Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction.
Aged
Confidence Intervals
Coronary Angiography
Coronary Stenosis
/ surgery
Female
Follow-Up Studies
Fractional Flow Reserve, Myocardial
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Myocardial Revascularization
/ methods
Percutaneous Coronary Intervention
/ methods
Proportional Hazards Models
ST Elevation Myocardial Infarction
/ mortality
Single-Blind Method
Stents
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
22 07 2021
22 07 2021
Historique:
pubmed:
18
5
2021
medline:
29
7
2021
entrez:
17
5
2021
Statut:
ppublish
Résumé
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. 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. The mean (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 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. 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.).
Sections du résumé
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
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 (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 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.).
Identifiants
pubmed: 33999545
doi: 10.1056/NEJMoa2104650
doi:
Banques de données
ClinicalTrials.gov
['NCT02943954']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
297-308Subventions
Organisme : Abbott Laboratories
ID : Grant
Investigateurs
Etienne Puymirat
(E)
Loic Belle
(L)
Anne Bellemain-Apaix
(A)
Jean-Noel Labeque
(JN)
Francois Schiele
(F)
Pierre Coste
(P)
Marie Hauguel-Moreau
(M)
Martine Gilard
(M)
Eric Bonnefoy-Cudraz
(E)
Vincent Roule
(V)
Jean-Francois Morelle
(JF)
Pascal Goube
(P)
Jerome Clerc
(J)
Brahim Harbaoui
(B)
Sylvain Ranc
(S)
Range Gregoire
(R)
Pascal Motreff
(P)
Emmanuel Teiger
(E)
Yves Cottin
(Y)
Gerald Vanzetto
(G)
Yann Valy
(Y)
Remy Cohen
(R)
Marc Antoine Isorni
(MA)
Jean-Marie Perron
(JM)
Eric Van Belle
(EV)
Thomas Cuisset
(T)
Laurent Bonello
(L)
Thierry Lefevre
(T)
Khalife Khalife
(K)
Olivier Nallet
(O)
Francois Roubille
(F)
Edoardo Camenzind
(E)
Vincent Letocart
(V)
Guillaume Cayla
(G)
Gregory Ducrocq
(G)
Johanne Silvain
(J)
Jean-Guillaume Dillinger
(JG)
Olivier Varenne
(O)
Nicolas Delarche
(N)
Lebreton Herve
(L)
Eric Durand
(E)
Patrick Ohlmann
(P)
Thibault L'hermusier
(T)
Jean Fajadet
(J)
Stephan Chassaing
(S)
Denis Angoulvant
(D)
David Houpe
(D)
Bernard Livarek
(B)
Aures Chaib
(A)
Gabin Legros
(G)
Sebastien Levesque
(S)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
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