Journal : Evidence Review PCI : Role of FFR Dr Binjo J
Vazhappilly SR Cardiology MCH Calicut
Slide 2
FFR is defined as the ratio of flow in stenotic artery to flow
in same artery in the absence of stenosis. FFR is calculated as the
ratio of mean pressure distal (Pd) to stenosis to Aortic pressure
(Pa ), during maximal hyperemia.
Slide 3
Validation studies of FFR Author n Ischemic Test BCV Accuracy
Pijls et al 60 X-ECG 0.74 97 DeBruyne et al. 60 X-ECG/SPECT 0.72 85
Pijls et al 45X-ECG/SPECT/DSE 0.75 93 Bartunek et al 37 DSE 0.68 90
Abe et al 46 SPECT 0.75 91 Chamuleau et al 127 SPECT 0.74 77 Caymaz
et al. 40 SPECT 0.76 95 Jimenez-Navarro et al 21 DSE 0.75 90 Usui
et al 167 SPECT 0.75 79 Yanagisawa et al 167 SPECT 0.75 76
Meuwissen et al 151 SPECT 0.74 85 DeBruyne et al 57 MIBI-SPECT
post-MI 0.78 85 Samady et al 48 MIBI-SPECT post-MI 0.78 85 JACC
Vol. 55, No. 3, 2010
Slide 4
2011 ACC/AHA/SCAI Guideline for PCI Class II a FFR is
reasonable to assess angiographic intermediate coronary lesions
(50% to 70% diameter stenosis) and can be useful for guiding
revascularization decisions in patients with Stable IHD.
Slide 5
FFR in SCAD : 2013 ESC guidelines
Slide 6
DEFER study Aim : To investigate whether FFR discriminates pts
in whom PTCA is appropriate among pts referred for PTCA, without
documented ischemia. Primary end point : Absence of adverse cardiac
events ( all-cause mortality, MI, CABG, coronary angioplasty),
during 24 months of follow-up. Study done in multiple centers in
Netherlands, Spain, Belgium, Germany, South korea, Japan. 5 year
follow-up also done. Circulation 2001;103:2928-2934 G. Jan Willem
Bech, MD; Bernard De Bruyne, MD, PhD; Nico H.J. Pijls MD et al
Slide 7
DEFER Group REFERENCE Group PERFORM Group DEFER Study: Flow
Chart Patients scheduled for PCI without Proof of Ischemia (n=325)
Performance of PTCA (158) Deferral of PTCA (167) FFR 0.75 (91) No
PTCA FFR 0.75 (90) PTCA FFR < 0.75 (76) PTCA FFR < 0.75 (68)
PTCA Randomization
DEFER study conclusions Compared with medical treatment, PTCA
in pts with FFR > 0.75 did not reduce adverse cardiac events or
improvement in functional class. In pts with FFR < 0.75, PTCA
resulted in significant improvement in functional class. Lesions at
greatest risk of causing cardiac death or AMI are those that are
functionally significant ( FFR < 0.75) and risk persists even
after PCI.
Slide 14
Outcomes after FFR based deferral of coronary intervention in
intermediate coronary lesions Author n Defer value MACE(%) Follow
up (months) Hernandez Garcia et al 43 0.75 12 11 Bech et al 60 0.75
12 24 Rieber et al 47 0.75 13 12 Chamuleau et al 92 0.75 9 12
Rieber et al 24 0.75 8 12 Leesar et al 34 0.75 9 12 Bech et al 100
0.75 8 18
Slide 15
FAME (FFR Vs Angiography for Multivessel Evaluation) Study In
the FAME Study, 1005 patients with multivessel CAD were randomly
assigned to FFR-guided PCI or angiography-guided PCI with DES and
followed for one year. Primary end point was rate of major adverse
cardiac events at 1 yr : composite of death, MI and repeat
revascularization. Randomised multicenter study in 20 US and
European centers. n engl j med 360;3 january 15, 2009
Slide 16
Angiography-guided PCI FFR-guided PCI Stent all indicated
stenoses Stent only those stenoses with FFR 0.80 Randomization
Indicate all lesions 50% amenable for stenting Patient with lesions
50% in at least 2 of the 3 major epicardial vessels 1-year
follow-up FAME Study Design Exclusion criteria: LM disease,
Previous CABG MI < 5 days Pregnancy, Life expectancy < 2
years n engl j med 360;3 january 15, 2009 496 pts509 pts
Slide 17
ANGIO- group N=496 FFR-group N=509P-value Indicated lesions per
patient 2.7 0.92.8 1.00.34 FFR results Lesions succesfully
measured, No (%) -1329 (98%)- Lesions with FFR 0.80, No (%) -874
(63%)- Lesions with FFR > 0.80, No (%) -513 (37%)- Stents per
patient 2.7 1.21.9 1.3
Flow Chart Stable CAD patients scheduled for 1, 2 or 3 vessel
DES-PCI N = 1220 FFR in all target lesions When all FFR > 0.80
