Etienne Puymirat1, Guillaume Cayla1, Tabassome Simon1, Philippe G Steg1, Gilles Montalescot1, Isabelle Durand-Zaleski1, Alicia le Bras1, Romain Gallet1, Khalife Khalife1, Jean-François Morelle1, Pascal Motreff1, Gilles Lemesle1, Jean-Guillaume Dillinger1, Thibault Lhermusier1, Johanne Silvain1, Vincent Roule1, Jean-Noel Labèque1, Grégoire Rangé1, Grégory Ducrocq1, Yves Cottin1, Didier Blanchard1, Anaïs Charles Nelson1, Bernard De Bruyne1, Gilles Chatellier1, Nicolas Danchin1. 1. From Assistance Publique-Hôpitaux de Paris (AP-HP), Department of Cardiology, Hôpital Européen Georges Pompidou, Université de Paris, INSERM, Paris Centre de Recherche Cardiovasculaire (E.P., D.B., N.D.), AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique, Sorbonne Université, INSERM Unité 698 (T.S.), Université de Paris, INSERM Unité 1148, and Hôpital Bichat, AP-HP (P.G.S.), Sorbonne Université, ACTION Study Group, Institut de Cardiologie (AP-HP), INSERM UMRS 1166, Hôpital Pitié-Salpêtrière (G.M., J.S.), Clinical Research Unit Eco Ile de France, Hôpital Hôtel Dieu, AP-HP (I.D.-Z., A.B.), the Department of Cardiology, Hôpital Lariboisière, AP-HP, INSERM Unité 942, Université de Paris (J.-G.D.), the Department of Cardiology, Hôpital Bichat, AP-HP, French Alliance for Cardiovascular Trials, INSERM Unité 1148, Laboratory for Vascular Translational Science, Université de Paris (G.D.), the Clinical Research Unit and Centre d'Investigation Clinique 1418 INSERM, George Pompidou European Hospital, AP-HP (A.C.N., G. Chatellier), and the French Alliance for Cardiovascular Trials (E.P., T.S., P.G.S., G.L., D.B., G.D., N.D.), Paris, Centre Hospitalier Universitaire (CHU) de Nîmes, Nîmes (G. Cayla), Service de Cardiologie, AP-HP, Université de Paris Est Créteil, Hôpitaux Universitaires Henri Mondor, Créteil, and Unité 955-Mondor Institute for Biomedical Research, Equipe 03, INSERM, Ecole Nationale Vétérinaire d'Alfort, Maisons-Alfort (R.G.), Hôpital du Bon Secours, Metz (K.K.), Clinique St. Martin (J.-F.M.) and the Cardiology Department, Caen University Hospital (V.R.), Caen, the Department of Cardiology, CHU Clermont-Ferrand, CNRS UMR 6602, Université Clermont Auvergne, Clermont-Ferrand, the Cardiac Intensive Care Unit, Heart and Lung Institute, CHU Lille (P.M.), and the Heart and Lung Institute, University Hospital of Lille, Institut Pasteur of Lille, INSERM Unité 1011 (G.L.), Lille, and the Intensive Cardiac Care Unit, Department of Cardiology, Rangueil University Hospital, and the Medical School, Toulouse III Paul Sabatier University, Toulouse (T.L.), Groupement de Coopération Saintaire de Cardiologie de la Côte Basque, Centre Hospitalier de la Côte Basque, Bayonne (J.-N.L.), the Cardiology Department, Hôpitaux de Chartres, Chartres (G.R.), and Physiopathologie et Epidémiologie Cérébro-Cardiovasculaires, Equipe d'Accueil (EA 7460), University of Bourgogne Franche-Comté, and the Cardiology Department, University Hospital Center of Dijon Bourgogne, Dijon (Y.C.) - all in France; Cardiovascular Center Aalst, Aalst, Belgium (B.D.B.); and the Department of Cardiology, Lausanne University Center Hospital, Lausanne, Switzerland (B.D.B.).
Abstract
BACKGROUND: In patients with ST-elevation myocardial infarction (STEMI) who have multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions (complete revascularization) is superior to treatment of the culprit lesion alone. However, whether complete revascularization that is guided by fractional flow reserve (FFR) is superior to an angiography-guided procedure is unclear. METHODS: In this multicenter trial, we randomly assigned patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery to receive complete revascularization guided by eitherFFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year. RESULTS: The mean (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 in the angiography-guided group. During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P = 0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively. CONCLUSIONS: In patients with STEMI undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization at 1 year. However, given the wide confidence intervals for the estimate of effect, the findings do not allow for a conclusive interpretation. (Funded by the French Ministry of Health and Abbott; FLOWER-MI ClinicalTrials.gov number, NCT02943954.).
RCT Entities:
BACKGROUND: In patients with ST-elevation myocardial infarction (STEMI) who have multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions (complete revascularization) is superior to treatment of the culprit lesion alone. However, whether complete revascularization that is guided by fractional flow reserve (FFR) is superior to an angiography-guided procedure is unclear. METHODS: In this multicenter trial, we randomly assigned patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery to receive complete revascularization guided by either FFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year. RESULTS: The mean (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 in the angiography-guided group. During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P = 0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively. CONCLUSIONS: In patients with STEMI undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization at 1 year. However, given the wide confidence intervals for the estimate of effect, the findings do not allow for a conclusive interpretation. (Funded by the French Ministry of Health and Abbott; FLOWER-MI ClinicalTrials.gov number, NCT02943954.).
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