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Original ArticleFree Preview

Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction

List of authors.
  • Etienne Puymirat, M.D., Ph.D.,
  • Guillaume Cayla, M.D., Ph.D.,
  • Tabassome Simon, M.D., Ph.D.,
  • Philippe G. Steg, M.D.,
  • Gilles Montalescot, M.D., Ph.D.,
  • Isabelle Durand-Zaleski, M.D., Ph.D.,
  • Alicia le Bras, M.D.,
  • Romain Gallet, M.D., Ph.D.,
  • Khalife Khalife, M.D.,
  • Jean-Fran?ois Morelle, M.D.,
  • Pascal Motreff, M.D., Ph.D.,
  • Gilles Lemesle, M.D., Ph.D.,
  • Jean-Guillaume Dillinger, M.D., Ph.D.,
  • Thibault Lhermusier, M.D., Ph.D.,
  • Johanne Silvain, M.D., Ph.D.,
  • Vincent Roule, M.D., Ph.D.,
  • Jean-Noel Lab¨¨que, M.D.,
  • Gr¨¦goire Rang¨¦, M.D.,
  • Gr¨¦gory Ducrocq, M.D., Ph.D.,
  • Yves Cottin, M.D.,
  • Didier Blanchard, M.D.,
  • Ana?s Charles Nelson, N.D.,
  • Bernard De Bruyne, M.D., Ph.D.,
  • Gilles Chatellier, M.D.,
  • and Nicolas Danchin, M.D.
  • for the FLOWER-MI Study Investigators*

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

Download a PDF of the Research Summary.

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 (¡ÀSD) number of stents that were placed per patient for nonculprit lesions was 1.01¡À0.99 in the FFR-guided group and 1.50¡À0.86 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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Multivessel PCI Guided by FFR or Angiography for MI
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Funding and Disclosures

Supported by a grant from the French Ministry of Health and an unrestricted grant from Abbott.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Dr. Puymirat reports receiving lecture fees from Abbott, Amgen, Bristol Myers Squibb, Biotronik, Daiichi Sankyo, Eli Lilly, and Pfizer, consulting fees, lecture fees, and travel support from AstraZeneca, MSD, and Servier, grant support, consulting fees, and lecture fees from Bayer, and consulting fees and lecture fees from Boehringer Ingelheim, Novartis, and Sanofi; Dr. Cayla, receiving lecture fees from AstraZeneca, Biotronik, Bristol Myers Squibb, Pfizer, Sanofi, and Microport and grant support, paid to his institution, and lecture fees from Medtronic; Dr. Simon, receiving grant support, fees for executive board membership, and lecture fees from AstraZeneca, consulting fees from Ablative Solutions, grant support and advisory board fees from Bayer and Novartis, grant support, fees for board membership, and consulting fees from Sanofi, grant support from Boehringer Ingelheim, Eli Lilly, and GSK; Dr. Steg, receiving grant support and steering committee fees from Amarin, consulting fees and lecture fees from Amgen and Novo Nordisk, consulting fees, lecture fees, and travel support from AstraZeneca, lecture fees and steering committee fees from Bayer and Bristol Myers Squibb, steering committee fees from Boehringer Ingelheim, Idorsia, and Lexicon, consulting fees, steering committee fees, and lecture fees from Novartis, critical event committee fees from Pfizer, grant support and fees for serving as a registry chair from Servier, consulting fees from Myokardia, grant support, fees for serving as trial cochair, and steering committee fees from Sanofi, consulting fees and fees for serving as trial cochair from Regeneron, and holding patent 14/657,192 on alirocumab for cardiovascular risk reduction, licensed to Sanofi; Dr. Montalescot, receiving grant support, lecture fees, and consulting fees from Abbott, Amgen, AstraZeneca, Bayer, Boston Scientific, Bristol Myers Squibb, Servier, Novartis, Quantum Genomics, and Sanofi-Aventis, lecture fees and consulting fees from Boehringer Ingelheim, Cell-Prothera, and Europa, and grant support from COR2ED, CSL Behring, Idorsia, Medtronic, MSD, and Pfizer; Dr. Durand-Zaleski, receiving consulting fees and lecture fees from Boston Scientific and Medtronic; Dr. Motreff, receiving consulting fees and lecture fees from Abbott Vascular; Dr. Lemesle, receiving consulting fees and lecture fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, MSD, Daiichi Sankyo, Eli Lilly, Mylan, Novartis, Novo Nordisk, Pfizer, Sanofi Aventis, and Servier; Dr. Lhermusier, receiving consulting fees and lecture fees from Abbott and Boston Scientific; Dr. Silvain, receiving grant support, lecture fees, and consulting fees from AstraZeneca France, travel support from Abbott Medical France and Terumo France, lecture fees and consulting fees from Bayer HealthCare, Boehringer Ingelheim, BPI France, CSL Behring, Gilead Science, Sanofi Aventis, and Zoll, and owning stock in 4P-Pharma; Dr. Roule, receiving consulting fees and lecture fees from Bristol Myers Squibb and Pfizer; Dr. Ducrocq, receiving consulting fees and lecture fees from Amgen, Janssen, Sanofi, Terumo, and Novo Nordisk and consulting fees, lecture fees, and travel support from AstraZeneca, Bayer, and Bristol Myers Squibb; Dr. Cottin, receiving consulting fees and lecture fees from Servier, Novartis, AstraZeneca, Pfizer, Boehringer Ingelheim, and Bristol Myers Squibb; Dr. De Bruyne, receiving grant support from Abbott Vascular and Boston Scientific and holding equity in Opsens, HeartFlow, GE, Siemens, Edwards Lifesciences, Celyad, Bayer, Sanofi, and Philips; and Dr. Danchin, receiving grant support, consulting fees, lecture fees, and travel support from Amgen, AstraZeneca, Bayer, and Bristol Myers Squibb, lecture fees from Boehringer Ingelheim, Intercept, MSD, and Novartis, grant support, consulting fees, and lecture fees from Sanofi, steering committee fees from Servier, consulting fees from Novo Nordisk and UCB, and critical events committee membership fees from Vifor. No other potential conflict of interest relevant to this article was reported.

