Continuation vs Discontinuation of Renin-Angiotensin System Inhibitors Before Major Noncardiac Surgery: The Stop-or-Not Randomized Clinical Trial.


Journal

JAMA
ISSN: 1538-3598
Titre abrégé: JAMA
Pays: United States
ID NLM: 7501160

Informations de publication

Date de publication:
30 Aug 2024
Historique:
pmc-release: 02 03 2025
medline: 31 8 2024
pubmed: 31 8 2024
entrez: 30 8 2024
Statut: aheadofprint

Résumé

Before surgery, the best strategy for managing patients who are taking renin-angiotensin system inhibitors (RASIs) (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) is unknown. The lack of evidence leads to conflicting guidelines. To evaluate whether a continuation strategy vs a discontinuation strategy of RASIs before major noncardiac surgery results in decreased complications at 28 days after surgery. Randomized clinical trial that included patients who were being treated with a RASI for at least 3 months and were scheduled to undergo a major noncardiac surgery between January 2018 and April 2023 at 40 hospitals in France. Patients were randomized to continue use of RASIs (n = 1107) until the day of surgery or to discontinue use of RASIs 48 hours prior to surgery (ie, they would take the last dose 3 days before surgery) (n = 1115). The primary outcome was a composite of all-cause mortality and major postoperative complications within 28 days after surgery. The key secondary outcomes were episodes of hypotension during surgery, acute kidney injury, postoperative organ failure, and length of stay in the hospital and intensive care unit during the 28 days after surgery. Of the 2222 patients (mean age, 67 years [SD, 10 years]; 65% were male), 46% were being treated with angiotensin-converting enzyme inhibitors at baseline and 54% were being treated with angiotensin receptor blockers. The rate of all-cause mortality and major postoperative complications was 22% (245 of 1115 patients) in the RASI discontinuation group and 22% (247 of 1107 patients) in the RASI continuation group (risk ratio, 1.02 [95% CI, 0.87-1.19]; P = .85). Episodes of hypotension during surgery occurred in 41% of the patients in the RASI discontinuation group and in 54% of the patients in the RASI continuation group (risk ratio, 1.31 [95% CI, 1.19-1.44]). There were no other differences in the trial outcomes. Among patients who underwent major noncardiac surgery, a continuation strategy of RASIs before surgery was not associated with a higher rate of postoperative complications than a discontinuation strategy. ClinicalTrials.gov Identifier: NCT03374449.

Identifiants

pubmed: 39212270
pii: 2823118
doi: 10.1001/jama.2024.17123
pmc: PMC11365013
doi:

Banques de données

ClinicalTrials.gov
['NCT03374449']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Investigateurs

