Continuation vs Discontinuation of Renin-Angiotensin System Inhibitors Before Major Noncardiac Surgery
Author:
Legrand Matthieu12, Falcone Jérémy3, Cholley Bernard4, Charbonneau Hélène5, Delaporte Amélie6, Lemoine Adrien7, Garot Matthias3, Joosten Alexandre8, Meistelman Claude9, Cheron-Leroy Delphine10, Rives Jean-Philippe11, Pastene Bruno12, Dewitte Antoine1314, Sigaut Stéphanie15, Danguy des Deserts Marc16, Truc Cyrille17, Boisson Matthieu18, Lasocki Sigismond19, Cuvillon Philippe20, Schiff Ugo21, Jaber Samir22, Le Guen Morgan23, Caillard Anaïs24, Bar Stéphane25, Pereira de Souza Neto Edmundo26, Colas Vincent27, Dimache Florin28, Girardot Thibaut29, Jozefowicz Elsa30, Viquesnel Simon31, Berthier Francis32, Vicaut Eric33, Gayat Etienne23435, , MONZIOLS Simon36, DEFAYE Mylene36, CAMUS Thibault36, ROBIN Jean-Jacques36, OUATTARA Alexandre36, FETITA Ioana36, JOANNES-BOYAU Olivier36, BONNARDEL Eline36, BOUQUEREL Rémi36, STRZELECKI Antoine36, FAYON Thibaut36, PELLETIER Christophe36, LE GAILLARD Benjamin36, GIRARDOT Thibaut36, AMOUSSOU Géraud36, EL BOUYOUSFI Maalik36, GANASCIA Bruno36, BUTRULLE Calliope36, GERGAUD Soizic36, HABRIAL Pierre36, PESSIOT Solène36, SAMSON Emmanuel36, WOLFF Caroline36, STANKOVA Nevena36, AOUATI Farida36, KAVAFYAN Juliette36, SUPARSCHI Vlad36, LONGROIS Dan36, LE ROY Julie36, ROSSIGNOL Benoit36, HUET Olivier36, BOISSON Christophe36, BONNIN Pierre Olivier36, DHAOUADI Mohamed36, GARDES Ghislaine36, PERIN Mikael36, BRUNET Sophie36, GRICOURT Yann36, FISCHER Marc-Olivier36, DEBROCZI Stéphane36, RETOURNAY Lucie36, STRUB Pierre36, VIVIN Patrice36, DUPAYS Rachel36, KERFORNE Thomas36, VIANET Gabriel36, MANZANO Virginie36, NOLL Eric36, LUDES Pierre-Olivier36, CHAMARAUX-TRAN Thien-Nga36, CIRENEI Cédric36, HAMROUN Djihad36, LEBAS Benoit36, ANDRIEU Grégoire ANDRIEU36, ETIENNE Vincent36, CINOTTI Raphaël36, SIMON Natacha36, FRASCA Denis36, BELOEIL Hélène36, LE GALL Amandine36, TECHEV Petyo36, MEURET Ludovic36, JOFFRE Jérémie36, DUPONT Hervé36, CHARBIT Beny36, DAVY Arthur36, LOBO David36, DEVYS Jean-Michel36, SORIA Benjamin36, CHOLET Clémentine36, MOTAMED Cyrus36, WYNIECKI Anne36, BILLARD Valérie36, DEMIRI Migena36, MILLET Clement36, DEGOUL Samuel36, CANEVET Christophe36, MOUNIER Céline36, DESRUMAUX Flavie36, MARTINEZ Julia36, TEXIER Claire36, VOISIN Benoit36, DUBREUIL Guillaume36, DE MONTBLANC Jacques36, MENGELLE Claire36, RUSCIO Laura36, FUTIER Emmanuel36, FAYON JULIE36, BAIETTO Benoit36, VIGNAUD Marie36, MUNIER Yoann36, PAQUETTE Bertille36, SAPTEFRAT Diana36, MACHROUB Zakia36, AUBERT Jean-Sébastien36, ABI ABDALLAH Georges36, POLGE Nicolas36, DACHRAOUI Najla36, GODIER Anne36, ZLOTNIK Diane36, NOUGUE Hélène36, CLAUSSE Darless36, MA Sabrina36, SALAMI-ADJAVON Sherifatou36, ROSSIGNOL Patrick36, BERTHIER Francis36, BARTHÉLÉMY Romain36, VIANET gabriel36, LOGEART Damien36, REINER Peggy36, PAUTRAT Karine36, HONG Alex36, COROIR Marine36, MAYEUR Claire36, THES Jacques36, LAVERDURE Florent36, SERI Sofiane36, BERCAN Violeta36, IONESCU Cristian Radu36, GONNET PINTON Caroline36, LEONE Marc36, LESAVRE Nathalie36, CHATELON Jeanne36, POIRIER Marion36, RIVORY Adrien36, ROULLET Stéphanie36, COECKELENBERGH Sean36, TOUBAL Leila36, RAMADAN Joanna36, NOUETTE-GAULAIN Karine36, RALEC Bruno36, THILL Chloé36, GIACARDI Christophe36, MONTELESCAUT Etienne36, ARIES Philippe36, TAVERNIER Benoît36, BELLET Julie36, DELASSUS Romain36, TRIBOUILLARD Hélène36, VERZILLI Daniel36, MILLOT Alice36, DE JONG Audrey36, GENIEZ Marie36, MARRE Virginie36, PENNE Michaëla36, POUZERATTE Yvan36, RAO Guillaume36, COUTROT Maxime36, BLET Alice36, PLAUD Benoit36, BASTO Emmanuel36, PONSIN Mathilde36, BECQ Marie-Christine36, CHAUSSARD Maïté36, NTAHE Aristide36, DEPRET François36, GUILLEMET Lucie36, VALENT Arnaud36, FLORES Lyse36, BUREY Julien36, FERAY Sarah36, ELMALEH Yoann36, DUPEYRAT Sophie36, BAURY Thomas36, TACONET Clémentine36, RIMMELE Thomas36, MAZOCKY Elodie36, PARROUFFE Marie Luce36, JADAUD Catherine36, ABRARD Stanislas36, TRONCHE Pierre-Antoine36, VIAL Arthur36, AKA Emma36, BELLOCQ Anne-Sophie36, CARABALONA Jean-François36, FAYARD Blandine36, GUYADER Jean Marie36, HURIAUX Letitia36, MILLOT Ingrid36, LAMBLIN Antoine36, DUTOUR Marine36, ROUKHOMOVSKY-MORETTI Mathilde36, MEURET Pascal36, OMRANI Nadir36, RAYMOND Barnabé36, ROY Clemence 36, SIGWALT Florent36, MERINDOL Xavier36, DESMARD Mathieu36, BOURREAU Louis36, ALLAIN Pierre-Antoine36, DEI SVALDI Charlotte36, ALEXANDER Brenton36
Affiliation:
