journal : evidence review pci : role of ffr

Journal : Evidence Review

PCI : Role of FFR

Dr Binjo J VazhappillySR 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 AccuracyPijls et al 60 X-ECG 0.74 97DeBruyne et al. 60 X-ECG/SPECT 0.72 85Pijls et al 45 X-ECG/SPECT/DSE 0.75 93Bartunek et al 37 DSE 0.68 90Abe et al 46 SPECT 0.75 91Chamuleau et al 127 SPECT 0.74 77Caymaz et al. 40 SPECT 0.76 95Jimenez-Navarro et al 21 DSE 0.75 90Usui et al 167 SPECT 0.75 79Yanagisawa et al 167 SPECT 0.75 76Meuwissen et al 151 SPECT 0.74 85DeBruyne et al 57 MIBI-SPECT post-MI 0.78 85Samady et al 48 MIBI-SPECT post-MI 0.78 85

JACC Vol. 55, No. 3, 2010

• 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;103:2928-2934G. Jan Willem Bech, MD; Bernard De Bruyne, MD, PhD; Nico H.J. Pijls MD et al

DEFER Group REFERENCE Group PERFORM Group

DEFER Study: Flow ChartPatients 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

Event Free survival : 2Yrs

Circulation 2001;103

Free from angina

Circulation 2001;103

No. at riskDefer group 90 85 82 74 73 72Perform group 88 78 73 70 67 65

Reference gr 135 105 103 96 90 88

78.872.764.4

0 1 2 3 4 50

25

50

75

100

Defer

Perform

Reference(FFR < 0.75)

p=0.52

p=0.17p=0.03

Years of Follow-up

Event free survival (%) : 5 Yrs

JACC Vol. 49, No. 21, 2007

0%

20%

40%

60%

80%

100%

baseline 1month 1 year 2 year 5 year

Defer group Perform group Reference group

Freedom from chest pain

FFR > 0.75 FFR > 0.75 FFR < 0.75

* ** *

* **

***

JACC Vol. 49, No. 21, 2007

*p 0.028

**p <0.001

***p 0.021

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

Angiography-guided PCI FFR-guided PCI

Stent all indicated stenosesStent 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 CABGMI < 5 daysPregnancy, Life expectancy < 2 years

n engl j med 360;3 january 15, 2009

496 pts 509 pts

ANGIO-groupN=496

FFR-groupN=509 P-value

Indicated lesions per patient 2.7 ± 0.9 2.8 ± 1.0 0.34

FFR resultsLesions 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 ± 1.2 1.9 ± 1.3 <0.001

Lesions succesfully stented (%) 92% 94% -

DES, total, No 1359 980 -

FAME study: Procedural Results

ANGIO-groupN=496

FFR-groupN=509 P-value

Events at 1 year, No (%)Death, MI, CABG or repeat-PCI 91 (18.4) 67 (13.2) 0.02Death 15 (3.0) 9 (1.8) 0.19Death or myocardial infarction 55 (11.1) 37 (7.3) 0.04CABG or repeat PCI 47 (9.5) 33 (6.5) 0.08

Total no. of MACE 113 76 0.02

Myocardial infarction, specifiedAll myocardial infarctions 43 (8.7) 29 (5.7) 0.07

FAME study: Adverse Events at 1 year

FFR-guided

30 days2.9% 90 days

3.8% 180 days4.9% 360 days

5.3%

Angio-guided

absolute difference in MACE-free survival

FAME study: Event-free Survival

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.

Flow ChartStable 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 stenosiswith 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 FU27%

FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD

Randomized Trial

73%


Primary Outcomes

0

5

10

15

20

25

30

Cum

ulat

ive

inci

denc

e (%

)

166 156 145 133 117 106 93 74 64 52 41 25 13Registry447 414 388 351 308 277 243 212 175 155 117 92 53PCI+MT441 414 370 322 283 253 220 192 162 127 100 70 37MT

No. at risk

0 1 2 3 4 5 6 7 8 9 10 11 12Months after randomization

MT vs. Registry: HR 4.32 (1.75-10.7); p<0.001

PCI+MT vs. Registry: HR 1.29 (0.49-3.39); p=0.61

PCI+MT vs. MT: HR 0.32 (0.19-0.53); p<0.001


Death from any Cause

0

5

10

15

20

25

30

Cum

ulat

ive

inci

denc

e (%

)


No. at risk0 1 2 3 4 5 6 7 8 9 10 11 12

Months after randomization

MT vs. Registry: HR 2.66 (0.14-51.18); p=0.30


PCI+MT vs. MT: HR 0.33 (0.03-3.17); p=0.31


Myocardial Infarction

0

5

10

15

20

25

30

Cum

ulat

ive

inci

denc

e (%

)


No. at risk




PCI+MT vs. MT: HR 1.05 (0.51-2.19); p=0.89


Urgent Revascularization

0

5

10

15

20

25

30

Cum

ulat

ive

inci

denc

e (%

)


No. at risk




PCI+MT vs. MT: HR 0.13 (0.06-0.30); p<0.001


Patients with urgent revascularization

Myocardial Infarction

Unstable angina+evidence of

ischemia on ECG

51.8%26.8%

21.4%

0 20 40 60 80Percentage of patients with CCS II to IV, %

Baseline

30 days

6 months

12 months

PCI+MTMT

Registry

PCI+MTMT

Registry

PCI+MTMT

Registry

PCI+MTMT

Registry


Patients with Angina Class II to IV

P<0.001

P=0.002

P=0.073

P=0.002

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 6-month 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).


• 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


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 .

journal : evidence review pci : role of ffr

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