(n=332) MT At least 1 stenosis with FFR 0.80 (n=888) Randomization
1:1 PCI + MT MT Follow-up after 1, 6 months, 1, 2, 3, 4, and 5
years Registry 50% randomly assigned to FU 27% FAME 2 : FFR-Guided
PCI versus Medical Therapy in Stable CAD Randomized Trial 73%
Slide 24
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD
Primary Outcomes 0 5 10 15 20 25 30 Cumulative incidence (%)
16615614513311710693746452412513Registry
4474143883513082772432121751551179253PCI+MT
4414143703222832532201921621271007037MT No. at risk
0123456789101112 Months after randomization MT vs. Registry: HR
4.32 (1.75-10.7); p
In 24 pts (44%), FFR was > 0.75 and medical treatment was
chosen & in 30 pts (56%), FFR was < 0.75 and bypass surgery
was performed. Survival among pts at 3 yrs of follow up was 100% in
medical group and 97% in surgical gp. Event-free survival was 76%
in medical gp and 83% in surgical gp. Heart 2001; 86:547552G J W
Bech, H Droste, N H J Pijls et al
Slide 33
Long-Term Outcome After FFR Guided Treatment in Patients With
Angiographically Equivocal LMCA Stenosis 213 pts with an
angiographically equivocal LMCA stenosis, FFR measurements were
performed. If FFR was 0.80, patients were treated medically or
another stenosis was treated by coronary angioplasty ( n 138). When
FFR was < 0.80, CABG was performed (n 75). 5-year survival
estimates were 89.8% in nonsurgical gp and 85.4% in surgical gp (P
= 0.48). The 5-year event-free survival estimates were 74.2% and
82.8% in the nonsurgical and surgical groups, respectively (P =
0.50) Circulation. 2009;120:1505-1512, Michalis Hamilos, Olivier
Muller et al
Slide 34
FFR for assessment of Nonculprit coronary artery stenoses in
patients with Acute MI. Aim : To investigate reliability of FFR of
nonculprit coronary stenoses during PCI in acute MI. 101 pts
undergoing PCI for acute MI were prospectively recruited. The FFR
measurements in 112 nonculprit stenoses were obtained immediately
after PCI of the culprit stenosis and were repeated 35 4 days
later. The FFR value of nonculprit stenoses did not change between
the acute and follow-up (0.77 0.13 vs 0.77 0.13, respectively, p
NS). JACC : V O L. 3, N O. 1 2, 2 0 1 0Argyrios Ntalianis,
Jan-Willem Sels et al
Slide 35
Physiological evaluation of provisional side-branch
intervention for bifurcation lesions using FFR Aim : To evaluate
functional outcomes of FFR -guided jailed sidebranch (SB)
intervention strategy. 110 pts were consecutively enrolled and SB
FFR was measured in 91 pts. SB intervention was allowed when FFR
was < 0.75. FFR measurement was repeated after SB intervention
and at 6- month follow-up angiography European Heart Journal (2008)
29, 726732 Koo, Park et al
Slide 36
In 26 of 28 SB lesions with FFR < 0.75, balloon angioplasty
was performed and FFR 0.75 was achieved in 92% of the lesions.
During follow-up, there were no changes in SB FFR in lesions with
(0.86 0.05 to 0.84 0.01, P = 0.4) and without SB angioplasty
(0.870.06 to 0.89 0.07, P = 0.1). Functional restenosis (FFR,0.75)
rate was only 8% (5/65). European Heart Journal (2008) 29, 726732
Koo, Park et al
Slide 37
Clinical outcomes of were compared with 110 pts with similar
bifurcation lesions treated without FFR-guidance, there was no
difference in 9-month cardiac event rates (4.6 vs. 3.7%, P = 0.7)
between two gps. Cardiac events were defined as cardiac death,
myocardial infarction, or target vessel revascularization European
Heart Journal (2008) 29, 726732 Koo, Park et al
Slide 38
Summary FFR is useful to assess angiographic intermediate
coronary lesions and can guide revascularization decisions in pts
with stable IHD. Medical therapy is appropriate when FFR 0.8.
Revascularization is recommended in lesions where FFR < 0.8 and
patient having evidence for ischemia. FFR is helpful in making
decision in intermediate LMCA disease. FFR can assess nonculprit
lesions during ACS. FFR is useful in intervention of bifurcation
lesions.
