Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery : An International Randomized Controlled Trial.


Journal

Annals of internal medicine
ISSN: 1539-3704
Titre abrégé: Ann Intern Med
Pays: United States
ID NLM: 0372351

Informations de publication

Date de publication:
05 2023
Historique:
medline: 17 5 2023
pubmed: 24 4 2023
entrez: 24 04 2023
Statut: ppublish

Résumé

Among patients having noncardiac surgery, perioperative hemodynamic abnormalities are associated with vascular complications. Uncertainty remains about what intraoperative blood pressure to target and how to manage long-term antihypertensive medications perioperatively. To compare the effects of a hypotension-avoidance and a hypertension-avoidance strategy on major vascular complications after noncardiac surgery. Partial factorial randomized trial of 2 perioperative blood pressure management strategies (reported here) and tranexamic acid versus placebo. (ClinicalTrials.gov: NCT03505723). 110 hospitals in 22 countries. 7490 patients having noncardiac surgery who were at risk for vascular complications and were receiving 1 or more long-term antihypertensive medications. In the hypotension-avoidance strategy group, the intraoperative mean arterial pressure target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld and the other long-term antihypertensive medications were administered only for systolic blood pressures 130 mm Hg or greater, following an algorithm. In the hypertension-avoidance strategy group, the intraoperative mean arterial pressure target was 60 mm Hg or greater; all antihypertensive medications were continued before and after surgery. The primary outcome was a composite of vascular death and nonfatal myocardial injury after noncardiac surgery, stroke, and cardiac arrest at 30 days. Outcome adjudicators were masked to treatment assignment. The primary outcome occurred in 520 of 3742 patients (13.9%) in the hypotension-avoidance group and in 524 of 3748 patients (14.0%) in the hypertension-avoidance group (hazard ratio, 0.99 [95% CI, 0.88 to 1.12]; Adherence to the assigned strategies was suboptimal; however, results were consistent across different adherence levels. In patients having noncardiac surgery, our hypotension-avoidance and hypertension-avoidance strategies resulted in a similar incidence of major vascular complications. Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong.

Sections du résumé

BACKGROUND
Among patients having noncardiac surgery, perioperative hemodynamic abnormalities are associated with vascular complications. Uncertainty remains about what intraoperative blood pressure to target and how to manage long-term antihypertensive medications perioperatively.
OBJECTIVE
To compare the effects of a hypotension-avoidance and a hypertension-avoidance strategy on major vascular complications after noncardiac surgery.
DESIGN
Partial factorial randomized trial of 2 perioperative blood pressure management strategies (reported here) and tranexamic acid versus placebo. (ClinicalTrials.gov: NCT03505723).
SETTING
110 hospitals in 22 countries.
PATIENTS
7490 patients having noncardiac surgery who were at risk for vascular complications and were receiving 1 or more long-term antihypertensive medications.
INTERVENTION
In the hypotension-avoidance strategy group, the intraoperative mean arterial pressure target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld and the other long-term antihypertensive medications were administered only for systolic blood pressures 130 mm Hg or greater, following an algorithm. In the hypertension-avoidance strategy group, the intraoperative mean arterial pressure target was 60 mm Hg or greater; all antihypertensive medications were continued before and after surgery.
MEASUREMENTS
The primary outcome was a composite of vascular death and nonfatal myocardial injury after noncardiac surgery, stroke, and cardiac arrest at 30 days. Outcome adjudicators were masked to treatment assignment.
RESULTS
The primary outcome occurred in 520 of 3742 patients (13.9%) in the hypotension-avoidance group and in 524 of 3748 patients (14.0%) in the hypertension-avoidance group (hazard ratio, 0.99 [95% CI, 0.88 to 1.12];
LIMITATION
Adherence to the assigned strategies was suboptimal; however, results were consistent across different adherence levels.
CONCLUSION
In patients having noncardiac surgery, our hypotension-avoidance and hypertension-avoidance strategies resulted in a similar incidence of major vascular complications.
PRIMARY FUNDING SOURCE
Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong.

Identifiants

pubmed: 37094336
doi: 10.7326/M22-3157
doi:

Substances chimiques

Antihypertensive Agents 0

Banques de données

ClinicalTrials.gov
['NCT03505723']

