERY (EACTS). Eur. Heart. 2010;31: Impact of ischaemic burden on prognosis The adverse impact of demonstrable ischaemia on clinical outcome [death, myocardial infarction (MI), ACS, occurrence of angina] has been well recognized for over two decades.(1,2) While symptomatic patients with no or little evidence of ischaemia have no prognostic benefit from revascularization, asymptomatic patients with a significant mass of ischaemic myocardium do. (1,2) 1. Hachamovitch R et al. Circulation 2003;107: Davies RF et al. Circulation 1997; 95:

4 NON- INVASIVE STRESS TESTING AND PCI 100 consecutive patients undergoing PCI at Stanford University School of Medicine (7-8/2001 Courtesy of W.F. Fearon, MD) 100 consecutive patients undergoing PCI at the Cardiovascular Center Aalst, Belgium (7-8/2001 Courtesy of E. Barbato, MD)

5 AHA SCIENTIFIC STATEMENT: Physiological Assessment of Coronary Artery Disease in the Cardiac Catheterization Laboratory Circulation 2006;114: An FFR <0.75 identified coronary stenoses in patients with inducible myocardial ischemia with: HIGH SENSITIVITY (88%) SPECIFICITY (100%) POSITIVE PREDICTIVE VALUE (100%) AND OVERALL ACCURACY (93%).

6 The DEFER Study: Objectives Primary objective to test safety of deferring PCI of stenoses not responsible for inducible ischemia as indicated by FFR > 0.75 ( outcome ) Secondary objective to compare quality of life in such patients, whether or not treated by PCI (CCS-class, need for anti-anginal anginal drugs) ( symptoms )

7 The DEFER Study: Flow Chart Patients scheduled for PCI without Proof of Ischemia (n=325) Randomization deferral of PTCA (167) performance of PTCA (158) FFR 0.75 (91) FFR < 0.75 (76) FFR < 0.75 (68) FFR 0.75 (90) No PTCA PTCA PTCA PTCA DEFER Group REFERENCE Group PERFORM Group

8 EVENT FREE SURVIVAL (%) Defer Perform Reference (FFR < 0.75) p=0.52 p=0.17 p= Years of Follow-up No. at risk Defer group Perform group Reference gr

9 CARDIAC DEATH AND ACUTE MI AFTER 5 YEARS 20 % P=0.20 P< 0.03 P< DEFER PERFORM REFERENCE FFR > 0.75 FFR < 0.75

10 The DEFER Study: Diameter Stenosis versus FFR DS % FFR 0.75 FFR < 0.75

11 DEFER: CONCLUSIONS In patients with stable chest pain, the most important prognostic factor of a given coronary artery stenosis, is its ability of inducing myocardial ischemia (as reflected by FFR < 0.75) The prognosis of non-ischemic stenosis (FFR > 0.75) is excellent. The risk of such non-significant stenosis or plaque to cause death or AMI is < 1% per year, and not decreased by stenting!

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14 FAME STUDY:BACKGROUND Results of DEFER study. In multivessel coronary disease (MVD) identifying which stenoses cause ischemia is difficult. Non invasive tests are often unreliable in MVD. Coronary angiography often results in both under- or overestimation of functional stenosis severity.

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19 FAME STUDY:CONCLUSIONS Routine measurement of FFR during DES-stending in patients with multivessel disease is superior to current angiography guided treatment It improves outcome of PCI significantly. It supports the evolving paradigm of Functionally Complete Revascularization, i.e. Stenting of ischemic lesions and medical treatment of non-ischemic ones.

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22 FREEDOM FROM ANGINA (%)

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25 CONCLUSIONS At 2 years, there is now a significant decrease in the rate of MI in the FFR-guided arm. There continues to be a significant decrease in death and MI favoring the FFR-guided approach. Lastly, there is a strong trend towards a lower rate of death, MI or the need for repeat revascularization in the FFR-guided arm. There is no signal to suggest that deferred lesions are likely to be responsible for late myocardial infarctions or to progress and require repeat revascularizations.

