Pierre Denormandie1,2, Tabassome Simon3,4,5,6, Guillaume Cayla7, Philippe Gabriel Steg6,8, Gilles Montalescot9, Isabelle Durand-Zaleski10, Alicia le Bras10, Hervé le Breton11, Yann Valy12, François Schiele6,13,14, Thomas Cuisset15, Gérald Vanzetto6,16,17, Sébastien Levesque18, Pascal Goube19, Olivier Nallet20, Denis Angoulvant21, François Roubille22,23, Anaïs Charles Nelson24, Gilles Chatellier24, Nicolas Danchin1, Etienne Puymirat1. 1. Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, France (P.D., N.D., E.P.). 2. Université de Paris, France (P.D.). 3. AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), Paris, France (T.S.). 4. Université Pierre et Marie Curie (UPMC-Paris 06) (T.S.). 5. INSERM U-698, Paris, France (T.S.). 6. French Alliance for Cardiovascular Trials (T.S., P.G.S., F.S., G.V.). 7. Cardiology Department, Nîmes University Hospital, Montpellier University, France (G.C.). 8. INSERM Unité-1148, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Université de Paris, France (P.G.S.). 9. Sorbonne Université, ACTION Study Group, Institut de Cardiologie (APHP), INSERM UMRS 1166, Hôpital Pitié-Salpêtrière, Paris, France (G.M.). 10. Clinical Research Unit Eco Ile de France, Hôpital Hôtel Dieu, AP-HP, Paris (I.D.-Z., A.l.B.). 11. Université Rennes, CHU Rennes, Inserm, LTSI-UMR1099, France (H.l.B.). 12. Department of Cardiology, CH Saint-Louis, La Rochelle, France (Y.V.). 13. Department of Cardiology, University Hospital Besançon, France (F.S.). 14. EA 3920, University of Burgundy Franche-Comté, Besançon, France (F.S.). 15. ACTION Study Group, Cardiology Department, INSERM UMR1062, INRA UMR1260, Centre Hospitalier Universitaire La Timone, Aix-Marseille University, France (T.C.). 16. Department of Cardiology, University Hospital, 38000 Grenoble Alpes, France (G.V.). 17. INSERM U1039, Radiopharmaceutiques Biocliniques, Grenoble Alpes University, France (G.V.). 18. Cardiovascular Interventional Unit, Division of Cardiology, Department of Medicine, Centre Cardio-Vasculaire, CHU de Poitiers, France (S.L.). 19. Department of Cardiology, Centre Hospitalier Sud Francilien, Corbeil Essonne, France (P.G.). 20. Cardiology Department, Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, France (O.N.). 21. Cardiology Department and EA4245 T2i, University Hospital of Tours and Tours University, France (D.A.). 22. Department of Cardiology, Regional University Hospital of Montpellier, France (F.R.). 23. PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, France (F.R.). 24. Clinical Research Unit and CIC 1418 INSERM, George-Pompidou European Hospital, AP-HP, Paris, France (A.C.N., G.C.).
Abstract
BACKGROUND: In patients with ST-segment-elevation myocardial infarction and multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions guided by fractional flow reserve (FFR) is superior to treatment of the culprit lesion alone. Whether deferring nonculprit PCI is safe in this specific context is questionable. We aimed to assess clinical outcomes at 1 year in ST-segment-elevation myocardial infarction patients with multivessel coronary artery disease and an FFR-guided strategy for nonculprit lesions, according to whether or not ≥1 PCI was performed. METHODS: Outcomes were analyzed in patients of the randomized FLOWER-MI (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) trial in whom, after successful primary PCI, nonculprit lesions were assessed using FFR. The primary outcome was a composite of all-cause death, nonfatal myocardial infarction, and unplanned hospitalization with urgent revascularization at 1 year. RESULTS: Among 1171 patients enrolled in this study, 586 were assigned to the FFR-guided group: 388 (66%) of them had ≥1 PCI, and 198 (34%) had no PCI. Mean FFR before decision (ie, PCI or not) of nonculprit lesions was 0.75±0.10 and 0.88±0.06, respectively. During follow-up, a primary outcome event occurred in 16 of 388 patients (4.1%) in patients with PCI and in 16 of 198 patients (8.1%) in patients without PCI (adjusted hazard ratio, 0.42 [95% CI, 0.20-0.88]; P=0.02). CONCLUSIONS: In patients with ST-segment-elevation myocardial infarction undergoing complete revascularization guided by FFR measurement, those with ≥1 PCI had lower event rates at 1 year, compared with patients with deferred PCI, suggesting that deferring lesions judged relevant by visual estimation but with FFR >0.80 may not be optimal in this context. Future randomized studies are needed to confirm these data. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02943954. Graphic Abstract: A graphic abstract is available for this article.
BACKGROUND: In patients with ST-segment-elevation myocardial infarction and multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions guided by fractional flow reserve (FFR) is superior to treatment of the culprit lesion alone. Whether deferring nonculprit PCI is safe in this specific context is questionable. We aimed to assess clinical outcomes at 1 year in ST-segment-elevation myocardial infarction patients with multivessel coronary artery disease and an FFR-guided strategy for nonculprit lesions, according to whether or not ≥1 PCI was performed. METHODS: Outcomes were analyzed in patients of the randomized FLOWER-MI (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) trial in whom, after successful primary PCI, nonculprit lesions were assessed using FFR. The primary outcome was a composite of all-cause death, nonfatal myocardial infarction, and unplanned hospitalization with urgent revascularization at 1 year. RESULTS: Among 1171 patients enrolled in this study, 586 were assigned to the FFR-guided group: 388 (66%) of them had ≥1 PCI, and 198 (34%) had no PCI. Mean FFR before decision (ie, PCI or not) of nonculprit lesions was 0.75±0.10 and 0.88±0.06, respectively. During follow-up, a primary outcome event occurred in 16 of 388 patients (4.1%) in patients with PCI and in 16 of 198 patients (8.1%) in patients without PCI (adjusted hazard ratio, 0.42 [95% CI, 0.20-0.88]; P=0.02). CONCLUSIONS: In patients with ST-segment-elevation myocardial infarction undergoing complete revascularization guided by FFR measurement, those with ≥1 PCI had lower event rates at 1 year, compared with patients with deferred PCI, suggesting that deferring lesions judged relevant by visual estimation but with FFR >0.80 may not be optimal in this context. Future randomized studies are needed to confirm these data. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02943954. Graphic Abstract: A graphic abstract is available for this article.
Entities:
Keywords:
cause of death; coronary artery disease; follow-up studies; hospitalization; humans