1. Department of Anesthesiology and Perioperative Care, Division of Critical Care Medicine, University of California, San Francisco 2. French Clinical Research Infrastructure Network Initiative–Cardio Renal Clinical Trialists Network, Nancy, France 3. Centre Hospitalier Universitaire de Lille, Hôpital Huriez, Lille, France 4. Department of Anesthesiology and Intensive Care, Hôpital Européen Georges Pompidou, AP-HP, Paris, France 5. Department of Anesthesiology and Intensive Care Unit, Clinique Pasteur, Toulouse, France 6. Hôpital Marie Lannelongue, Le Plessis-Robinson, France 7. Service d’Anesthésie–Réanimation et Médecine Péri-Opératoire, Hôpital Tenon, APHP, Sorbonne Université, Paris, France 8. Department of Anesthesiology and Perioperative Medicine, David Geffen School of Medicine, University of California, Los Angeles 9. Department of Anesthesiology, CHU de Nancy Brabois and Hopital Saint Charles, Saint Dié des Vosges, France 10. Université Paris Cité, AP-HP, Hôpital Saint-Louis, DMU PARABOL, Service d’Anesthésie-Réanimation-Centre de Traitment des Brûlés, Paris, France 11. Service d’Anesthésie, Département d’Anesthésie, de Chirurgie et Interventionnel, Hôpital Gustave Roussy, Villejuif, France 12. Aix Marseille Université, APHM, Service d’Anesthésie et de Réanimation, Hôpital Nord, Marseille, France 13. Service d’Anesthésie-Réanimation, Centre Hospitalier Universitaire de Bordeaux, Pessac, France 14. Université de Bordeaux, CNRS, Inserm, Immuno ConcEpT, UMR 5164, Bordeaux, France 15. Department of Anesthesiology and Intensive Care, AP-HP, Hôpital Beaujon, Clichy, France 16. Department of Anesthesia and Intensive Care, Clermont-Tonnerre Military Hospital, Univ Brest, Inserm, UMR 1304-GETBO, Brest, France 17. Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France 18. Université de Poitiers, INSERM U1070 PHAR2, CHU de Poitiers, Service d’Anesthésie-Réanimation et Médecine Péri-Opératoire, Poitiers, France 19. Département Anesthésie Réanimation, CHU d’Angers, Angers, France 20. Département Anesthésie, Centre Hospitalier Universitaire Caremeau, Nîmes et Université Montpellier 1, Montpellier, France 21. Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing, Clermont Ferrand, France 22. Anesthesia and Critical Care Department, Saint Eloi, University of Montpellier, Research Unit: PhyMedExp, INSERM U-1046, CNRS, Montpellier, France 23. Hôpital Foch, Suresnes, France 24. Département Anesthésie Réanimation, Centre Hospitalier Universitaire Brest, Brest, France 25. Department of Anaesthesiology and Critical Care Medicine, Amiens University Hospital, Rond-Point du Professeur Christian Cabrol, Amiens, France 26. Centre Hospitalier de Montauban, Montauban, France 27. Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille, Lille, France 28. Centre Hospitalier Universitaire de Strasbourg, Strasbourg, France 29. Centre Hospitalier de Valence, Valence, France 30. Departement d’Anesthesie-Reanimation, Centre Hospitalier Universitaire de Lille, Hôpital Roger Salengro, Lille, France 31. Anesthesia and Intensive Care Department, Université de Rennes, CHU Rennes, Rennes, France 32. Département d’Anesthésie Réanimation Chirurgicale, Université de Franche-Comté, Centre Hospitalier Universitaire Besançon, INSERM CIC 1431, SINERGIES, Besançon, France 33. Unité de Recherche Clinique, GH St-Louis-Lariboisère-Fernand Widal, Université Paris Diderot, Paris, France 34. Université Paris Cité, AP-HP, Hôpital Lariboisière, DMU PARABOL, Service d’Anesthésie-Réanimation-CTB, Paris, France 35. Inserm U942 MASCOT, Paris, France 36. for the Stop-or-Not Trial Group
Abstract
ImportanceBefore 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.ObjectiveTo evaluate whether a continuation strategy vs a discontinuation strategy of RASIs before major noncardiac surgery results in decreased complications at 28 days after surgery.Design, Setting, and ParticipantsRandomized 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.InterventionPatients 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).Main Outcomes and MeasuresThe 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.ResultsOf 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.Conclusions and RelevanceAmong 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.Trial RegistrationClinicalTrials.gov Identifier: NCT03374449
Publisher
American Medical Association (AMA)
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