Fractional Flow Reserve: Review of the latest data

Transcription

1 Fractional Flow Reserve: Review of the latest data Michalis Hamilos, MD, PhD, FESC University Hospital of Heraklion

2 Fractional Flow Reserve (FFR) Coronary angiography does not always tell the truth Most of the patients coming to the catheterization laboratory had never a non- invasive test Need for a simple and reliable tool to provide information about the haemodynamic significance of a coronary stenosis This needs to be available inside the cath lab

3 Myocardial Fractional Flow Reserve: Definition Fractional Flow Reserve is a ratio FFR = Q s max max Q N maximal myocardial flow in the stenotic territory normal maximal myocardial flow FFR = extent (%) to which the epicardial stenosis limits maximal myocardial blood flow

4 Myocardial Fractional Flow Reserve: Definition S Q max N Q max = FFR P a P d P v (P d -P v ) / R myo P d -P v FFR = = = S N (P a -P v ) / R myo P a -P v P d P a

5 Fractional Flow Reserve FFR = P distal / P proximal during maximal flow FFR = P d / P a = 49/79 = 0.69

6 Threshold Values of FFR to Detect Significant Stenosis FFR non-signif. stenosis significant FFR < 0.75 always ischaemia (specificity 100 %) FFR > 0.80 ischaemia very unlikely (sensitivity 90 %) Pijls et al, NEJM1996

7 Features of FFR Has a normal value = 1.0 for every patient and every artery Is not influenced by changing hemodynamic conditions Accounts for collaterals Is easy to measure (success rate 99 %) and extremely reproducible Pressure measurement has un unequaled spatial resolution

8 FFR: Trials

9 FFR for Intermediate Lesion Assessment: The DEFER study 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 Bech et al, Circulation 2001

10 FFR for Intermediate Lesion Assessment: The DEFER study FFR > 0.75 FFR > 0.75 Bech et al, Circulation 2001

11 Cardiac Death and Acute MI after 5 years 20 % P=0.20 P< P< DEFER PERFORM REFERENCE FFR > 0.75 FFR < 0.75 Pijls et al, JACC 2007

12 Patient with stenoses 50% in at least 2 of the 3 major epicardial vessels Indicate all stenoses 50% considered for stenting Randomization Angiography-guided PCI FFR-guided PCI Measure FFR in all indicated stenoses Stent all indicated stenoses Stent only those stenoses with FFR year follow-up

13 Assessed for eligibility N=1905 Randomized N=1005 Not eligible N= 900 Left main stenosis N= 157 Extreme coronary tortuosity or calcification N= 217 No informed consent N= 105 Contra-indication for DES N= 86 Participation in other study N= 94 Logistic reasons N= 210 Other reasons N= 31 Angiographyguided PCI N=496 Lost to follow-up N=11 Analyzed N=496 CVTI, London 2010 FFR-guided PCI N=509 Lost to follow-up N=8 Analyzed N=509

14 FAME study: Adverse Events at 1 year ANGIO-group N=496 FFR-group N=509 P-value Events at 1 year, No (%) Death, MI, CABG, or repeat-pci 91 (18.4) 67 (13.2) 0.02 Death 15 (3.0) 9 (1.8) 0.19 Death or myocardial infarction 55 (11.1) 37 (7.3) 0.04 CABG or repeat PCI 47 (9.5) 33 (6.5) 0.08 Total no. of MACE Myocardial infarction, specified All myocardial infarctions 43 (8.7) 29 (5.7) 0.07 Small periprocedural CK-MB 3-5 x N Other infarctions ( late or large ) Tonino et al, NEJM 2009

15 1 Year Results from FAME 1. Improved outcomes 2. Decreased cost Absolute Difference in MACE-Free Survival 3. Less contrast use 4. Similar procedure time FFR-guided PCI Angio FFR Angio-guided PCI 5.3% 360 days p=0.02 $6,007 vs $5,332, p< ml vs 272 ml, p< min vs 71 min, p=0.51 Tonino et al, NEJM 2009

