Transcript Journal Review FFR in PCI

Journal : Evidence Review
PCI : Role of FFR
Dr Binjo J Vazhappilly
SR Cardiology
MCH Calicut
• 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.
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
45
X-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
JACC Vol. 55, No. 3, 2010
85
• 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.
FFR in SCAD : 2013 ESC guidelines
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
DEFER Study: Flow Chart
Patients scheduled for PCI without
Proof of Ischemia (n=325)
Randomization
Performance of PTCA
(158)
Deferral of PTCA
(167)
FFR  0.75
(91)
No PTCA
DEFER Group
FFR < 0.75
(76)
PTCA
FFR < 0.75
(68)
PTCA
REFERENCE Group
FFR  0.75
(90)
PTCA
PERFORM Group
Event Free survival : 2Yrs
Circulation 2001;103
Free from angina
Circulation 2001;103
Event free survival (%) : 5 Yrs
100
75
78.8
72.7
64.4
Defer
50
p=0.52
p=0.03
Perform
25
p=0.17
Reference
(FFR < 0.75)
0
0
1
2
3
Years of Follow-up
4
5
No. at risk
Defer group
90
85
82
74
73
72
Perform group
88
78
73
70
67
65
Reference gr
135
105
103
96
90
88
JACC Vol. 49, No. 21, 2007
100%
80%
Freedom from chest pain
*p 0.028
**
**
**p <0.001
**
***p 0.021
*
***
60%
40%
20%
0%
baseline
Defer group
FFR > 0.75
1month
1 year
Perform group
FFR > 0.75
2 year
5 year
Reference group
FFR < 0.75
JACC Vol. 49, No. 21, 2007
Cumulative Events After 5 Yrs
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.
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
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
FAME Study Design
Patient with lesions ≥ 50% in at least 2
of the 3 major epicardial vessels
Indicate all lesions ≥ 50%
amenable for stenting
Randomization
Angiography-guided PCI
FFR-guided PCI
496 pts
509 pts
Stent only those stenoses with
FFR ≤ 0.80
Stent all indicated stenoses
1-year follow-up
Exclusion criteria:
LM disease, Previous CABG
MI < 5 days
Pregnancy, Life expectancy < 2 years
n engl j med 360;3 january 15, 2009
FAME study: Procedural Results
ANGIOgroup
N=496
FFR-group
N=509
P-value
2.7 ± 0.9
2.8 ± 1.0
0.34
-
1329 (98%)
-
Lesions with FFR ≤ 0.80 ,No (%)
-
874 (63%)
-
Lesions with FFR > 0.80 ,No (%)
-
513 (37%)
-
2.7 ± 1.2
1.9 ± 1.3
<0.001
Lesions succesfully stented (%)
92%
94%
-
DES, total,
1359
980
-
Indicated lesions per patient
FFR results
Lesions succesfully measured, No
(%)
Stents per patient
No
FAME study: Adverse Events at 1 year
ANGIOgroup
N=496
FFR-group
N=509
P-value
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
113
76
0.02
43 (8.7)
29 (5.7)
0.07
Events at 1 year, No (%)
Total no. of MACE
Myocardial infarction, specified
All myocardial infarctions
FAME study: Event-free Survival
absolute difference in MACE-free survival
FFR-guided
30 days
2.9%
Angio-guided
90 days
3.8%
180 days
4.9%
360 days
5.3%
End points at 2 years
JACC :Vol. 56, No. 3, 2010
FAME 2
• Aim: To compare clinical outcomes of FFR- guided contemporary
PCI plus best available medical therapy (MT) versus MT alone in
patients with stable CAD.
• Primary end points : Composite of all cause death ,MI, unplanned
hospitalization with urgent revascularization.
• The trial was conducted at 28 sites in Europe and North America.
• Patient recruitment was stopped on January 15, 2012, owing to a
highly significant difference in incidence rates of primary end point
between the PCI and medical- therapy groups.
•
Between May 15, 2010 and January 15, 2012, a total of 1220
patients were enrolled in the study.