Simon Monziols (S)
Mylene Defaye (M)
Thibault Camus (T)
Jean-Jacques Robin (JJ)
Alexandre Ouattara (A)
Ioana Fetita (I)
Olivier Joannes-Boyau (O)
Eline Bonnardel (E)
Rémi Bouquerel (R)
Antoine Strzelecki (A)
Thibaut Fayon (T)
Christophe Pelletier (C)
Benjamin LE Gaillard (B)
Thibaut Girardot (T)
Géraud Amoussou (G)
Maalik El Bouyousfi (M)
Bruno Ganascia (B)
Calliope Butrulle (C)
Soizic Gergaud (S)
Pierre Habrial (P)
Solène Pessiot (S)
Emmanuel Samson (E)
Caroline Wolff (C)
Nevena Stankova (N)
Farida Aouati (F)
Juliette Kavafyan (J)
Vlad Suparschi (V)
Dan Longrois (D)
Julie LE Roy (J)
Benoit Rossignol (B)
Olivier Huet (O)
Christophe Boisson (C)
Pierre Olivier Bonnin (PO)
Mohamed Dhaouadi (M)
Ghislaine Gardes (G)
Mikael Perin (M)
Sophie Brunet (S)
Yann Gricourt (Y)
Marc-Olivier Fischer (MO)
Stéphane Debroczi (S)
Lucie Retournay (L)
Pierre Strub (P)
Patrice Vivin (P)
Rachel Dupays (R)
Thomas Kerforne (T)
Gabriel Vianet (G)
Virginie Manzano (V)
Eric Noll (E)
Pierre-Olivier Ludes (PO)
Thien-Nga Chamaraux-Tran (TN)
Cédric Cirenei (C)
Djihad Hamroun (D)
Benoit Lebas (B)
Grégoire Andrieu Andrieu (GA)
Vincent Etienne (V)
Raphaël Cinotti (R)
Natacha Simon (N)
Denis Frasca (D)
Hélène Beloeil (H)
Amandine LE Gall (A)
Petyo Techev (P)
Ludovic Meuret (L)
Jérémie Joffre (J)
Hervé Dupont (H)
Beny Charbit (B)
Arthur Davy (A)
David Lobo (D)
Jean-Michel Devys (JM)
Benjamin Soria (B)
Clémentine Cholet (C)
Cyrus Motamed (C)
Anne Wyniecki (A)
Valérie Billard (V)
Migena Demiri (M)
Clement Millet (C)
Samuel Degoul (S)
Christophe Canevet (C)
Céline Mounier (C)
Flavie Desrumaux (F)
Julia Martinez (J)
Claire Texier (C)
Benoit Voisin (B)
Guillaume Dubreuil (G)
Jacques DE Montblanc (J)
Claire Mengelle (C)
Laura Ruscio (L)
Emmanuel Futier (E)
Julie Fayon (J)
Benoit Baietto (B)
Marie Vignaud (M)
Yoann Munier (Y)
Bertille Paquette (B)
Diana Saptefrat (D)
Zakia Machroub (Z)
Jean-Sébastien Aubert (JS)
Georges Abi Abdallah (G)
Nicolas Polge (N)
Najla Dachraoui (N)
Anne Godier (A)
Diane Zlotnik (D)
Hélène Nougue (H)
Darless Clausse (D)
Sabrina Ma (S)
Sherifatou Salami-Adjavon (S)
Patrick Rossignol (P)
Francis Berthier (F)
Romain Barthélémy (R)
Gabriel Vianet (G)
Damien Logeart (D)
Peggy Reiner (P)
Karine Pautrat (K)
Alex Hong (A)
Marine Coroir (M)
Claire Mayeur (C)
Jacques Thes (J)
Florent Laverdure (F)
Sofiane Seri (S)
Violeta Bercan (V)
Cristian Radu Ionescu (CR)
Caroline Gonnet Pinton (C)
Marc Leone (M)
Nathalie Lesavre (N)
Jeanne Chatelon (J)
Marion Poirier (M)
Adrien Rivory (A)
Stéphanie Roullet (S)
Sean Coeckelenbergh (S)
Leila Toubal (L)
Joanna Ramadan (J)
Karine Nouette-Gaulain (K)
Bruno Ralec (B)
Chloé Thill (C)
Christophe Giacardi (C)
Etienne Montelescaut (E)
Philippe Aries (P)
Benoît Tavernier (B)
Julie Bellet (J)
Romain Delassus (R)
Hélène Tribouillard (H)
Daniel Verzilli (D)
Alice Millot (A)
Audrey DE Jong (A)
Marie Geniez (M)
Virginie Marre (V)
Michaëla Penne (M)
Yvan Pouzeratte (Y)
Guillaume Rao (G)
Maxime Coutrot (M)
Alice Blet (A)
Benoit Plaud (B)
Emmanuel Basto (E)
Mathilde Ponsin (M)
Marie-Christine Becq (MC)
Maïté Chaussard (M)
Aristide Ntahe (A)
François Depret (F)
Lucie Guillemet (L)
Arnaud Valent (A)
Lyse Flores (L)
Julien Burey (J)
Sarah Feray (S)
Yoann Elmaleh (Y)
Sophie Dupeyrat (S)
Thomas Baury (T)
Clémentine Taconet (C)
Thomas Rimmele (T)
Elodie Mazocky (E)
Marie Luce Parrouffe (ML)
Catherine Jadaud (C)
Stanislas Abrard (S)
Pierre-Antoine Tronche (PA)
Arthur Vial (A)
Emma Aka (E)
Anne-Sophie Bellocq (AS)
Jean-François Carabalona (JF)
Blandine Fayard (B)
Jean Marie Guyader (JM)
Letitia Huriaux (L)
Ingrid Millot (I)
Antoine Lamblin (A)
Marine Dutour (M)
Mathilde Roukhomovsky-Moretti (M)
Pascal Meuret (P)
Nadir Omrani (N)
Barnabé Raymond (B)
Clemence Roy (C)
Florent Sigwalt (F)
Xavier Merindol (X)
Mathieu Desmard (M)
Louis Bourreau (L)
Pierre-Antoine Allain (PA)
Charlotte Dei Svaldi (C)
Brenton Alexander (B)

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Auteurs

Matthieu Legrand (M)

Department of Anesthesiology and Perioperative Care, Division of Critical Care Medicine, University of California, San Francisco.
French Clinical Research Infrastructure Network Initiative-Cardio Renal Clinical Trialists Network, Nancy, France.

Jérémy Falcone (J)

Centre Hospitalier Universitaire de Lille, Hôpital Huriez, Lille, France.

Bernard Cholley (B)

Department of Anesthesiology and Intensive Care, Hôpital Européen Georges Pompidou, AP-HP, Paris, France.

