1. Nico H.J. Pijls, William F. Fearon, Peter Jüni, and Bernard De Bruyne
FAME I and FAME II: Predictive Value of Fractional Flow Reserve After Drug-Eluting Stent Implantation
Zsolt Piróth
on behalf of
Gabor G. Toth, Pim A.L. Tonino, Emanuele Barbato, Nick Curzen, Gilles Rioufol,
Nico H.J. Pijls, William F. Fearon, Peter Jüni, and Bernard De Bruyne

2. Disclosure Statement of Financial Interest
I, [Zsolt Piróth], DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation

3. 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: ,
2 Barbato et al J Am Coll Cardiol 2016, in press

4. Objective
To investigate the potential of FFR measured immediately after DES implantation to predict clinical outcome in patients enrolled in the FAME 1 and FAME 2 studies.

5. 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 Composite End-point 2 years
Vessel-related CV death
Vessel-related spontaneous (non-periprocedural) MI
Ischemia-driven TVR (urgent & non-urgent)

6. Patients
Total FAME1 FAME p
Patients out of the study; n (%) 644 (67) 354 (70) 290 (65)
Age; years ± SD ± ± ±
BMI; kg/m2 ± SD ± ± ±
Male gender; n (%) (79) 283 (80) 228 (79)
Hypertension; n (%) (68) 212 (78) 227 (60) <0.001
Dyslipidemia; n (%) (74) 256 (72) 221 (76)
Diabetes mellitus; n (%) (25) (23) (28)
Smoker; n (%) (24) (27) (20)
Family history; n (%) (42) 135 (38) 138 (48)
Previous PCI; n (%) (23) (26) (20)
Previous MI; n (%) (38) 129 (36) 123 (39)
CCS <0.001
(22) (26) (17)
(39) 117 (33) 135 (47)
(23) (27) (18)
(11) (14) (8)

7. Vessels and procedures
Total FAME 1 FAME p
n=850 n=510 n=340
Target vessel; n (%)
LAD (52) (45) 208 (61)
Cx (22) (25) (19)
RCA (26) (30) (20) <0.001
Baseline diameter stenosis; n (%)
<50% (3) (4) (1)
50-70% 289 (34) (34) 114 (34)
71-90% 401 (47) (43) 183 (54)
90%< 131 (15) (18) (12) <0.001
Serial stenoses; n (%) 225 (26) (38) (9) <0.001
Baseline FFR; mean ± SD 0.63 ± ± ± 0.12 <0.001
Number of stents ± ± ±
Total stent length (mm) 25 ± ± ± 12 <0.001
Post-PCI FFR ± ± ±

8. Distribution of post-PCI FFR values
Low: <0,88, Middle: 0,88-0,92, High: >0,92

9. Rate of VOCE @ 2 years & Post-PCI FFR

10. 2-year outcome (@vessel-level)
TVR-free and VOCE-free is almost identical. Be prepared to answer this question !

11. Potential cut-off value
Post-PCI FFR value of 0.92 = “best cut-off”
Sensitivity %
Specificity %
Positive Likelihood ratio 1.31
Negative Likelihood ratio 0.58

12. 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

13. 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-point or as a target value to optimize PCI results