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

Disclosure

☑ Institutional research grants from ACIST Medical Systems

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

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

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.

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

Number of lesions per 0.01 FFR increment

Per-vessel analysis

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

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

2-year Clinical outcomes

Kaplan-Meier curves with FFR Threshold 0.90

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

• 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