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD
Flow Chart
Stable CAD patients scheduled for 1, 2 or 3 vessel DES-PCI
N = 1220
FFR in all target lesions
Registry
Randomized Trial
At least 1 stenosis
with FFR ≤ 0.80 (n=888)
When all FFR > 0.80
(n=332)
Randomization 1:1
PCI + MT
MT
73%
MT
27%
Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years
50% randomly
assigned to FU
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD
Cumulative incidence (%)
Primary Outcomes
30
PCI+MT vs. MT:
HR 0.32 (0.19-0.53); p<0.001
25
PCI+MT vs. Registry:
HR 1.29 (0.49-3.39); p=0.61
20
MT vs. Registry:
HR 4.32 (1.75-10.7); p<0.001
15
10
5
0
0
1
2
3
4
5
6
7
8
9
10
11
12
127
155
52
100
117
41
70
92
25
37
53
13
Months after randomization
No. at risk
MT
PCI+MT
Registry
441
447
166
414
414
156
370
388
145
322
351
133
283
308
117
253
277
106
220
243
93
192
212
74
162
175
64
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD
Cumulative incidence (%)
Death from any Cause
30
PCI+MT vs. MT:
HR 0.33 (0.03-3.17); p=0.31
25
PCI+MT vs. Registry:
HR 1.12 (0.05-27.33); p=0.54
MT vs. Registry:
HR 2.66 (0.14-51.18); p=0.30
20
15
10
5
0
0
No. at risk
MT
PCI+MT
Registry
1
2
3
4
5
6
7
8
9
10
11
12
154
163
55
122
122
43
90
95
27
54
54
13
Months after randomization
441
447
166
423
423
156
390
396
145
350
359
134
312
318
118
281
288
107
247
250
96
219
220
76
188
183
67
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD
Myocardial Infarction
Cumulative incidence (%)
30 PCI+MT vs. MT:
HR 1.05 (0.51-2.19); p=0.89
PCI+MT vs. Registry: HR 1.61 (0.48-5.37); p=0.41
25
MT vs. Registry:
HR 1.65 (0.50-5.47); p=0.41
0
3
20
15
10
5
0
1
2
4
5
6
7
8
9
10
11
12
148
157
53
117
119
42
85
94
26
48
54
13
Months after randomization
No. at risk
MT
PCI+MT
Registry
441
447
166
421
414
156
386
388
145
341
352
134
304
309
118
273
278
107
239
244
95
212
214
75
182
177
65
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD
Urgent Revascularization
Cumulative incidence (%)
30 PCI+MT vs. MT:
HR 0.13 (0.06-0.30); p<0.001
PCI+MT vs. Registry: HR 0.63 (0.19-2.03); p=0.43
25
MT vs. Registry:
HR 4.65 (1.72-12.62); p=0.009
0
3
20
15
10
5
0
1
2
4
5
6
7
8
9
10
11
12
129
160
53
101
119
42
71
93
26
38
53
13
Months after randomization
No. at risk
MT
PCI+MT
Registry
441
447
166
414
421
156
371
395
145
325
356
133
286
315
117
256
285
106
223
248
94
195
217
75
164
180
65
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD
Patients with urgent revascularization
21.4%
Myocardial
Infarction
51.8%
26.8%
Unstable angina
+evidence of
ischemia on ECG
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD
Patients with Angina Class II to IV
Baseline
PCI+MT
MT
Registry
30 days
PCI+MT
MT
Registry
6 months
PCI+MT
MT
Registry
12 months
P<0.001
P=0.002
P=0.002
PCI+MT
MT
Registry
P=0.073
0
20
40
60
Percentage of patients with CCS II to IV, %
80
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD
Conclusions
• In patients with stable coronary artery disease, FFR-guided PCI,
improve patient outcome as compared with medical therapy alone.
• This improvement is driven by a dramatic decrease in the need for
urgent revascularization for ACS.
• In patients with functionally non-significant stenoses medical therapy
alone resulted in an excellent outcome, regardless of the angiographic
appearance of the stenoses.
Value of FFR in making decisions about bypass
surgery for equivocal LMCA disease .
• Was a 2 centre prospective , single cohort follow up study.
• FFR of LMCA was determined in 54 consecutive pts with
angiographically equivocal disease.
• If FFR was > 0.75, medical treatment was chosen and if FFR was
< 0.75, surgical treatment was chosen.
Heart 2001; 86:547–552
G J W Bech, H Droste, N H J Pijls et al
• 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; 86:547–552
G J W Bech, H Droste, N H J Pijls et al
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
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 0
Argyrios Ntalianis, Jan-Willem Sels et al
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 6month follow-up angiography
European Heart Journal (2008) 29, 726–732 Koo , Park et al
• 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
(0.87±0.06 to 0.89 ± 0.07, P = 0.1).
• Functional restenosis (FFR ,0.75) rate was only 8% (5/65).
European Heart Journal (2008) 29, 726–732 Koo , Park et al
• 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, 726–732 Koo , Park et al
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 .