Hélène Charbonneau (H)

Department of Anesthesiology and Intensive Care Unit, Clinique Pasteur, Toulouse, France.

Amélie Delaporte (A)

Hôpital Marie Lannelongue, Le Plessis-Robinson, France.

Adrien Lemoine (A)

Service d'Anesthésie-Réanimation et Médecine Péri-Opératoire, Hôpital Tenon, APHP, Sorbonne Université, Paris, France.

Matthias Garot (M)

Centre Hospitalier Universitaire de Lille, Hôpital Huriez, Lille, France.

Alexandre Joosten (A)

Department of Anesthesiology and Perioperative Medicine, David Geffen School of Medicine, University of California, Los Angeles.

Claude Meistelman (C)

Department of Anesthesiology, CHU de Nancy Brabois and Hopital Saint Charles, Saint Dié des Vosges, France.

Delphine Cheron-Leroy (D)

Université Paris Cité, AP-HP, Hôpital Saint-Louis, DMU PARABOL, Service d'Anesthésie-Réanimation-Centre de Traitment des Brûlés, Paris, France.

Jean-Philippe Rives (JP)

Service d'Anesthésie, Département d'Anesthésie, de Chirurgie et Interventionnel, Hôpital Gustave Roussy, Villejuif, France.

Bruno Pastene (B)

Aix Marseille Université, APHM, Service d'Anesthésie et de Réanimation, Hôpital Nord, Marseille, France.

Antoine Dewitte (A)

Service d'Anesthésie-Réanimation, Centre Hospitalier Universitaire de Bordeaux, Pessac, France.
Université de Bordeaux, CNRS, Inserm, Immuno ConcEpT, UMR 5164, Bordeaux, France.

Stéphanie Sigaut (S)

Department of Anesthesiology and Intensive Care, AP-HP, Hôpital Beaujon, Clichy, France.

Marc Danguy des Deserts (M)

Department of Anesthesia and Intensive Care, Clermont-Tonnerre Military Hospital, Univ Brest, Inserm, UMR 1304-GETBO, Brest, France.

Cyrille Truc (C)

Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.

Matthieu Boisson (M)

Université de Poitiers, INSERM U1070 PHAR2, CHU de Poitiers, Service d'Anesthésie-Réanimation et Médecine Péri-Opératoire, Poitiers, France.

Sigismond Lasocki (S)

Département Anesthésie Réanimation, CHU d'Angers, Angers, France.

Philippe Cuvillon (P)

Département Anesthésie, Centre Hospitalier Universitaire Caremeau, Nîmes et Université Montpellier 1, Montpellier, France.

Ugo Schiff (U)

Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing, Clermont Ferrand, France.

Samir Jaber (S)

Anesthesia and Critical Care Department, Saint Eloi, University of Montpellier, Research Unit: PhyMedExp, INSERM U-1046, CNRS, Montpellier, France.

Morgan Le Guen (M)

Hôpital Foch, Suresnes, France.

Anaïs Caillard (A)

Département Anesthésie Réanimation, Centre Hospitalier Universitaire Brest, Brest, France.

Stéphane Bar (S)

Department of Anaesthesiology and Critical Care Medicine, Amiens University Hospital, Rond-Point du Professeur Christian Cabrol, Amiens, France.

Edmundo Pereira de Souza Neto (E)

Centre Hospitalier de Montauban, Montauban, France.

Vincent Colas (V)

Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille, Lille, France.

Florin Dimache (F)

Centre Hospitalier Universitaire de Strasbourg, Strasbourg, France.

Thibaut Girardot (T)

Centre Hospitalier de Valence, Valence, France.

Elsa Jozefowicz (E)

Departement d'Anesthesie-Reanimation, Centre Hospitalier Universitaire de Lille, Hôpital Roger Salengro, Lille, France.

Simon Viquesnel (S)

Anesthesia and Intensive Care Department, Université de Rennes, CHU Rennes, Rennes, France.

Francis Berthier (F)

Département d'Anesthésie Réanimation Chirurgicale, Université de Franche-Comté, Centre Hospitalier Universitaire Besançon, INSERM CIC 1431, SINERGIES, Besançon, France.

Eric Vicaut (E)

Unité de Recherche Clinique, GH St-Louis-Lariboisère-Fernand Widal, Université Paris Diderot, Paris, France.

Etienne Gayat (E)

French Clinical Research Infrastructure Network Initiative-Cardio Renal Clinical Trialists Network, Nancy, France.
Université Paris Cité, AP-HP, Hôpital Lariboisière, DMU PARABOL, Service d'Anesthésie-Réanimation-CTB, Paris, France.
Inserm U942 MASCOT, Paris, France.

Classifications MeSH