• N. Engl. J. Med. · Apr 2024

    Randomized Controlled Trial Multicenter Study Comparative Study

    FFR-Guided Complete or Culprit-Only PCI in Patients with Myocardial Infarction.

    • Felix Böhm, Brynjölfur Mogensen, Thomas Engstrøm, Goran Stankovic, Ilija Srdanovic, Jacob Lønborg, Sammy Zwackman, Mehmet Hamid, Thomas Kellerth, Jörg Lauermann, Olli A Kajander, Jonas Andersson, Rikard Linder, Oskar Angerås, Henrik Renlund, Andrejs Ērglis, Madhav Menon, Carl Schultz, Mika Laine, Claes Held, Andreas Rück, Ollie Östlund, Stefan James, and FULL REVASC Trial Investigators.
    • From the Department of Cardiology, Karolinska Institute and Danderyd Hospital, Danderyd (F.B., B.M., R.L.), the Department of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (A.R.), the Department of Cardiology, Linköping University Hospital, Linköping (S.Z.), the Department of Cardiology, Mälarsjukhuset, Eskilstuna (M.H.), the Department of Cardiology, Central Hospital, Karlstad (T.K.), the Department of Cardiology, Ryhov Hospital, Jönköping (J. Lauermann), the Department of Cardiology, Umeå University Hospital, Umeå (J.A.), the Department of Cardiology, Sahlgrenska University Hospital, and the Department of Molecular and Clinical Medicine, Institute of Medicine, Gothenburg University, Gothenburg (O.A.), and the Department of Medical Sciences, Cardiology (H.R., C.H., O.Ö., S.J.), and Uppsala Clinical Research Center (C.H., S.J.), Uppsala University, Uppsala - all in Sweden; the Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen (T.E., J. Lønborg); the University Clinical Center of Serbia and the Faculty of Medicine, University of Belgrade, Belgrade (G.S.), and the Faculty of Medicine, University of Novi Sad, Institute of Cardiovascular Diseases Vojvodina, Sremska Kamenica (I.S.) - all in Serbia; the Heart Hospital, Tampere University Hospital, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), and the Heart and Lung Center, Helsinki University Central Hospital, Helsinki (M.L.) - all in Finland; the Latvian Center of Cardiology, Pauls Stradins Clinical University Hospital, University of Latvia, Riga (A..); the Cardiology Department, Waikato Hospital, Hamilton, New Zealand (M.M.); and the Medical School, University of Western Australia, and the Department of Cardiology, Royal Perth Hospital - both in Perth, WA (C.S.).
    • N. Engl. J. Med. 2024 Apr 25; 390 (16): 148114921481-1492.

    BackgroundThe benefit of fractional flow reserve (FFR)-guided complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease remains unclear.MethodsIn this multinational, registry-based, randomized trial, we assigned patients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel disease who were undergoing primary percutaneous coronary intervention (PCI) of the culprit lesion to receive either FFR-guided complete revascularization of nonculprit lesions or no further revascularization. The primary outcome was a composite of death from any cause, myocardial infarction, or unplanned revascularization. The two key secondary outcomes were a composite of death from any cause or myocardial infarction and unplanned revascularization.ResultsA total of 1542 patients underwent randomization, with 764 assigned to receive FFR-guided complete revascularization and 778 assigned to receive culprit-lesion-only PCI. At a median follow-up of 4.8 years (interquartile range, 4.3 to 5.2), a primary-outcome event had occurred in 145 patients (19.0%) in the complete-revascularization group and in 159 patients (20.4%) in the culprit-lesion-only group (hazard ratio, 0.93; 95% confidence interval [CI], 0.74 to 1.17; P = 0.53). With respect to the secondary outcomes, no apparent between-group differences were observed in the composite of death from any cause or myocardial infarction (hazard ratio, 1.12; 95% CI, 0.87 to 1.44) or unplanned revascularization (hazard ratio, 0.76; 95% CI, 0.56 to 1.04). There were no apparent between-group differences in safety outcomes.ConclusionsAmong patients with STEMI or very-high-risk NSTEMI and multivessel coronary artery disease, FFR-guided complete revascularization was not shown to result in a lower risk of a composite of death from any cause, myocardial infarction, or unplanned revascularization than culprit-lesion-only PCI at 4.8 years. (Funded by the Swedish Research Council and others; FULL REVASC ClinicalTrials.gov number, NCT02862119.).Copyright © 2024 Massachusetts Medical Society.

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