Registre Français FFR : R3F

Comité de pilotage : Patrick Dupouy (Antony), Eric Van Belle (Lille), Gilles Rioufol (Lyon), Christophe Pouillot

(St Denis la Réunion), Thomas Cuisset (Marseille)

But du Registre

– L’objectif de ce registre est d’évaluer l’utilisation du guide pression coronaire en France et la pratique de la technique de mesure FFR

– Base à une discussion de reconnaissance de l’acte par les tutelles.

Description • Registre français, prospectif, multicentrique• Inclusions 2008-2010• 1101 Patients• Suivi PH, 6 mois et 1 an• CRF Electronique (Clinigrid)• Sponsors

– St Jude-Radi– Biotronik

Critères d’évaluation Critère d’évaluation primaire :

– étude de la répartition des indications d’utilisation de la FFR– adéquation de la mesure FFR avec les décisions thérapeutiques– Impact de la FFR sur la décision thérapeutique– suivi clinique des MACE (évènement cardiaque majeur) jusqu’à 12 mois

et relation avec la valeur initiale de FFR. • Critères d’évaluation secondaires :

– appréciation de la valeur seuil utilisée – évaluation des coûts– pertinence de la mesure FFR dans l’ensemble des explorations

fonctionnelles pratiquées

Indications d’utilisation

3,9%

14%

5%

Baseline characteristics (n=945)

Stable 80%

- Angina 23%

- Atypical chest pain 11%

- No pain: 46%

Unstable 20% -Recent-STEMI 3%

-Recent-NON-STEMI 17%

Baseline characteristics (n=945)

Non invasive test performed 61%

- Positive 48% - Dubious 9% - Negative 4% Non-invasive test not performed

39%

Number of diseased vessels (>50%) - None 13% - 1 36% - 2 28% - 3 18% - Left main 5%Left ventricular EF, % - < 30% 4% - 30-50% 19% - > 50% 77%

Baseline characteristics (n=945)

Number of investigated lesions 1266 (1.3 0.4)

Index lesion (%)LADRCARCxLMLesion characteristics (%)A/B1B2/C

768 (61%)247 (20%)167 (13%)83 (7%)

830 (66%)436 (34%)

Reference diameter ± SD (mm) MLD ± SD (mm)% stenosis ± SD Lesion length ± SD (mm)

2.85 ±0.591.36 ±0.5952±1312.6 ±7.8

Baseline characteristics (n=945)

ApproachRadialFemoral

Size of catheter4F5F

67%37%

1%47%

6F 7F

Type of catheterDiagnosticIntervention

51%1%

45%55%

Baseline characteristics (n=945)

Adenosine : Mode of injectionICIV

99%1%

Adenosine : dose< 100µg100µg-200µg> 200µg

7%45%41%

FFRMeanFFR <0.8FFR <0.75

Threshold used0.800.75

0.82±.0941%25%

84%16%

Baseline characteristics (n=945)

Résumé

• 1101 Patients inclus• Base clôturée et figée• Adjudication des évènements terminée

Résultats R3F PCR 2012

Methods• To investigate this issue the investigators were asked

to define prospectively their revascularization strategy before performing the FFR (“A priori” strategy).

• This was compared to the final strategy applied to the patient after performing the FFR.

• Multivariable models were constructed in order to describe the revascularization decision process.

• The results of the first 945 consecutive patients are presented.

P=0.02

P=0.0001

Change of strategy in 47% of individuals

19

2157

3352

1637

11

0%

20%

40%

60%

80%

100%

A priori Final

Modified

CABG

PCI

Conservative

Change of Revascularization strategy according to the « a priori » strategy

group

« A priori » strategyn=491 n=350 n=104

Final strategy

64

4

10 832

6450

2642

0%

20%

40%

60%

80%

100%

Conserv. PCI CABG

CABG

PCI

Conservative

N= +181 N= -174 N= -65 N= -58

Multivariate analysis Encoding

• Conservative = 0• PCI= 1• CABG = 2

• Change in Revascularization strategy was encoded as the difference between the final strategy minus the « a priori » strategy.

Upgrade/Dowgrade Revascularization strategy:

A multivariate model (FFR not included)T β 95% CI β P

UpgradeNumb of diseased vessels

2.77 0.93 0.27-1.60 0.005

Length 2.61 0.12 0.03-0.2 0.009% stenosis 2.40 0.13 0.02-0.24 0.01Proximal lesion 2.03 1.37 0.05-2.70 0.04

DowngradeDiabetes Mellitus -2.62 - 1.76 -3.07 - - 0.44 0.009Ejection fraction - 2.11 -3.63 - 7.01 - -0.25 0.03Other variables in the model: Center, age, gender, previous MACE, symptoms, stability, non-invasive testing, LAD location, Reference diameter, MLD, ACC/AHA class.

Other variables in the model: Center, Age, gender, previous MACE, symptoms, stability, non-invasive testing, Ejection fraction, Number of diseased vessels, LAD location, Reference diameter, MLD, % stenosis, ACC/AHA class.

Upgrade/Dowgrade Revascularization strategy:

A multivariate model (FFR included)T β 95% CI β P

UpgradeProximal lesion 2.01 1.25 0.05-2.70 0.04

DowngradeFFR -

10.61- 38.18 - 45.25 - -

31.120.0001

Diabetes Mellitus -2.77 - 1.72 -2.94 - - 0.50 0.005

Conclusions• The present report, based on a large French

multicenter registry, demonstrates that although FFR had little impact on the overall rate of revascularization in patients referred for coronary angiography, it modifies the individual decision in about 1 out of 2 patients.

• This set of data provides additional support to the concept of "FFR guided revascularization" as an important tool to tailor the revascularization strategy in patients with CAD.