16 FAME: 2 years FU Fearon et al, TCT 2009

17 Adverse Events at 2 Years Angio- Guided n = 496 FFR- Guided n = 509 P Value Total no. of MACE Individual Endpoints Death 19 (3.8) 13 (2.6) 0.25 Myocardial Infarction 48 (9.7) 31 (6.1) 0.03 CABG or repeat PCI 61 (12.3) 53 (10.4) 0.35 Composite Endpoints Death or Myocardial Infarction 63 (12.7) 43 (8.4) 0.03 Death, MI, CABG, or re-pci 110 (22.2) 90 (17.7) 0.07 Fearon et al, TCT 2009

18 274 patients with LMCA 26 patients with protected LMCA 10 patients with valvular disease 213 patients enrolled 4 patients requiring surgery but treated medically 21 patients requiring surgery for other vessel disease 138 Nonsurgical group 75 Surgical group 2 patients lost in FU 2 patients lost in FU 136 patients included in the analysis 73 patients included in the analysis Hamilos et al, Circulation 2009

19 % Survival 5-year Survival p=0.48 FFR 0.80 FFR< No at risk Months FFR FFR< Hamilos et al, Circulation 2009

20 FFR for proximal LAD lesions 852 patients with isolated proximal LAD stenosis 730 patients eligible for the study 546 patients with an FFR 0.80, treated medically 166 patients with an FFR<0.80 treated by revascularization O Muller et al, JACC Interv 2011

21 FFR for proximal LAD lesions 564 patients FFR>0.80, medical 166 patients FFR<0.80, PCI/CABG B P = P = Medical group Revascularization group SURVIVAL at risk >= < Medical group Revascularization group MACE No at risk FFR >= FFR < O Muller et al, JACC Interv 2011

22 FFR for proximal LAD lesions O Muller et al, JACC Interv 2011

23 FAME 2 Stable CAD patients scheduled for 1, 2 or 3 vessel DES-PCI N = 1220 Randomized Trial FFR in all target lesions Registry At least 1 stenosis with FFR 0.80 (n=888) When all FFR > 0.80 (n=332) Randomization 1:1 PCI + MT 73% MT 27% MT 50% randomly assigned to FU Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years

24 FAME 2: Primary Outcomes Cumulative incidence (%) 30 No. at risk MT PCI+MT Registry 0 PCI+MT vs. MT: HR 0.32 ( ); p<0.001 PCI+MT vs. Registry: HR 1.29 ( ); p=0.61 MT vs. Registry: HR 4.32 ( ); p< Months after randomization De Bruyne et al, NEJM 2012

25 Cumulative incidence (%) Cumulative (%) Kaplan-Meier plots of Landmark Analysis of Death or MI days: HR 7.99 ( ); p=0.038 > 8 days: HR 0.42 ( ); p=0.053 p-interaction: p= Days after randomization PCI plus MT MT alone 7 days 5 0 >8 days 07days Months after randomization MT alone PCI plus MT De Bruyne et al, NEJM 2012

26 One Year Cost Estimates Per Patient FFR-Guided PCI MT Baseline $8,790 $3,305 Drug-Eluting Stent(s) $4,304 $48 Follow-up $2,584 $5,561 Revascularization $442 $3,928 Total $11,374 $8,866 Fearon et al, TCT 2012

27 Cumulative Costs over 12 Months $2,508 $5,485 % of study population 100% 56% 11% Fearon et al, TCT 2012

28 Quality of Life at 1 Month Angina (%) FFR-Guided PCI MT p-value Class <0.001 Class <0.001 Utility Change <0.001 Fearon et al, TCT 2012

29 FFR-Guided Strategy & Clinical Outcome STUDY 5 year survival 5 year event free survival DEFER (deferred group) 97% 79% FAME 1-FFR group (2 y) 97% 82% FFR Left Main (deferred group) 90% 74% FFR LAD (deferred group) 92.9% 89.7% FAME 2- Registry (1y) 100% 97% Controls (Rotterdam) 89.6% Risk Factors No disease(4 y)* 91.7% 83.4% * REACH Registry, JAMA 2010

30 Impact of downstream stenoses on LM FFR When FFR LM + FFR LAD >0.65, FFR LM measured is valuable Daniels et al, JACC interv 2012

31 Conclusions FFR is a well studied, simple and reliable means of assessing stenosis functional severity FFR value + anatomical information from angiography give a complete all in one assessment for patients with CAD FFR guided revascularization strategy has strong data to support the safe deferral of non ischemic coronary lesions (FFR>0.80) FFR should be considered as an indispensable imaging modality inside the cath lab