Post-PCI FFR was measured in over 1000 patients using a novel microcatheter. Over 40% of lesions had an FFR ≤0.90 after stenting. Clinical outcomes at 30 days were low and similar across FFR groups. The results suggest post-PCI FFR assessment is safe and identifies opportunities for PCI optimization that may improve long-term outcomes, as will be studied in the upcoming FFR REACT trial.

1. Post-PCI FFR:
Rotterdam experience
Roberto Diletti MD, PhD,
Thoraxcenter Erasmus MC, Rotterdam The Netherlads
On behalf of the Thoraxcenter Investigators:
R. Van Bommel, K. Masdjedi; L. van Zandvoort; M. Lemmert; J. Wilschut; P. de Jaegere; E.
Boersma; F. Zijlstra; J. Daemen; N. Van Mieghem

2. Disclosure
I have no financial conflicts of interest related to
this presentation

3. Background
Fractional flow reserve (FFR) is a reliable index
of the physiological significance of coronary
stenosis and FFR-guided treatment improves
percutaneous coronary intervention (PCI)
related outcome.
However the impact of FFR values after PCI on
clinical outcomes is unclear.

4. Methods
• Prospective all comers registry.
• All patients who underwent successful PCI were
eligible.
• FFR measurements were performed after PCI when
the angiographic result was considered acceptable
by the operator.
• Wire access to the vessel was maintained and a
novel monorail optical pressure sensor FFR micro-
catheter was inserted over the previously used
coronary guide-wire

5. • Delivered over a standard 0.014” guidewire
• Marker band located 2.5mm from tip
• Fiber-optic sensor 2.5mm from marker band (5mm from tip)
• Profile comparable to 0.022” diameter at lesion site
Catheter-based FFR:
Navvus MicroCatheter

6. • Modestly lower FFR value compared with a traditional pressure wire, with an average bias of
-0.02
• Upon multivariate analysis, lower FFR as measured by the microcatheter is the only
predictor of a greater difference between the two measurements, independent of vessel
and lesion characteristics
MicroCatheter vs PWS
Matthew J. Price EuroPCR 2017

7. 1000 Navvus patients
959 patients with ≥1
measured lesion
- 28 “no-cross”
- 11 equipment failure
- 2 response to Adenosine
1348 lesions
1165 lesions measured
- 14 “no-cross”
- 9 patient unstable
- 22 operator decision
- 28 other reason
- 109 vessel too small
- 1 equipment failure
1512 patients with PCI - 156 unstable
- 148 operator decision
- 129 only vessel(s) too small
- 79 other reasons
FFR-SEARCH: inclusion flowchart

8. N=1000
Age (years) 64.6 ± 11.8
Male gender (n) 725 (72.5%)
Hypertension (n) 515 (51.5%)
Hypercholesterolemia (n) 451 (45.1%)
Diabetes (n) 191 (19.1%)
Smoking history (n) 499 (49.9%)
Prior stroke (n) 77 (7.7%)
Peripheral art. Disease (n) 76 (7.6%)
Prior myocardial infarction (n) 203 (20.3%)
Prior PCI (n) 264 (26.4%)
Prior CABG (n) 57 (5.7%)
Hb level (mmol/L) 8.7 ± 1.0
Creatinine (µmol/L) 92 ± 51
Indication for PCI (n)
Stable angina 304 (30.4%)
Unstable angina / NSTEMI 367 (36.7%)
Acute myocardial infarction 329 (32.9%)
No. of lesions treated 1.40 ± 0.6
No. of lesions measured 1.21 ± 0.5
Baseline characteristics

9. Overall results in 959 patients with 1165 lesions
N=1165
Average Pd/Pa 20mm distal of stent 0.96 ± 0.04
Average FFR value 20mm distal of stent 0.91 ± 0.07
Average FFR value distal stent edge 0.95 ± 0.06
Average FFR value proximal stent edge 0.98 ± 0.04
Average drift value 0.011 ± 0.015
Average time per lesion (minutes) 5.0 ± 1.4
“no-cross” in 42 out of 1207 attempted lesions 3.5%
Navvus related complications occurred 0
FFR procedural results

10. (N = 1165 lesions)
0.6 0.7 0.8 0.9 1.0 1.1
0
20
40
60
80
100
FFR value
No.oflesions
• 660 lesions (56.7%) >0.90
• 505 lesions (43.3%) ≤0.90
• 231 lesions (19.8%) ≤0.85
• 90 lesions (7.7%) ≤0.80
FFR-SEARCH:
Number of lesions per 0.01 FFR increment

11. • Patient data:
- 959 patients with 1165 measured lesions (1.2 lesions per
patients)
• 503 patients (52%) with all lesions >0.90
• 456 patients (48%) with ≥1 lesion ≤0.90
• 213 patients (22%) with ≥1 lesion ≤0.85
• 85 patients (8.9%) with ≥1 lesion ≤0.80
FFR-SEARCH:
FFR results per patient analysis

12. 897 patients with index procedure >30 days ago
798 (89%) with complete 30-days follow-up
N=798
MACE 15 (1.9%)
All-cause mortality 7 (0.9%)
Cardiac mortality 5 (0.6%)
Myocardial infarction 8 (0.8%)
TLR 3 (0.4%)
TVR 4 (0.5%)
Stent thrombosis 3 (0.4%)
Any revascularization 9 (1.1%)
Stroke 0
Bleeding 1 (0.1%)
30-day clinical outcomes

13. 0 10 20 30
90%
92%
94%
96%
98%
100%
FFR 80
FFR 81-85
FFR 86-90
FFR >90
P = 0.792
FFR ≤0.80
FFR 0.81-0.85
FFR 0.86-0.90
FFR >0.90
MACE defined as: all-cause mortality, MI, any revascularization
MACE at 30-day follow-up

14. FFR80
(N = 71)
FFR 81-85
(N = 117)
FFR 86-90
(N = 199)
FFR >90
(N = 411)
0%
1%
2%
3%
MACErate
2.8%
2.6%
2.0%
1.5%
MACE rate
per FFR subgroup
MACE defined as: all-cause mortality, MI, any revascularization

15. • Microcatheter based FFR post-PCI allows a safe
physiological assessment of the treatment result.
• A relevant percentage of the stented vessels has FFR <0.90.
• PCI optimization by microcatheter based FFR may improve
clinical outcome.
• FFR REACT is an upcoming randomized trial to study the
clinical impact of IVUS directed FFR optimization of PCI.
Conclusions