Fraktional Flow Reserve guided revaskularisering ved

FFR guided revaskularisering ved CABG
Fractional Flow Reserve versus
Angiography Randomization for Graft
Optimization trial
FARGO
Multicenter studie som skal danne baggrund for et ph.d.-studie af
Anne Langhoff Thuesen, Hjertekirurgisk Afdeling T, OUH
12-03-2015
Baggrund
Årsager til graftokklusion efter
CABG?
Kan trykmåling før CABG optimere
revaskulariseringsplanen?
Forbedre graft holdbarhed?
Golden Standard i dag er stadig KAG guided CABG.
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Moderate stenoser
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Fractional Flow Reserve
FFR ≤ 0,8 = fysiologisk betydende stenose
Maksimal hyperæmi opnås ved Adenosin
indgift 140 ug/kg/min i.v. Indtil steady state
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
FFR-studier ved PCI (RCT)
FFR vs. KAG – guided Percutan Coronar Intervention (PCI)
DEFER 2007
• Man kan undlade
PCI på læsioner,
hvis FFR ≥ 0,75,
da PCI i disse
tilfælde ikke
gavner patienten.
FAME 2009
FAME 2
• FFR guided PCI
reducerer
forekomst af død,
MI og TVR sign.
efter 1-2 år.
• PCI er medicinsk
behandling
overlegen, hvis
læsionerne er
flowbegrænsende
(FFR < 0,8).
=> Moderate stenoser bør vurderes med FFR-måling før evt. PCI.
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
1
FFR guided revaskularisering ved CABG
FFR-studier ved CABG
12-03-2015
Clinical events in the angiography (Angio)-guided and fractional flow
reserve (FFR)–guided group during the 36-month follow-up.
Does Stenosis Severity of Native Vessels Influence Bypass Graft
Patency? A Prospective Fractional Flow Reserve–Guided Study
Cornelis J. Botman , Jacques Schonberger , Sjaak Koolen , Olaf Penn , Hilde Botman , Nabil Dib , Eric Eeckhout , ...
Fig 3 The relation between functional stenosis severity established by fractional flow reserve (FFR) measurements and graft failure at
angiographic follow-up after 1 year.
Toth G et al. Circulation. 2013;128:1405-1411
The Annals of Thoracic Surgery, Volume 83, Issue 6, 2007, 2093 - 2097
Fractional Flow Reserve–Guided Versus AngiographyGuided Coronary Artery Bypass Graft Surgery
Copyright © American Heart Association, Inc. All rights reserved.
ClinicalTrials.gov
Hypotese
Graft Patency After FFR-guided Versus
Angio-guided CABG (GRAFFITI) Trial.
A Prospective, Multicenter, Multinational,
Randomized (1:1) Controlled Trial.
Inclusion started 2013.
200 pt. 1 års follow-up.
PE: graft occlusion.
Bypass grafting af ikke flowbegrænsende
stenoser øger risikoen for graft failure.
A Comparison of Fractional Flow Reserve
Guided Percutaneous Coronary Intervention
and Coronary Artery Bypass Graft Surgery
in Patients With Multivessel Coronary Artery
Disease (FAME 3)
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Patients scheduled for CABG
Formål
Randomization
 Sammenligne FFR-guided vs. KAG-guided CABG på
graft patency.
FFR measurements of possible stenoses scheduled for grafting
FFR guided treatment
CAG guided treatment
6-month GRAFT FAILURE (%)
 Vurdere graft patency efter 6 måneder af grafter sat på
koronararterier, hvis stenoser henholdsvis var/ikke var
flow-begrænsende, målt ved FFR før CABG.
 Undersøge en evt. sammenhæng mellem graft
patency efter 6 måneder og symptomer på iskæmi.
Symptoms, quality of life, MACCE
FFR > 0.8
FFR ≤ 0.8
FFR ≤ 0.8
FFR > 0.8
- graft
+ graft
+ graft
+ graft
DEFER group
FFR 0-6 mdr.
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Patient level
REFERENCE group
Vessel/graft occlusion (%) 0-6 mdr.
Patient level endpoint
Lesion level
PERFORM group
Graft failure (%) 0-6 mdr
Lesion level endpoint
2
FFR guided revaskularisering ved CABG
Endepunkter
Primære endepunkt:
 Åbentstående grafter med TIMI 3 flow uden anastomosestenose
efter 6 mdr.
