Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease.
Aged
Coronary Angiography
/ methods
Coronary Artery Bypass
/ adverse effects
Coronary Artery Disease
/ diagnosis
Coronary Stenosis
/ diagnostic imaging
Coronary Vessels
/ diagnostic imaging
Early Termination of Clinical Trials
Female
Fractional Flow Reserve, Myocardial
/ physiology
Humans
Long Term Adverse Effects
/ mortality
Male
Percutaneous Coronary Intervention
/ adverse effects
Postoperative Complications
/ mortality
Predictive Value of Tests
Risk Assessment
/ methods
Severity of Illness Index
coronary artery disease
coronary revascularization strategy
fractional flow reserve
Journal
Journal of the American College of Cardiology
ISSN: 1558-3597
Titre abrégé: J Am Coll Cardiol
Pays: United States
ID NLM: 8301365
Informations de publication
Date de publication:
09 11 2021
09 11 2021
Historique:
received:
22
07
2021
revised:
17
08
2021
accepted:
18
08
2021
entrez:
5
11
2021
pubmed:
6
11
2021
medline:
4
1
2022
Statut:
ppublish
Résumé
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. 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. 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. 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). 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).
Sections du résumé
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).
Identifiants
pubmed: 34736563
pii: S0735-1097(21)06221-5
doi: 10.1016/j.jacc.2021.08.061
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT01881555']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1875-1885Investigateurs
Laurent Leborgne
(L)
Alexandre Fournier
(A)
Geneviève Jarry
(G)
François Leleu
(F)
Dorothée Malaquin
(D)
Anfani Mirode
(A)
Loïc Belle
(L)
Lionel Mangin
(L)
Nathalie Noirclerc
(N)
Pierre Barnay
(P)
Jean-Lou Hirsch
(JL)
Marc Metge
(M)
Michel Pansiery
(M)
FrançoisXavier Soto
(F)
Antoine Boge
(A)
Kamel HadjHamou
(K)
Ichem Miliani
(I)
Guillaume Molins
(G)
Stéphane Mourot
(S)
Marion Pelletier
(M)
Olivier Ressencourt
(O)
Frédéric Schaad
(F)
Pierre Coste
(P)
Warren Chasseriaud
(W)
Laura Cetran
(L)
Pierre Poustis
(P)
Laura Cetran
(L)
Jean-Francois Morelle
(JF)
Franck Albert
(F)
Thibaud Demicheli
(T)
Grégroire Range
(G)
Christophe Thuaire
(C)
Pascal Motreff
(P)
Nicolas Barber-Chamoux
(N)
Nicolas Combaret
(N)
Guilhem Malclès
(G)
Géraud Souteyrand
(G)
Yves Cottin
(Y)
Philippe Buffet
(P)
Aurélie Gudjonvick
(A)
Isabelle L'Huillier
(I)
Luc Lorgis
(L)
Carole Richard
(C)
Bernard Bertrand
(B)
Gilles Baronne-Rochette
(G)
Hélène Bouvaist
(H)
Stéphanie Marlière
(S)
Olivier Ormezzano
(O)
Gérald Vanzetto
(G)
Ludovic Meunier
(L)
Charlotte Trouillet
(C)
Yann Valy
(Y)
Pierre-François Lesault
(PF)
Eric VanBelle
(E)
Christophe Bauters
(C)
Cédric Delhaye
(C)
Gilles Lemesle
(G)
Riadh Rihani
(R)
Pierre Graux
(P)
Jean-Michel Lemahieu
(JM)
Brahim Harbaoui
(B)
Cyril Besnard
(C)
Pierre-Yves Courand
(PY)
Raphaël Dauphin
(R)
Pierre Lantelme
(P)
Thibault Perret
(T)
Jean-Raymond Caignault
(JR)
Olivier Dubreuil
(O)
Sylvain Ranc
(S)
Bernard Ritz
(B)
Gilles Rioufol
(G)
Cyrille Bergerot
(C)
Thomas Bochaton
(T)
Eric Bonnefoy-Cudraz
(E)
Didier Bresson
(D)
Julie Dementhon
(J)
François Derimay
(F)
Gérard Finet
(G)
Lisa Green
(L)
Cyril Prieur
(C)
Ingrid Sanchez
(I)
Oualid Zouaghi
(O)
Sébastien Arméro
(S)
Thierry Lefèvre
(T)
Hakim Ben-Amer
(H)
Bernard Chevalier
(B)
Philippe Garot
(P)
Thomas Hovasse
(T)
Yves Louvard
(Y)
Marie-Claude Morice
(MC)
Oscar Tavolaro
(O)
Thierry Unterseeh
(T)
Patrick Dupouy
(P)
François Roubille
(F)
DinhThienTri Cung
(D)
Jean-Christophe Macia
(JC)
Christophe Piot
(C)
Gilles Levy
(G)
Olivier Roth
(O)
Didier Bresson
(D)
Laurent Jacquemin
(L)
Jean-Yves Wiedemann
(JY)
Guillaume Cayla
(G)
Luc Cornillet
(L)
Bertrand Ledermann
(B)
Laurent Schmutz
(L)
Antoine Lafont
(A)
Nicole Karam
(N)
Saliha Rahal
(S)
Christophe Caussin
(C)
Nicolas Amabile
(N)
Philippe Girard
(P)
Aurélie Veugeois
(A)
Olivier Barthélémy
(O)
Jean-Philippe Collet
(JP)
Gilles Montalescot
(G)
René Koning
(R)
Jacques Berland
(J)
Matthieu Godin
(M)
Quentin Landolff
(Q)
Bilel Zoghlami
(B)
Christophe Pouillot
(C)
Karim Bougrini
(K)
Christophe Geyer
(C)
Jens Glanenapp
(J)
Patrick Mascarel
(P)
Geoffray Rambaud
(G)
Richard ViFane
(R)
Denis Angoulvant
(D)
Bernard Desveaux
(B)
Fabrice Ivanes
(F)
Gérard Pacouret
(G)
Laurent-Emmanuel Quilliet
(LE)
Christophe SaintEtienne
(C)
Philippe Chapon
(P)
Christophe Bretelle
(C)
Stanislas Champin
(S)
Commentaires et corrections
Type : CommentIn
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Type : CommentIn
Informations de copyright
Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
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.