Routine FFR measurement after PCI: two-year follow-up of ...
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Routine fractional flow reserve measurement after PCI the FFR-search study 2-year follow-up
Roberto Diletti MD, PhD,On behalf of the Thoraxcenter Investigators:
K. Masdjedi; L. van Zandvoort; Miguel Lemmert; Rutger van Bommel; W. den Dekker; J. Wilschut; P. de Jaegere; E. Boersma; F. Zijlstra;
J. Daemen; N. Van Mieghem
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Disclosure
☑ Institutional research grants from ACIST Medical Systems
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Fractional flow reserve (FFR) is a reliable index of the physiological significance of coronary stenosis
FFR-guided treatment improves percutaneous coronary intervention (PCI) related outcomes
However the impact of FFR values after PCI on clinical outcomes is unclear
Background
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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
Guide-wire access to the vessel was maintained and a novel monorail micro-catheter with optical pressure FFR sensor technology was inserted
Methods
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Methods
The primary endpoint of our study was MACE defined as the composite of Cardiac death, Any non fatal MI, Any revascularization at 2-year follow-up.
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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 flowchart
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Number of lesions per 0.01 FFR increment
Per-vessel analysis
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Patient data:
959 patients with 1165 vessels assessed (1.2 vessels per patient)
• 560 patients (58%) with all vessels ≥0.90
• 399 patients (42%) with ≥1 vessels <0.90
• 213 patients (22%) with ≥1 vessels ≤0.85
• 85 patients (8.9%) with ≥1 vessels ≤0.80
Per-patient analysis
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2-year Clinical outcomes
FFR < 0.90(N=399)
FFR ≥ 0.90(N=560)
P- value
MACE 13.7% 11.8% 0.40
All-cause mortality 7.4% 5.5% 0.24
Cardiac mortality 4.2% 2.7% 0.21
Myocardial infarction 5.6% 3.4% 0.09
Any revascularization 11.0% 9.0% 0.33
Stent thrombosis 2.4% 1.0% 0.09
MACE define as the composite of Cardiac death, Any non fatal MI, Any revascularizationPercentages are reported for patients with complete FU
959 patients with at least 1 FFR value
850 (89%) with complete 2-year follow-up
FFR ≤ 0.85(N=213)
FFR > 0.85(N=746)
P- value
Myocardial infarction 7.0% 3.5% 0.03
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2-year Clinical outcomes
Kaplan-Meier curves with FFR Threshold 0.90
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0 6 12 18 24
Time (months)
FFR < 0.90
FFR ≥ 0.901.0%
2.4%
10
8
4
2
0
Eve
nt
rate
(%
)
Stent thrombosis
P = 0.09
6
FFR <0.90 FFR ≥0.90
No. of stent thromboses 9 4 Acute (<24h) 0 0
Subacute (1-30 days) 3 1
Late (30-365 days) 4 1
Very late (>1 year) 2 2
2-year Clinical outcomes
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• Post PCI microcatheter-based FFR is feasible.
• A FFR value < 0.90 is common.
• A suboptimal post PCI FFR < 0.90 might be associated with more ST and MI at follow-up
• The randomized FFR REACT study evaluating FFR guided PCI optimization directed by high-definition IVUS versus Angio-guided PCI is currently on-going
Conclusions