Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease
Gilles Rioufol, François Dérimay, François Roubille, Thibault Perret, Pascal Motreff, Denis Angoulvant, Yves Cottin, Ludovic Meunier, Laura Cetran, Guillaume Cayla, Brahim Harbaoui, Jean-Yves Wiedemann, Éric Van Belle, Christophe Pouillot, Nathalie Noirclerc, Jean-François Morelle, François-Xavier Soto, Christophe Caussin, Bernard Bertrand, Thierry Lefèvre, Patrick Dupouy, Pierre-François Lesault, Franck Albert, Olivier Barthelemy, René Koning, Laurent Leborgne, Pierre Barnay, Philippe Chapon, Sébastien Armero, Antoine Lafont, Christophe Piot, Camille Amaz, Bernadette Vaz, Lakhdar Benyahya, Yvonne Varillon, Michel Ovize, Nathan Mewton, Gérard Finet, FUTURE Trial Investigators, Laurent Leborgne, Alexandre Fournier, Geneviève Jarry, François Leleu, Dorothée Malaquin, Anfani Mirode, Loïc Belle, Lionel Mangin, Nathalie Noirclerc, Pierre Barnay, Jean-Lou Hirsch, Marc Metge, Michel Pansiery, FrançoisXavier Soto, Antoine Boge, Kamel HadjHamou, Ichem Miliani, Guillaume Molins, Stéphane Mourot, Marion Pelletier, Olivier Ressencourt, Frédéric Schaad, Pierre Coste, Warren Chasseriaud, Laura Cetran, Pierre Poustis, Laura Cetran, Jean-Francois Morelle, Franck Albert, Thibaud Demicheli, Grégroire Range, Christophe Thuaire, Pascal Motreff, Nicolas Barber-Chamoux, Nicolas Combaret, Guilhem Malclès, Géraud Souteyrand, Yves Cottin, Philippe Buffet, Aurélie Gudjonvick, Isabelle L'Huillier, Luc Lorgis, Carole Richard, Bernard Bertrand, Gilles Baronne-Rochette, Hélène Bouvaist, Stéphanie Marlière, Olivier Ormezzano, Gérald Vanzetto, Ludovic Meunier, Charlotte Trouillet, Yann Valy, Pierre-François Lesault, Eric VanBelle, Christophe Bauters, Cédric Delhaye, Gilles Lemesle, Riadh Rihani, Pierre Graux, Jean-Michel Lemahieu, Brahim Harbaoui, Cyril Besnard, Pierre-Yves Courand, Raphaël Dauphin, Pierre Lantelme, Thibault Perret, Jean-Raymond Caignault, Olivier Dubreuil, Sylvain Ranc, Bernard Ritz, Gilles Rioufol, Cyrille Bergerot, Thomas Bochaton, Eric Bonnefoy-Cudraz, Didier Bresson, Julie Dementhon, François Derimay, Gérard Finet, Lisa Green, Cyril Prieur, Ingrid Sanchez, Oualid Zouaghi, Sébastien Arméro, Thierry Lefèvre, Hakim Ben-Amer, Bernard Chevalier, Philippe Garot, Thomas Hovasse, Yves Louvard, Marie-Claude Morice, Oscar Tavolaro, Thierry Unterseeh, Patrick Dupouy, François Roubille, DinhThienTri Cung, Jean-Christophe Macia, Christophe Piot, Gilles Levy, Olivier Roth, Didier Bresson, Laurent Jacquemin, Jean-Yves Wiedemann, Guillaume Cayla, Luc Cornillet, Bertrand Ledermann, Laurent Schmutz, Antoine Lafont, Nicole Karam, Saliha Rahal, Christophe Caussin, Nicolas Amabile, Philippe Girard, Aurélie Veugeois, Olivier Barthélémy, Jean-Philippe Collet, Gilles Montalescot, René Koning, Jacques Berland, Matthieu Godin, Quentin Landolff, Bilel Zoghlami, Christophe Pouillot, Karim Bougrini, Christophe Geyer, Jens Glanenapp, Patrick Mascarel, Geoffray Rambaud, Richard ViFane, Denis Angoulvant, Bernard Desveaux, Fabrice Ivanes, Gérard Pacouret, Laurent-Emmanuel Quilliet, Christophe SaintEtienne, Philippe Chapon, Christophe Bretelle, Stanislas Champin, Gilles Rioufol, François Dérimay, François Roubille, Thibault Perret, Pascal Motreff, Denis Angoulvant, Yves Cottin, Ludovic Meunier, Laura Cetran, Guillaume Cayla, Brahim Harbaoui, Jean-Yves Wiedemann, Éric Van Belle, Christophe Pouillot, Nathalie Noirclerc, Jean-François Morelle, François-Xavier Soto, Christophe Caussin, Bernard Bertrand, Thierry Lefèvre, Patrick Dupouy, Pierre-François Lesault, Franck Albert, Olivier Barthelemy, René Koning, Laurent Leborgne, Pierre Barnay, Philippe Chapon, Sébastien Armero, Antoine Lafont, Christophe Piot, Camille Amaz, Bernadette Vaz, Lakhdar Benyahya, Yvonne Varillon, Michel Ovize, Nathan Mewton, Gérard Finet, FUTURE Trial Investigators, Laurent Leborgne, Alexandre Fournier, Geneviève Jarry, François Leleu, Dorothée Malaquin, Anfani Mirode, Loïc Belle, Lionel Mangin, Nathalie Noirclerc, Pierre Barnay, Jean-Lou Hirsch, Marc Metge, Michel Pansiery, FrançoisXavier Soto, Antoine Boge, Kamel HadjHamou, Ichem Miliani, Guillaume Molins, Stéphane Mourot, Marion Pelletier, Olivier Ressencourt, Frédéric Schaad, Pierre Coste, Warren Chasseriaud, Laura Cetran, Pierre Poustis, Laura Cetran, Jean-Francois