Types de publication

Randomized Controlled Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

605-614

Subventions

Organisme : CIHR
Pays : Canada

Investigateurs

Maura Marcucci (M)
Thomas W Painter (TW)
David Conen (D)
Vladimir Lomivorotov (V)
Daniel I Sessler (DI)
Matthew T V Chan (MTV)
Flavia K Borges (FK)
Kate Leslie (K)
Emmanuelle Duceppe (E)
María José Martínez-Zapata (MJ)
Chew Yin Wang (CY)
Denis Xavier (D)
Sandra N Ofori (SN)
Michael Ke Wang (MK)
Sergey Efremov (S)
Giovanni Landoni (G)
Ydo V Kleinlugtenbelt (YV)
Wojciech Szczeklik (W)
Denis Schmartz (D)
Timothy G Short (TG)
Maria Wittmann (M)
Christian S Meyhoff (CS)
Mohammed Amir (M)
David Torres (D)
Ameen Patel (A)
Kurt Ruetzler (K)
Joel L Parlow (JL)
Vikas Tandon (V)
Carisi A Polanczyk (CA)
Raja Jayaram (R)
Sergey V Astrakov (SV)
Sabry Ayad (S)
Mikhail Kirov (M)
Miriam de Nadal (M)
Pilar Paniagua (P)
Hector J Aguado (HJ)
Kamal Maheshwari (K)
Michael H McGillion (MH)
Jessica Vincent (J)
Ingrid Copland (I)
Kumar Balasubramanian (K)
Sadeesh Srinathan (S)
David Stillo (D)
Andrea Kurz (A)
Emilie P Belley-Côté (EP)
Jessica Spence (J)
Shrikant I Bangdiwala (SI)
Gordon Guyatt (G)
Salim Yusuf (S)
P J Devereaux (PJ)
Toby Richards (T)
John Eikelboom (J)
Chaoran Wu (C)
Peter Gross (P)
Pavel Roshanov (P)
Ian Roberts (I)
Dean Fergusson (D)
Pierre Foëx (P)
Finlay McAlister (F)
Sara Di Diodato (S)
Rosemary Howe (R)
Hannah MacDonald (H)
Louise Mastrangelo (L)
Clare McGall (C)
Natalie Mercuri (N)
Sarah Molnar (S)
Trisha Southall (T)
Jennifer Swanson (J)
Makayla Tosh (M)
Eric Deng (E)
Tamara Marsden (T)
Mark Molec (M)
Olga Shestakovska (O)
Robin Zhao (R)
Mikhail Ya Yadgarov (MY)
Dmitry B Borisov (DB)
John Gorman (J)
Teresa Cafaro (T)
Stefano Italiano (S)
Andrés Valenzuela Suárez (AV)
Steffen Blum (S)
Nuria Ruiz-López (N)
Christian E Haarmark Nielsen (CE)
Anna Włudarczyk (A)
Federico Germini (F)
Javiera Paz Vasquez (JP)
L J Bleijerveen (LJ)
Stefan Schandelmaier (S)
Jesse Popov (J)
Daniel Moller (D)
Carlos Moliner Abós (C)
Denis Losik (D)
Arnav Agarwal (A)
Chantal Mulkens (C)
Elizaveta Fisher (E)
Pawel Wrona (P)
Martin Sramek (M)
Steffan F Stella (SF)
Antonia Nucera (A)
Franziska Kuestermann (F)
Emmanuel Egom (E)
Shaan Gupta (S)
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Simon Macklin (S)
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Luz Divina Arazo (LD)
Andres Giraldo (A)
Steven Minear (S)
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Joshua D Pasek (JD)
Jaume Borrell-Vega (J)
Caitlin Hatten (C)
Olufunke Dada (O)
Johnny McKeown (J)
Juan Fiorda-Diaz (J)
Marco Echeverria-Villalobos (M)
Michael Essandoh (M)
Priya A Kumar (PA)
Harendra Arora (H)
Meena Bhatia (M)
Scott Alan Miller (SA)
Bruce Cusson (B)
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Vincent Pinkert (V)
Shamsuddin Akhtar (S)
Miriam Treggiari (M)
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Commentaires et corrections

Type : CommentIn

Auteurs

Maura Marcucci (M)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Thomas W Painter (TW)

Acute Care Medicine, University of Adelaide, Adelaide, South Australia, Australia (T.W.P.).

David Conen (D)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Vladimir Lomivorotov (V)

Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Centre, Novosibirsk, Russia (V.L., S.I.).

Daniel I Sessler (DI)

Anesthesiology Institute, Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.I.S., K.R., S.A., K.M., A.K.).

Matthew T V Chan (MTV)

The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China (M.T.V.C., W.K.K.W.).

Flavia K Borges (FK)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Kate Leslie (K)

Department of Critical Care Medicine, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia (K.L.).

Emmanuelle Duceppe (E)

Department of Medicine, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada (E.D.).

María José Martínez-Zapata (MJ)

Iberoamerican Cochrane Centre, Public Health and Clinical Epidemiology Service, IIB Sant Pau, CIBERESP, Barcelona, Spain (M.J.M.).

Chew Yin Wang (CY)

Department of Anesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia (C.Y.W., C.C.C.).

Denis Xavier (D)

St. John's Medical College, Bangalore, India (D.X.).

Sandra N Ofori (SN)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Michael Ke Wang (MK)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Sergey Efremov (S)

Saint Petersburg State University Hospital, Saint Petersburg, Russia (S.E.).