12-03-2015
Eksklusion
Inklusion
 Pt. visiteret til CABG med
 Kombinationsingreb
SAP/UAP/NSTEMI
 Tidl. Åben hjerteoperation
 Mindst én egnet studielæsion*
Sekundære endepunkter:
 Graftflowgraduering
 Ændring i CCS-klasse fra index – FU
 Ændring i Quality of Life fra index – FU
 MACCE ved FU.
 Procedurerelaterede max TnI, TnT eller CKMB værdier.
 Proceduretid (CABG).
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Patient inklusion og rekruttering
 Hovedstammestenose alene
 Signeret samtykke
 Persantin Retard – behandling
 Alder > 18 år
 Creatinin >150 umol/l
 1VD
*Studielæsion definition: En ≥ 50%
stenose på en stor epicardiel arterie
(prox. ref. segm. diam. >2,5 mm), som
kan passeres med en FFR-wire uden
betydende risiko. Studielæsioner kan
udvælges fra ALLE kranspulsårer.
 Akut operation
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Iskæmikonference
Der inkluderes patienter i studiet indtil der er randomiseret
168 studiekar med FFR > 0,8.
Beslutning om
CABG
Graftplan fra KAG
Hjertemedicinske og hjertekirurgiske afdelinger på:
Odense Universitetshospital
Egnede studiekar til
FFR-måling
Aarhus Universitetshospital
Aalborg Universitetshospital
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Operation
Inklusion og FFR-måling
Inklusion
CABG i henhold til
graftplan
Flow- og PI-måling i alle
grafter efter dekanylering
Single grafter til studiekar
Registrering af perfusionstid,
tangtid og OP-varighed
Randomisering
FFR-måling af
studiekar
Evt. justering af
graftplan
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Kvalitetsvurdering af
graftmateriale
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
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FFR guided revaskularisering ved CABG
12-03-2015
Vejledere
Follow-up 6 mdr.
 Ambulant KAG af grafter.
Lisette Okkels Jensen, overlæge, dr. med. ph.d., Hjertemedicinsk Afdeling B
(hovedvejleder)
Poul Erik Mortensen, overlæge, Hjertekirurgisk Afdeling T (vejleder)
Per Thayssen, overlæge dr. med., Hjertemedicinsk Afdeling B (vejleder)
Odense Universitetshospital
 Graduering af graftflow til studiekar.
 FFR-måling af kar i DEFER gruppen (kar med
Evald Høj Christiansen, overlæge ph.d., Hjertemedicinsk Afdeling, Skejby
(vejleder)
Aarhus Universitetshospital
FFR > 0,8, som blev randomiseret til ingen
graft).
Svend Eggert Jensen, overlæge ph.d., Kardiologisk Afdeling (vejleder)
Aalborg Universitetshospital
 Klinisk kontrol (CCS, QOL)
Studiet opstartet 01.06.2014
14 patienter inkluderet i Odense indtil nu.
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
Referencer
Spørgsmål
Fractional Flow Reserve versus Angiography for Graft Optimization
Trial - FAGOT
1.
Tonino PAL, Fearon WF. Fractional Flow Reserve versus Angiography for Guiding
Percutaneous Coronary Intervention. N Engl J Med 2009; 360: 213-24.
2.
Pijls NH, Bruyne B. Percutaneous coronary intervention of functionally
nonsignificant stenosis. 5-year follow-up of the DEFER study. J Am Coll Cardiol
2007; 49: 2105-11.
3.
Botman CJ, Pijls NH. Does stenosis severity of native vessels influence bypass
graft patency? A prospective fractional flow reserve-guided study. Ann Thorac
Surg 2007; 83: 2093-7.
4.
De Bruyne B, Fearon W. Fractional flow reserve-guided PCI versus medical
therapy in stable coronary disease. NEJM 2012; 367(11): 991-1001.
5.
Clinicaltrials.gov. Graft Patency After FFR-guided Versus Angio-guided CABG
(GRAFFITI) Trial. Principal Investigators: Emanuele Barbato, Bernard De Bruyne,
Gabor Toth.
Fractional Flow Reserve versus Angiography Randomization for
Graft Optimization trial - FARGO
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