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 14% 3,9% 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% Idm récent n=53 (20%)

Baseline characteristics (n=945) Non invasive test performed 61% - Positive 48% - Dubious 9% - Negative 4% Non-invasive test not performed 39% Idm récent n=53 (20%)

Baseline characteristics (n=945) 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 (%) LAD RCA RCx LM Lesion characteristics (%) A/B1 B2/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 ±0.59 1.36 ±0.59 52±13 12.6 ±7.8

Baseline characteristics (n=945) Approach Radial Femoral Size of catheter 4F 5F 67% 37% 1% 47% 6F 7F Type of catheter Diagnostic Intervention 51% 45% 55%

Baseline characteristics (n=945) Adenosine : Mode of injection IC IV 99% 1% Adenosine : dose < 100µg 100µg-200µg > 200µg 7% 45% 41% FFR Mean FFR <0.8 FFR <0.75 Threshold used 0.80 0.75 0.82±.09 25% 84% 16%

Résultats R3F PCR 2012 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. Obtenir des détails sur la méthode de dosage de l’insuline Regarder le nb de pts traités par insuline (in hospital)

P=0.02 DC ou DC+MI

Change of strategy in 47% of individuals 100% 7 11 5 P=0.0001 80% 21 Modified 37 60% CABG 16 PCI 19 40% Conservative DC ou DC+MI 52 20% 33 0% A priori Final

Change of Revascularization strategy according to the « a priori » strategy group 100% 10 8 32 Final strategy 80% 26 42 4 CABG 60% PCI 40% 64 64 Conservative DC ou DC+MI 50 20% 0% Conserv. PCI CABG n=491 n=350 n=104 « A priori » strategy

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) β 95% CI β P Upgrade Numb 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 0.01 Proximal lesion 2.03 1.37 0.05-2.70 0.04 Downgrade Diabetes Mellitus -2.62 - 1.76 -3.07 - - 0.44 Ejection fraction - 2.11 -3.63 - 7.01 - -0.25 0.03 plasma aldosterone [HR (log) = 3.48; p=0.004], hsCRP [HR (log) = 2.59; p=0.002], recent acute coronary syndrome [HR = 3.23, p=0.02], age [HR for a 10 year-increase = 1.42; p=0.04], diabetes [HR = 2.20; p=0.04] and LVEF [HR for a 10%-decrease = 1.58; p=0.001]. Other variables in the model: Center, age, gender, previous MACE, symptoms, stability, non-invasive testing, LAD location, Reference diameter, MLD, ACC/AHA class.

Upgrade/Dowgrade Revascularization strategy: A multivariate model (FFR included) β 95% CI β P Upgrade Proximal lesion 2.01 1.25 0.05-2.70 0.04 Downgrade FFR - 10.61 - 38.18 - 45.25 - -31.12 0.0001 Diabetes Mellitus -2.77 - 1.72 -2.94 - - 0.50 0.005 plasma aldosterone [HR (log) = 3.48; p=0.004], hsCRP [HR (log) = 2.59; p=0.002], recent acute coronary syndrome [HR = 3.23, p=0.02], age [HR for a 10 year-increase = 1.42; p=0.04], diabetes [HR = 2.20; p=0.04] and LVEF [HR for a 10%-decrease = 1.58; p=0.001]. 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.

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.