Giovanni Landoni (G)

Department of Anesthesiology and Intensive Care, IRCCS San Raffaele Scientific Institute, Vita Salute San Raffaele University, Milan, Italy (G.L.).

Ydo V Kleinlugtenbelt (YV)

Department of Orthopedic and Trauma Surgery, Deventer Ziekenhuis, Deventer, the Netherlands (Y.V.K.).

Wojciech Szczeklik (W)

Centre for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Krakow, Poland (W.S.).

Denis Schmartz (D)

CHU Brugmann, Université Libre de Bruxelles, Brussels, Belgium (D.S.).

Amit X Garg (AX)

Department of Medicine, Western University, London, Ontario, Canada (A.X.G.).

Timothy G Short (TG)

Department of Anaesthesia, Auckland City Hospital, Auckland, New Zealand (T.G.S.).

Maria Wittmann (M)

Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn, Bonn, Germany (M.W.).

Christian S Meyhoff (CS)

Department of Anesthesia and Intensive Care, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark (C.S.M.).

Mohammed Amir (M)

Department of Surgery, Shifa International Hospital and Shifa Tameer-e-Millat University, Islamabad, Pakistan (M.A.).

David Torres (D)

Departamento de Epidemiología y Estudios en Salud, Universidad de Los Andes, Santiago, Chile (D.T.).

Ameen Patel (A)

Department of Medicine, McMaster University, Hamilton, Ontario, Canada (A.P., V.T.).

Kurt Ruetzler (K)

Anesthesiology Institute, Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.I.S., K.R., S.A., K.M., A.K.).

Joel L Parlow (JL)

Department of Anesthesiology and Perioperative Medicine, Queen's University, and Kingston Health Sciences Centre, Kingston, Ontario, Canada (J.L.P.).

Vikas Tandon (V)

Department of Medicine, McMaster University, Hamilton, Ontario, Canada (A.P., V.T.).

Edith Fleischmann (E)

Department of Anesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria (E.F.).

Carisi A Polanczyk (CA)

UFRGS, Hospital de Clínicas de Porto Alegre, National Institute for Health Technology Assessment, IATS; Hospital Moinhos de Vento, Porto Alegre, Brazil (C.A.P.).

Andre Lamy (A)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Raja Jayaram (R)

Department of Anaesthetics, Clinical Neurosciences, University of Oxford, Oxford University Hospitals NHS Trust, Oxford, United Kingdom (R.J.).

Sergey V Astrakov (SV)

Department of Anesthesiology, Novosibirsk State University, Novosibirsk, Russia (S.V.A.).

William Ka Kei Wu (WKK)

The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China (M.T.V.C., W.K.K.W.).

Chao Chia Cheong (CC)

Department of Anesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia (C.Y.W., C.C.C.).

Sabry Ayad (S)

Anesthesiology Institute, Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.I.S., K.R., S.A., K.M., A.K.).

Mikhail Kirov (M)

Department of Anesthesiology and Intensive Care Medicine, Northern State Medical University, Arkhangelsk, Russia (M.K.).

Miriam de Nadal (M)

Department of Anesthesiology and Intensive Care, Hospital Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain (M. de N.).

Valery V Likhvantsev (VV)

V. Negovsky Reanimatology Research Institute, Moscow, Russia (V.V.L.).

Pilar Paniagua (P)

Anesthesiology Department, Santa Creu i Sant Pau University Hospital, Barcelona, Spain (P.P.).

Hector J Aguado (HJ)

Trauma & Orthopaedic Surgery Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain (H.J.A.).

Kamal Maheshwari (K)

Anesthesiology Institute, Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.I.S., K.R., S.A., K.M., A.K.).

Richard P Whitlock (RP)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Michael H McGillion (MH)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Jessica Vincent (J)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Ingrid Copland (I)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Kumar Balasubramanian (K)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Bruce M Biccard (BM)

Department of Anesthesia and Perioperative Medicine, Groote Schuur Hospital, and University of Cape Town, Cape Town, South Africa (B.M.B.).

Sadeesh Srinathan (S)

Section of Thoracic Surgery, Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada (S.S.).

Samandar Ismoilov (S)

Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Centre, Novosibirsk, Russia (V.L., S.I.).

Shirley Pettit (S)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

David Stillo (D)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Andrea Kurz (A)

Anesthesiology Institute, Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.I.S., K.R., S.A., K.M., A.K.).

Emilie P Belley-Côté (EP)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Jessica Spence (J)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

William F McIntyre (WF)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Shrikant I Bangdiwala (SI)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

Gordon Guyatt (G)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada (G.G.).

Salim Yusuf (S)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

P J Devereaux (PJ)

Population Health Research Institute, Hamilton, Ontario, Canada (M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., I.C., K.B., S.P., D.S., E.P.B., J.S., W.F.M., S.I.B., S.Y., P.J.D.).

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