This article was published on May 16, 2021, at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

We thank all the patients who participated in the trial and the physicians who took care of the patients at the participating institutions; and Juliette Djadi-Prat, Shohreh Azimi, Aurelia Dinut, Hakima Manseur, Hasina Rakotosamimanana, Axel Bouffier, Hajar Chouiki, Lynda Arab, Nivetha Atputhanathan, Hasina Rabetrano, Od¨¦lia Bitton, Sabrina Boudif, Salima Bouslah, Myriam Calvet, Alexandre Cuquemelle, Meriem Damouche, Sarra Elouaret, Sabrina Fiori, Muriel Gernet, Fatiha Khedim, and Rana Korbi for their help in managing the trial.

Author Affiliations

From Assistance Publique¨CH?pitaux de Paris (AP-HP), Department of Cardiology, H?pital Europ¨¦en Georges Pompidou, Universit¨¦ de Paris, INSERM, Paris Centre de Recherche Cardiovasculaire (E.P., D.B., N.D.), AP-HP, H?pital Saint Antoine, Department of Clinical Pharmacology and Unit¨¦ de Recherche Clinique, Sorbonne Universit¨¦, INSERM Unit¨¦ 698 (T.S.), Universit¨¦ de Paris, INSERM Unit¨¦ 1148, and H?pital Bichat, AP-HP (P.G.S.), Sorbonne Universit¨¦, ACTION Study Group, Institut de Cardiologie (AP-HP), INSERM UMRS 1166, H?pital Piti¨¦¨CSalp¨ºtri¨¨re (G.M., J.S.), Clinical Research Unit Eco Ile de France, H?pital H?tel Dieu, AP-HP (I.D.-Z., A.B.), the Department of Cardiology, H?pital Lariboisi¨¨re, AP-HP, INSERM Unit¨¦ 942, Universit¨¦ de Paris (J.-G.D.), the Department of Cardiology, H?pital Bichat, AP-HP, French Alliance for Cardiovascular Trials, INSERM Unit¨¦ 1148, Laboratory for Vascular Translational Science, Universit¨¦ 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 N?mes, N?mes (G. Cayla), Service de Cardiologie, AP-HP, Universit¨¦ de Paris Est Cr¨¦teil, H?pitaux Universitaires Henri Mondor, Cr¨¦teil, and Unit¨¦ 955¨CMondor Institute for Biomedical Research, Equipe 03, INSERM, Ecole Nationale V¨¦t¨¦rinaire d¡¯Alfort, Maisons-Alfort (R.G.), H?pital 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, Universit¨¦ 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 Unit¨¦ 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 Coop¨¦ration Saintaire de Cardiologie de la C?te Basque, Centre Hospitalier de la C?te Basque, Bayonne (J.-N.L.), the Cardiology Department, H?pitaux de Chartres, Chartres (G.R.), and Physiopathologie et Epid¨¦miologie C¨¦r¨¦bro-Cardiovasculaires, Equipe d¡¯Accueil (EA 7460), University of Bourgogne Franche-Comt¨¦, and the Cardiology Department, University Hospital Center of Dijon Bourgogne, Dijon (Y.C.) ¡ª 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.).

Address reprint requests to Dr. Puymirat at the Department of Cardiology, H?pital Europ¨¦en Georges Pompidou, 20 rue Leblanc, 75015 Paris, France, or at .

A list of the FLOWER-MI study investigators is provided in the Supplementary Appendix, available at NEJM.org.

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