26 ANGIOGRAPHIC SEVERITY VERSUS FUNCTIONAL SEVERITY OF CORONARY ARTERY STENOSES Box-and-whisker plot showing the (FFR) values of all lesions in the categories of 50% to 70%, 71% to 90%, and 91% to 99% diameter stenosis. The red horizontal line corresponds to the FFR cutoff value of 0.80, for myocardial ischemia Pim AL Tonino et al. J Am Coll Cardiol, 2010; 55:

27 RECOMMENDATIONS FOR USE OF FRACTIONAL FLOW RESERVE 2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention: A Report of the American College of Cardiology. J. Am. Coll. Cardiol. 2009;54;

28 INDICATIONS FOR REVASCULARIZATION IN STABLE ANGINA OR SILENT ISHAEMIA ESC & EACTS 2010 Eur. Heart. 2010;31:

29 GUIDELINES ON MYOCARDIAL REVASCULARIZATION: THE TASK FORCE ON MYOCARDIAL REVASCULARIZATION OF THE EUROPEAN SOCIETY OF CARDIOLOGY (ESC) AND THE EUROPEAN ASSOCIATION FOR CARDIO-THORACIC SURGERY (EACTS). Eur. Heart. 2010;31: Invasive tests In common practice, many patients with intermediate or high pretest CAD likelihood are catheterized without prior functional testing. When non-invasive stress imaging is contraindicated, non-diagnostic, or unavailable, the measurement of FFR or coronary flow reserve is helpful. Even experienced interventional cardiologists cannot predict accurately the significance of most intermediate stenoses, on the basis of visual assessment or quantitative coronary angiography. Deferral of PCI or CABG in patients with FFR >0.80 is safe and clinical outcome is excellent. Thus, FFR is indicated for the assessment of the functional consequences of moderate coronary stenoses when functional information is lacking Recognizing that visual attempts to estimate the severity of stenoses on angiography may either under- or overestimate the severity of lesions, the increasing use of FFR measurements to identify functionally more important lesions is a significant development

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36 RIGHT CORONARY ARTERY OF A 66-YEAR-OLD MAN WITH RECURRENT ANGINA WHO HAD STENT IMPLANTATION IN THE MID-RIGHT CORONARY ARTERY 1 YEAR PREVIOUSLY AND NOW HAS A POSITIVE NUCLEAR SCAN IN THE INFERIOR WALL The right coronary artery shows diffuse disease with 5 stenoses of intermediate severity (arrows) MJ Kern et al.circulation. 2006;114:

37 RIGHT CORONARY ARTERY OF A 66-YEAR-OLD MAN WITH RECURRENT ANGINA MJ Kern et al.circulation. 2006;114:

38 DISTRIBUTION OF THE STUDY POPULATION OVER THE 5 FFR CATEGORIES Strong inverse correlation between FFR after stenting and event rate at 6- month follow-up. Nico HJ Pijls et al. Circulation 2002;105:

39 CORONARY ANGIOGRAMS, SIMULTANEOUSLY OBTAINED AORTIC (P A ) AND DISTAL CORONARY (P D ) PRESSURES, AND IVUS IMAGES Angiogram and pressure tracings before intervention. Coronary angiogram, IVUS images, and pressure recordings after stent inflation with 8 atm. Clara EE Hanekamp. et al. Circulation 1999;99:

40 CORONARY ANGIOGRAMS, SIMULTANEOUSLY OBTAINED AORTIC (P A ) AND DISTAL CORONARY (P D ) PRESSURES, AND IVUS IMAGES DURING SUCCESSIVE STEPS OF PROTOCOL IN 49-YEAR-OLD MAN Coronary angiogram, IVUS images, and pressure recordings after stent inflation with 10atm. Coronary angiogram, IVUS images, and pressure recordings after stent inflation with 12 atm. Clara EE Hanekamp. et al. Circulation 1999;99:

41 FRACTIONAL FLOW RESERVE AND ANGIOGRAPHIC PERCENT STENOSIS IN JAILED SIDE BRANCHES The optimal cutoff value for percent stenosis to predict functionally significant stenosis was 85% (sensitivity, 0.8; specificity, 0.76), yielding an area under the curve of 0.85 (95% confidence interval, 0.76 to 0.94) BK Koo et al. J Am Coll Cardiol Aug 16;46(4):633-7