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 3 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 4
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