PMID- 34310907 OWN - NLM STAT- MEDLINE DCOM- 20211021 LR - 20220323 IS - 1097-6744 (Electronic) IS - 0002-8703 (Linking) VI - 241 DP - 2021 Nov TI - The Full Revasc (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based randomized clinical trial. PG - 92-100 LID - S0002-8703(21)00186-1 [pii] LID - 10.1016/j.ahj.2021.07.007 [doi] AB - BACKGROUND: Complete revascularization in ST elevation myocardial infarction (STEMI) patients with multivessel disease has resulted in reduction in composite clinical endpoints in medium sized trials. Only one trial showed an effect on hard clinical endpoints, but the revascularization procedure was guided by angiographic evaluation of stenosis severity. Consequently, it is not clear how Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) affects hard clinical endpoints in STEMI. METHODS AND RESULTS: The Ffr-gUidance for compLete non-cuLprit REVASCularization (FULL REVASC) - is a pragmatic, multicenter, international, registry-based randomized clinical trial designed to evaluate whether a strategy of FFR-guided complete revascularization of non-culprit lesions, reduces the combined primary endpoint of total mortality, non-fatal MI and unplanned revascularization. 1,545 patients were randomized to receive FFR-guided PCI during the index hospitalization or initial conservative management of non-culprit lesions. We found that in angiographically severe non-culprit lesions of 90-99% severity, 1 in 5 of these lesions were re-classified as non-flow limiting by FFR. Considering lesions of intermediate severity (70%-89%), half were re-classified as non-flow limiting by FFR. The study is event driven for an estimated follow-up of at least 2.75 years to detect a 9.9%/year>7.425%/year difference (HR = 0.74 at 80% power (alpha = .05)) for the combined primary endpoint. CONCLUSION: This large randomized clinical trial is designed and powered to evaluate the effect of complete revascularization with FFR-guided PCI during index hospitalization on total mortality, non-fatal MI and unplanned revascularization following primary PCI in STEMI patients with multivessel disease. Enrollment completed in September 2019 and follow-up is ongoing. CI - Copyright (c) 2021. Published by Elsevier Inc. FAU - Bohm, Felix AU - Bohm F AD - Department of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden. Electronic address: felix.bohm@ki.se. FAU - Mogensen, Brynjolfur AU - Mogensen B AD - Department of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden. FAU - Ostlund, Ollie AU - Ostlund O AD - Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. FAU - Engstrom, Thomas AU - Engstrom T AD - Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. FAU - Fossum, Eigil AU - Fossum E AD - Department of Cardiology, Oslo University Hospital Ulleval, Oslo, Norway. FAU - Stankovic, Goran AU - Stankovic G AD - University Clinical Center of Serbia, University of Belgrade, Belgrade, Serbia. FAU - Angeras, Oskar AU - Angeras O AD - Department of Cardiology, Sahlgrenska University Hospital, Goteborg, Sweden. FAU - Erglis, Andrejs AU - Erglis A AD - Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia. FAU - Menon, Madhav AU - Menon M AD - Department of Cardiology, Waikato Hospital, Hamilton, New Zealand. FAU - Schultz, Carl AU - Schultz C AD - Medical School, University of Western Australia, Perth, Australia; Department of Cardiology, Royal Perth Hospital, Perth, Australia. FAU - Berry, Colin AU - Berry C AD - West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK. FAU - Liebetrau, Christoph AU - Liebetrau C AD - Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany; Department of Internal Medicine I, Division of Cardiology, University of Giessen, Giessen, Germany. FAU - Laine, Mika AU - Laine M AD - Department of Vascular Surgery, Abdominal Center, Helsinki University and Helsinki University Central Hospital, Helsinki, Finland. FAU - Held, Claes AU - Held C AD - Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden; Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden. FAU - Ruck, Andreas AU - Ruck A AD - Department of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden. FAU - James, Stefan K AU - James SK AD - Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden; Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden. LA - eng SI - ClinicalTrials.gov/NCT02862119 GR - MR/N003403/1/MRC_/Medical Research Council/United Kingdom GR - RE/18/6134217/BHF_/British Heart Foundation/United Kingdom PT - Journal Article PT - Multicenter Study PT - Pragmatic Clinical Trial PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20210724 PL - United States TA - Am Heart J JT - American heart journal JID - 0370465 SB - IM MH - Aged MH - Coronary Angiography/*methods MH - *Coronary Stenosis/diagnosis/physiopathology MH - Emergency Medical Services/methods/statistics & numerical data MH - Female MH - *Fractional Flow Reserve, Myocardial MH - Humans MH - Male MH - Middle Aged MH - Mortality MH - Outcome and Process Assessment, Health Care MH - Percutaneous Coronary Intervention/*methods/statistics & numerical data MH - Registries/statistics & numerical data MH - *ST Elevation Myocardial Infarction/diagnosis/mortality/physiopathology/surgery MH - Severity of Illness Index MH - Surgery, Computer-Assisted/methods/statistics & numerical data EDAT- 2021/07/27 06:00 MHDA- 2022/03/24 06:00 CRDT- 2021/07/26 20:09 PHST- 2021/07/19 00:00 [received] PHST- 2021/07/19 00:00 [accepted] PHST- 2021/07/27 06:00 [pubmed] PHST- 2022/03/24 06:00 [medline] PHST- 2021/07/26 20:09 [entrez] AID - S0002-8703(21)00186-1 [pii] AID - 10.1016/j.ahj.2021.07.007 [doi] PST - ppublish SO - Am Heart J. 2021 Nov;241:92-100. doi: 10.1016/j.ahj.2021.07.007. Epub 2021 Jul 24.