Morelle, Franck Albert, Thibaud Demicheli, Grégroire Range, Christophe Thuaire, Pascal Motreff, Nicolas Barber-Chamoux, Nicolas Combaret, Guilhem Malclès, Géraud Souteyrand, Yves Cottin, Philippe Buffet, Aurélie Gudjonvick, Isabelle L'Huillier, Luc Lorgis, Carole Richard, Bernard Bertrand, Gilles Baronne-Rochette, Hélène Bouvaist, Stéphanie Marlière, Olivier Ormezzano, Gérald Vanzetto, Ludovic Meunier, Charlotte Trouillet, Yann Valy, Pierre-François Lesault, Eric VanBelle, Christophe Bauters, Cédric Delhaye, Gilles Lemesle, Riadh Rihani, Pierre Graux, Jean-Michel Lemahieu, Brahim Harbaoui, Cyril Besnard, Pierre-Yves Courand, Raphaël Dauphin, Pierre Lantelme, Thibault Perret, Jean-Raymond Caignault, Olivier Dubreuil, Sylvain Ranc, Bernard Ritz, Gilles Rioufol, Cyrille Bergerot, Thomas Bochaton, Eric Bonnefoy-Cudraz, Didier Bresson, Julie Dementhon, François Derimay, Gérard Finet, Lisa Green, Cyril Prieur, Ingrid Sanchez, Oualid Zouaghi, Sébastien Arméro, Thierry Lefèvre, Hakim Ben-Amer, Bernard Chevalier, Philippe Garot, Thomas Hovasse, Yves Louvard, Marie-Claude Morice, Oscar Tavolaro, Thierry Unterseeh, Patrick Dupouy, François Roubille, DinhThienTri Cung, Jean-Christophe Macia, Christophe Piot, Gilles Levy, Olivier Roth, Didier Bresson, Laurent Jacquemin, Jean-Yves Wiedemann, Guillaume Cayla, Luc Cornillet, Bertrand Ledermann, Laurent Schmutz, Antoine Lafont, Nicole Karam, Saliha Rahal, Christophe Caussin, Nicolas Amabile, Philippe Girard, Aurélie Veugeois, Olivier Barthélémy, Jean-Philippe Collet, Gilles Montalescot, René Koning, Jacques Berland, Matthieu Godin, Quentin Landolff, Bilel Zoghlami, Christophe Pouillot, Karim Bougrini, Christophe Geyer, Jens Glanenapp, Patrick Mascarel, Geoffray Rambaud, Richard ViFane, Denis Angoulvant, Bernard Desveaux, Fabrice Ivanes, Gérard Pacouret, Laurent-Emmanuel Quilliet, Christophe SaintEtienne, Philippe Chapon, Christophe Bretelle, Stanislas Champin
Abstract
Background: There is limited evidence that fractional flow reserve (FFR) is effective in guiding therapeutic strategy in multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates.
Objectives: The FUTURE (FUnctional Testing Underlying coronary REvascularization) trial aimed to evaluate whether a treatment strategy based on FFR was superior to a traditional strategy without FFR in the treatment of multivessel CAD.
Methods: The FUTURE trial is a prospective, randomized, open-label superiority trial. Multivessel CAD candidates were randomly assigned (1:1) to treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR. In the FFR group, revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events at 1 year.
Results: The trial was stopped prematurely by the data safety and monitoring board after a safety analysis and 927 patients were enrolled. At 1-year follow-up, by intention to treat, there were no significant differences in major adverse cardiac or cerebrovascular events rates between groups (14.6% in the FFR group vs 14.4% in the control group; hazard ratio: 0.97; 95% confidence interval: 0.69-1.36; P = 0.85). The difference in all-cause mortality was nonsignificant, 3.7% in the FFR group versus 1.5% in the control group (hazard ratio: 2.34; 95% confidence interval: 0.97-5.18; P = 0.06), and this was confirmed with a 24 months' extended follow-up. FFR significantly reduced the proportion of revascularized patients, with more patients referred to exclusively medical treatment (P = 0.02).
Conclusions: In patients with multivessel CAD, we did not find evidence that an FFR-guided treatment strategy reduced the risk of ischemic cardiovascular events or death at 1-year follow-up. (Functional Testing Underlying Coronary Revascularisation; NCT01881555).
Keywords: coronary artery disease; coronary revascularization strategy; fractional flow reserve.
Conflict of interest statement
Funding Support and Author Disclosures This work was supported by an academic grant (Programme Hospitalier de Recherche Clinique National) from the French Government, and the Hospices Civils de Lyon was the academic sponsor, involved in the collection and verification of all the study data. St Jude Medical and Volcano provided 46% of fractional flow reserve wires without any charge. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed