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

Maura Marcucci; Thomas W Painter; POISE-3 Trial Investigators and Study Groups; David Conen; Vladimir Lomivorotov; Daniel I Sessler; Matthew T V Chan; Flavia K Borges; Kate Leslie; Emmanuelle Duceppe; María José Martínez-Zapata; Chew Yin Wang; Denis Xavier; Sandra N Ofori; Michael Ke Wang; Sergey Efremov; Giovanni Landoni; Ydo V Kleinlugtenbelt; Wojciech Szczeklik; Denis Schmartz; Amit X Garg; Timothy G Short; Maria Wittmann; Christian S Meyhoff; Mohammed Amir; David Torres; Ameen Patel; Kurt Ruetzler; Joel L Parlow; Vikas Tandon; Edith Fleischmann; Carisi A Polanczyk; Andre Lamy; Raja Jayaram; Sergey V Astrakov; William Ka Kei Wu; Chao Chia Cheong; Sabry Ayad; Mikhail Kirov; Miriam de Nadal; Valery V Likhvantsev; Pilar Paniagua; Hector J Aguado; Kamal Maheshwari; Richard P Whitlock; Michael H McGillion; Jessica Vincent; Ingrid Copland; Kumar Balasubramanian; Bruce M Biccard; Sadeesh Srinathan; Felix van Lier

doi:10.7326/M22-3157

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

Maura Marcucci
, Thomas W Painter
, POISE-3 Trial Investigators and Study Groups
, David Conen
, Vladimir Lomivorotov
, Daniel I Sessler
, Matthew T V Chan
, Flavia K Borges
, Kate Leslie
, Emmanuelle Duceppe
, María José Martínez-Zapata
, Chew Yin Wang
, Denis Xavier
, Sandra N Ofori
, Michael Ke Wang
, Sergey Efremov
, Giovanni Landoni
, Ydo V Kleinlugtenbelt
, Wojciech Szczeklik
, Denis Schmartz

Amit X Garg, Timothy G Short, Maria Wittmann, Christian S Meyhoff, Mohammed Amir, David Torres, Ameen Patel, Kurt Ruetzler, Joel L Parlow, Vikas Tandon, Edith Fleischmann, Carisi A Polanczyk, Andre Lamy, Raja Jayaram, Sergey V Astrakov, William Ka Kei Wu, Chao Chia Cheong, Sabry Ayad, Mikhail Kirov, Miriam de Nadal, Valery V Likhvantsev, Pilar Paniagua, Hector J Aguado, Kamal Maheshwari, Richard P Whitlock, Michael H McGillion, Jessica Vincent, Ingrid Copland, Kumar Balasubramanian, Bruce M Biccard, Sadeesh Srinathan, Felix van Lier

Anesthesiology

Population Health Research Institute (Hamilton)
Royal Adelaide Hospital and University of Adelaide
Department of Anesthesiology and Intensive Care Medicine
Anesthesiology Institute
Chinese University of Hong Kong
The University of Melbourne and Melbourne Health
Centre Hospitalier de l'Université de Montréal
Iberoamerican Cochrane Centre
University of Malaya
St. John's Medical College Hospital
Saint Petersburg State University Hospital
Vita-Salute San Raffaele University Milan
Department of Orthopedic and Trauma Surgery
Jagiellonian University Medical College
CHU Brugmann
Western University
Auckland City Hospital
University Hospital Bonn
Bispebjerg and Frederiksberg University Hospitals
Shifa International Hospital and Shifa Tameer-e-Millat University
Departamento de Epidemiología y Estudios en Salud
McMaster University
Queen's University Belfast
Medical University of Vienna
Institute for Health Technology Assessment (IATS/CNPq)
University of Oxford
Novosibirsk State Technical University
Northern State Medical University
Vall d'Hebron Institute of Oncology
V. Negovsky Reanimatology Research Institute
Santa Creu i Sant Pau University Hospital
Hospital Clínico Universitario de Valladolid
University of Cape Town
University of Manitoba and Biology of Breathing Theme

Research output: Contribution to journal › Article › Academic › peer-review

155 Citations (Scopus)

Abstract

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]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term.

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.

Original language	English
Pages (from-to)	605-614
Number of pages	10
Journal	Annals of Internal Medicine
Volume	176
Issue number	5
DOIs	https://doi.org/10.7326/M22-3157
Publication status	Published - 1 May 2023

Bibliographical note

Funding Information:
Financial Support: By Canadian Institutes of Health Research Foundation Grant awarded to Dr. Devereaux (FDN-143302); National Health and Medical Research Council, Funding Schemes, NHMRC Project Grant 1162362; and General Research Fund 14104419, Research Grant Council, Hong Kong SAR, China. POISE-3 also received financial support from the Population Health Research Institute and the Hamilton Health Science Research Institute, and an investigator-initiated study grant from Roche Diagnostics International.

Funding Information:
Primary Funding Source: Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong.

Publisher Copyright:
© 2023 American College of Physicians.

Access to Document

10.7326/M22-3157

Cite this

Marcucci, M., Painter, T. W., POISE-3 Trial Investigators and Study Groups, Conen, D., Lomivorotov, V., Sessler, D. I., Chan, M. T. V., Borges, F. K., Leslie, K., Duceppe, E., Martínez-Zapata, M. J., Wang, C. Y., Xavier, D., Ofori, S. N., Wang, M. K., Efremov, S., Landoni, G., Kleinlugtenbelt, Y. V., Szczeklik, W., ... van Lier, F. (2023). Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery: An International Randomized Controlled Trial. Annals of Internal Medicine, 176(5), 605-614. https://doi.org/10.7326/M22-3157

@article{70522abd87474eb0a970b932bee11c51,

title = "Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery: An International Randomized Controlled Trial",

abstract = "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]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term.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.",

author = "Maura Marcucci and Painter, \{Thomas W\} and \{POISE-3 Trial Investigators and Study Groups\} and David Conen and Vladimir Lomivorotov and Sessler, \{Daniel I\} and Chan, \{Matthew T V\} and Borges, \{Flavia K\} and Kate Leslie and Emmanuelle Duceppe and Mart{\'i}nez-Zapata, \{Mar{\'i}a Jos{\'e}\} and Wang, \{Chew Yin\} and Denis Xavier and Ofori, \{Sandra N\} and Wang, \{Michael Ke\} and Sergey Efremov and Giovanni Landoni and Kleinlugtenbelt, \{Ydo V\} and Wojciech Szczeklik and Denis Schmartz and Garg, \{Amit X\} and Short, \{Timothy G\} and Maria Wittmann and Meyhoff, \{Christian S\} and Mohammed Amir and David Torres and Ameen Patel and Kurt Ruetzler and Parlow, \{Joel L\} and Vikas Tandon and Edith Fleischmann and Polanczyk, \{Carisi A\} and Andre Lamy and Raja Jayaram and Astrakov, \{Sergey V\} and Wu, \{William Ka Kei\} and Cheong, \{Chao Chia\} and Sabry Ayad and Mikhail Kirov and \{de Nadal\}, Miriam and Likhvantsev, \{Valery V\} and Pilar Paniagua and Aguado, \{Hector J\} and Kamal Maheshwari and Whitlock, \{Richard P\} and McGillion, \{Michael H\} and Jessica Vincent and Ingrid Copland and Kumar Balasubramanian and Biccard, \{Bruce M\} and Sadeesh Srinathan and \{van Lier\}, Felix",

note = "Funding Information: Financial Support: By Canadian Institutes of Health Research Foundation Grant awarded to Dr. Devereaux (FDN-143302); National Health and Medical Research Council, Funding Schemes, NHMRC Project Grant 1162362; and General Research Fund 14104419, Research Grant Council, Hong Kong SAR, China. POISE-3 also received financial support from the Population Health Research Institute and the Hamilton Health Science Research Institute, and an investigator-initiated study grant from Roche Diagnostics International. Funding Information: Primary Funding Source: Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong. Publisher Copyright: {\textcopyright} 2023 American College of Physicians.",

