6533b836fe1ef96bd12a13a9

RESEARCH PRODUCT

The Full Revasc (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based randomized clinical trial

Stefan JamesOskar AngeråsAndreas RückCarl SchultzAndrejs ĒRglisMika LaineOllie ÖStlundMadhav MenonBrynjölfur MogensenChristoph LiebetrauThomas EngstrømFelix BöhmEigil FossumGoran StankovicClaes HeldColin Berry

subject

MaleEmergency Medical Servicesmedicine.medical_treatmentFractional flow reserve030204 cardiovascular system & hematologyCoronary AngiographyGUIDELINESSeverity of Illness IndexANGIOGRAPHYDISEASElaw.invention0302 clinical medicineRandomized controlled triallawFRACTIONAL FLOW RESERVEClinical endpointMedicineCardiac and Cardiovascular Systems030212 general & internal medicineRegistriesKardiologiMiddle Aged3. Good healthFractional Flow Reserve MyocardialOutcome and Process Assessment Health CareSurgery Computer-AssistedCardiologyFemaleCardiology and Cardiovascular Medicinemedicine.medical_specialtyRevascularizationCulpritLESION03 medical and health sciencesPercutaneous Coronary InterventionInternal medicineHumanscardiovascular diseasesMortalityANGIOPLASTYAgedbusiness.industryCoronary StenosisELEVATION MYOCARDIAL-INFARCTIONPercutaneous coronary interventionmedicine.disease3126 Surgery anesthesiology intensive care radiologyStenosis3121 General medicine internal medicine and other clinical medicineConventional PCIST Elevation Myocardial Infarctionbusiness

description

Publisher Copyright: © 2021 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 (α = .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. Peer reviewed

yearjournalcountryeditionlanguage
2021-11-01
10.1016/j.ahj.2021.07.007http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-458518