This document summarizes a study investigating the ability of post-PCI FFR measurements to predict clinical outcomes. The study found: 1) Vessels with lower post-PCI FFR values (<0.92) were associated with higher rates of adverse cardiac events at 2 years compared to vessels with higher FFR values (>0.92). 2) However, post-PCI FFR had low sensitivity, specificity, and likelihood ratios for predicting individual patient outcomes. 3) Therefore, while lower post-PCI FFR was associated with worse population-level outcomes, it cannot be used to reliably predict or optimize outcomes for individual patients.

1. Post-PCI FFR:
Lessons from FAME
Zsolt Piróth MD FESC
Hungarian Institute of Cardiology
Budapest, Hungary
AIMRADIAL 2017
Stuttgart, Sept. 20, 2017

2. I have no conflict of interest to declare
DISCLOSURES

3. 1
Piroth Z, Toth GG, et al. Circ Cardiovascular Interv 2017

4. Introduction
 FFR has a IA indication to identify
hemodynamically significant lesions when
evidence of ischemia is not available1
 In medically treated patients, outcome data
indicate a risk continuum for FFR values, with
lower values having higher event rates2
1
Windecker et al Eur Heart J 2014;35:2541-2619,
2
Barbato et al J Am Coll Cardiol 2016, 68: 2247-55

5. Why is post-PCI FFR not 1.0?
 Diffuse coronary artery disease
 Other circumcript (unnoticed / neglected)
lesion in the index vessel
 Suboptimal stent placement
 Drift

6. Objective
To investigate the potential of FFR measured
immediately after DES implantation to predict
clinical outcome.

7. Methods
 Patients: all patients from FAME 1 and 2 who had
post-PCI FFR measurement
 Vessels: relationship between post-PCI FFR and
outcome is reported on a vessel level
 End-point: Vessel-Oriented Cardiac Event (VOCE)
@ 2 years
Vessel-related CV death
Vessel-related spontaneous (non-periprocedural) MI
Ischemia-driven TVR (urgent & non-urgent)

8. Patients
Total FAME1 FAME 2 p
•No. of pts out of the study; n (%) 644 (67) 354 (70) 290 (65) 0.307
•Age; years± SD 64±10 65±10 63±9 0.102
•BMI; kg/m2
± SD 28±5 27±6 28±4 0.458
•Male; n (%) 511 (79) 283 (80) 228 (79) 0.918
•Hypertension; n (%) 439 (68) 212 (78) 227 (60) <0.001
•Dyslipidaemia; n (%) 477 (74) 256 (72) 221 (76) 0.534
•Diabetes mellitus; n (%) 161 (25) 81 (23) 80 (28) 0.390
•Smoker; n (%) 153 (24) 95 (27) 58 (20) 0.128
•Positive family history; n (%) 273 (42) 135 (38) 138 (48) 0.054
•Previous PCI; n (%) 148 (23) 91 (26) 57 (20) 0.192
•Previous MI; n (%) 242 (38) 129 (36) 123 (39) 0.805
•CCS <0.001
1 141 (22) 92 (26) 49 (17)
2 252 (39) 117 (33) 135 (47)
3 145 (23) 94 (27) 51 (18)
4 74 (11) 51 (14) 32 (8)

9. Vessels and procedures
Total FAME 1 FAME 2 p
n=850 n=510 n=340
Target vessel; n (%)
LAD 439 (52) 231 (45) 208 (61)
Cx 191 (22) 126 (25) 65 (19)
RCA 220 (26) 153 (30) 67 (20) <0.001
Baseline diameter stenosis; n (%)
<50% 23 (3) 21 (4) 2 (1)
50-70% 289 (34) 175 (34) 114 (34)
71-90% 401 (47) 218 (43) 183 (54)
90%< 131 (15) 90 (18) 41 (12) <0.001
Serial stenoses; n (%) 225 (26) 195 (38) 30 (9) <0.001
Baseline FFR; mean ± SD 0.63 ± 0.14 0.61 ± 0.15 0.67 ± 0.12 <0.001
Number of stents 1.3 ± 0.6 1.3 ± 0.6 1.3 ± 0.6 0.509
Total stent length (mm) 25 ± 13 27 ± 14 23 ± 12 <0.001
Post-PCI FFR 0.90 ± 0.06 0.90 ± 0.07 0.90 ± 0.06 0.108

10. Distribution of post-PCI FFR values
Low: <0.88, Middle: 0.88-0.92, High: >0.92

11. Predictors of post-PCI FFR
 Lower post-PCI FFR:
 Male gender
 Diabetes mellitus
 LAD location
 Multiple stents in the index vessel
 Higher post-PCI FFR:
 Higher baseline % diameter stenosis
 Higher baseline FFR
By multiple regression analysis

12. Rate of VOCE @ 2-yrs & post-PCI FFR
RateofVOCE@2years
Post-PCI FFR

13. 2-year outcome (VOCE)

14. 2-year outcome (death)

15. 2-year outcome (MI)

16. 2-year outcome (TVR)

17. Potential cut-off value
Post-PCI FFR 0.92 = “best cut-off”
• Sensitivity 75%
• Specificity 43%
• Positive Likelihood ratio 1.31
• Negative Likelihood ratio 0.58

18. Conclusion
Vessels with a lower post-PCI FFR (DES) were
associated with more events than vessels with
higher post-PCI FFR values (cut-off value of 0.92)
This difference remained significant even after
adjustment for various clinical, angiographic and
procedural characteristics
This “residual FFR burden” further extends the
overall prognostic value of FFR to post-PCI
measurements (at a population level)

19. Conclusion II
However, the sensitivity (75%), specificity (43%),
and likelihood ratios (<1.5) to predict further
events were low
Therefore, post-PCI FFR cannot be proposed as a
surrogate for clinical end-points or as a target
value to optimize PCI results: it is too weak to
rule in or rule out future events in individual
patients

20. Thank
you!