year = "2023",

month = may,

day = "1",

doi = "10.7326/M22-3157",

language = "English",

volume = "176",

pages = "605--614",

journal = "Annals of Internal Medicine",

issn = "0003-4819",

publisher = "American College of Physicians",

number = "5",

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Marcucci, M, Painter, TW, POISE-3 Trial Investigators and Study Groups, Conen, D, Lomivorotov, V, Sessler, DI, Chan, MTV, Borges, FK, Leslie, K, Duceppe, E, Martínez-Zapata, MJ, Wang, CY, Xavier, D, Ofori, SN, Wang, MK, Efremov, S, Landoni, G, Kleinlugtenbelt, YV, Szczeklik, W, Schmartz, D, Garg, AX, Short, TG, Wittmann, M, Meyhoff, CS, Amir, M, Torres, D, Patel, A, Ruetzler, K, Parlow, JL, Tandon, V, Fleischmann, E, Polanczyk, CA, Lamy, A, Jayaram, R, Astrakov, SV, Wu, WKK, Cheong, CC, Ayad, S, Kirov, M, de Nadal, M, Likhvantsev, VV, Paniagua, P, Aguado, HJ, Maheshwari, K, Whitlock, RP, McGillion, MH, Vincent, J, Copland, I, Balasubramanian, K, Biccard, BM, Srinathan, S & van Lier, F 2023, 'Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery: An International Randomized Controlled Trial', Annals of Internal Medicine, vol. 176, no. 5, pp. 605-614. https://doi.org/10.7326/M22-3157

Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery: An International Randomized Controlled Trial. / Marcucci, Maura; Painter, Thomas W; POISE-3 Trial Investigators and Study Groups et al.
In: Annals of Internal Medicine, Vol. 176, No. 5, 01.05.2023, p. 605-614.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery

T2 - An International Randomized Controlled Trial

AU - Marcucci, Maura

AU - Painter, Thomas W

AU - POISE-3 Trial Investigators and Study Groups

AU - Conen, David

AU - Lomivorotov, Vladimir

AU - Sessler, Daniel I

AU - Chan, Matthew T V

AU - Borges, Flavia K

AU - Leslie, Kate

AU - Duceppe, Emmanuelle

AU - Martínez-Zapata, María José

AU - Wang, Chew Yin

AU - Xavier, Denis

AU - Ofori, Sandra N

AU - Wang, Michael Ke

AU - Efremov, Sergey

AU - Landoni, Giovanni

AU - Kleinlugtenbelt, Ydo V

AU - Szczeklik, Wojciech

AU - Schmartz, Denis

AU - Garg, Amit X

AU - Short, Timothy G

AU - Wittmann, Maria

AU - Meyhoff, Christian S

AU - Amir, Mohammed

AU - Torres, David

AU - Patel, Ameen

AU - Ruetzler, Kurt

AU - Parlow, Joel L

AU - Tandon, Vikas

AU - Fleischmann, Edith

AU - Polanczyk, Carisi A

AU - Lamy, Andre

AU - Jayaram, Raja

AU - Astrakov, Sergey V

AU - Wu, William Ka Kei

AU - Cheong, Chao Chia

AU - Ayad, Sabry

AU - Kirov, Mikhail

AU - de Nadal, Miriam

AU - Likhvantsev, Valery V

AU - Paniagua, Pilar

AU - Aguado, Hector J

AU - Maheshwari, Kamal

AU - Whitlock, Richard P

AU - McGillion, Michael H

AU - Vincent, Jessica

AU - Copland, Ingrid

AU - Balasubramanian, Kumar

AU - Biccard, Bruce M

AU - Srinathan, Sadeesh

AU - van Lier, Felix

N1 - Funding Information: Financial Support: By Canadian Institutes of Health Research Foundation Grant awarded to Dr. Devereaux (FDN-143302); National Health and Medical Research Council, Funding Schemes, NHMRC Project Grant 1162362; and General Research Fund 14104419, Research Grant Council, Hong Kong SAR, China. POISE-3 also received financial support from the Population Health Research Institute and the Hamilton Health Science Research Institute, and an investigator-initiated study grant from Roche Diagnostics International. Funding Information: Primary Funding Source: Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong. Publisher Copyright: © 2023 American College of Physicians.

PY - 2023/5/1

Y1 - 2023/5/1

N2 - 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]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term.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.

AB - 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]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term.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.

UR - https://www.scopus.com/pages/publications/85159734603

U2 - 10.7326/M22-3157

DO - 10.7326/M22-3157

M3 - Article

C2 - 37094336

SN - 0003-4819

VL - 176

SP - 605

EP - 614

JO - Annals of Internal Medicine

JF - Annals of Internal Medicine

IS - 5

ER -

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

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