Three-Year Outcomes With Fractional Flow Reserve–Guided or Angiography-Guided Multivessel Percutaneous Coronary Intervention for Myocardial Infarction

Author:

Puymirat Etienne123ORCID,Cayla Guillaume4ORCID,Simon Tabassome356ORCID,Steg Philippe Gabriel37ORCID,Montalescot Gilles8ORCID,Durand-Zaleski Isabelle9ORCID,Ngaleu Siaha Fabiola9,Gallet Romain1011,Khalife Khalife12,Morelle Jean-François13,Motreff Pascal14,Lemesle Gilles31516ORCID,Dillinger Jean-Guillaume17ORCID,Lhermusier Thibault1819ORCID,Silvain Johanne8ORCID,Roule Vincent20ORCID,Labèque Jean-Noel21,Rangé Grégoire22ORCID,Ducrocq Grégory2323ORCID,Cottin Yves2425ORCID,Blanchard Didier12,Charles Nelson Anaïs26,Djadi-Prat Juliette26ORCID,Chatellier Gilles26ORCID,Danchin Nicolas123ORCID,

Affiliation:

1. Department of Cardiology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital européen Georges Pompidou, France (E.P., D.B., N.D.).

2. Université de Paris, France (E.P., D.B., N.D., G.D.).

3. French Alliance for Cardiovascular Trials, Paris, France (E.P., T.S., P.G.S., G.L., G.D., N.D.).

4. Centre Hospitalier Universitaire de Nîmes, France (G.C.).

5. Department of Clinical Pharmacology, AP-HP, Hôpital Saint Antoine, Unité de Recherche Clinique, France (T.S.).

6. Université Pierre et Marie Curie (UPMC-Paris 06), INSERM U-698, Paris, France (T.S.).

7. Université de Paris, INSERM Unité-1148, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.).

8. Sorbonne Université, ACTION Study Group, Institut de Cardiologie (APHP), INSERM UMRS 1166, Paris, France (G.M., J.S.).

9. Clinical Research Unit Eco Ile de France, Hôpital Hôtel Dieu, AP-HP, France (I.D.-Z., F.N.S.).

10. Service de Cardiologie, APHP, Hôpitaux Universitaires Henri Mondor, Créteil, France (R.G.).

11. U955-IMRB, Equipe 03, Inserm, Univ Paris Est Creteil, École Nationale Vétérinaire D’Alfort, Maisons-Alfort, France (R.G.).

12. Hôpital du Bon Secours, Metz, France (K.K.).

13. Clinique St. Martin, Caen, France (J.-F.M.).

14. Department of Cardiology, CHU Clermont-Ferrand, CNRS, UMR 6602, Université Clermont Auvergne, France (P.M.).

15. Cardiac Intensive Care Unit, Heart and Lung Institute, CHU Lille, France (G.L.).

16. Heart and Lung Institute, University Hospital of Lille, Institut Pasteur of Lille, Inserm, France (G.L.).

17. Department of Cardiology, Hôpital Lariboisière, AP-HP, Inserm U-942, Université de Paris, France (J.-G.D.).

18. Department of Cardiology, Intensive Cardiac Care Unit, Rangueil University Hospital, Toulouse, France (T.L.).

19. Medical School, Toulouse III Paul Sabatier University, France (T.L.).

20. Cardiology Department, Caen University Hospital, France (V.R.).

21. GCS de Cardiologie de la Côte Basque, CH Bayonne, France (J.-N.L.).

22. Cardiology Department, Les Hôpitaux de Chartres, France (G.R.).

23. Department of Cardiology, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, French Alliance for Cardiovascular Trials, INSERM U1148, Laboratory for Vascular Translational Science, France (G.D.).

24. Physiopathologie et Epidémiologie Cérébro-Cardiovasculaires, EA 7460, University of Bourgogne Franche-Comté, Dijon, France (Y.C.).

25. Cardiology Department, University Hospital Centre of Dijon Bourgogne, Dijon, France (Y.C.).

26. Clinical Research Unit, George-Pompidou European Hospital, AP-HP, CIC-EC1418, Inserm, France (A.C.N., J.D.-P., G.C.).

Abstract

BACKGROUND: In patients with multivessel disease with successful primary percutaneous coronary intervention for ST-segment–elevation myocardial infarction, the FLOWER-MI trial (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) showed that a fractional flow reserve (FFR)–guided strategy was not superior to an angiography-guided strategy for treatment of noninfarct-related artery lesions regarding the 1-year risk of death from any cause, myocardial infarction, or unplanned hospitalization leading to urgent revascularization. The extension phase of the trial was planned using the same primary outcome to determine whether a difference in outcomes would be observed with a longer follow-up. METHODS: In this multicenter trial, we randomly assigned patients with ST-segment–elevation myocardial infarction and multivessel disease with successful percutaneous coronary intervention of the infarct-related artery to receive complete revascularization guided by either FFR (n=586) or angiography (n=577). RESULTS: After 3 years, a primary outcome event occurred in 52 of 498 patients (9.40%) in the FFR-guided group and in 44 of 502 patients (8.17%) in the angiography-guided group (hazard ratio, 1.19 [95% CI, 0.79–1.77]; P =0.4). Death occurred in 22 patients (4.00%) in the FFR-guided group and in 23 (4.32%) in the angiography-guided group (hazard ratio, 0.96 [95% CI, 0.53–1.71]); nonfatal myocardial infarction in 23 (4.13%) and 14 (2.56%), respectively (hazard ratio, 1.63 [95% CI, 0.84–3.16]); and unplanned hospitalization leading to urgent revascularization in 21 (3.83%) and 18 (3.36%; hazard ratio, 1.15 [95% CI, 0.61–2.16]), respectively. CONCLUSIONS: Although event rates in the trial were lower than expected, in patients with ST-segment–elevation myocardial infarction 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 up to 3 years. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02943954.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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