Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery

C David Mazer; Richard P Whitlock; Dean A Fergusson; Judith Hall; Emilie Belley-Cote; Katherine Connolly; Boris Khanykin; Alexander J Gregory; Étienne de Médicis; Shay McGuinness; Alistair Royse; François M Carrier; Paul J Young; Juan C Villar; Hilary P Grocott; Manfred D Seeberger; Stephen Fremes; François Lellouche; Summer Syed; Kelly Byrne; Sean M Bagshaw; Nian C Hwang; Chirag Mehta; Thomas W Painter; Colin Royse; Subodh Verma; Gregory M T Hare; Ashley Cohen; Kevin E Thorpe; Peter Jüni; Nadine Shehata; TRICS Investigators and Perioperative Anesthesia Clinical Trials Group; Pär Ingemar Johansson

doi:10.1056/NEJMoa1711818

Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery

C David Mazer, Richard P Whitlock, Dean A Fergusson, Judith Hall, Emilie Belley-Cote, Katherine Connolly, Boris Khanykin, Alexander J Gregory, Étienne de Médicis, Shay McGuinness, Alistair Royse, François M Carrier, Paul J Young, Juan C Villar, Hilary P Grocott, Manfred D Seeberger, Stephen Fremes, François Lellouche, Summer Syed, Kelly ByrneSean M Bagshaw, Nian C Hwang, Chirag Mehta, Thomas W Painter, Colin Royse, Subodh Verma, Gregory M T Hare, Ashley Cohen, Kevin E Thorpe, Peter Jüni, Nadine Shehata, TRICS Investigators and Perioperative Anesthesia Clinical Trials Group, Pär Ingemar Johansson

628 Citationer (Scopus)

Abstract

BACKGROUND: The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear.

METHODS: In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes.

RESULTS: The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, -1.11 percentage points; 95% confidence interval [CI], -2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes.

CONCLUSIONS: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).

Originalsprog	Engelsk
Tidsskrift	The New England journal of medicine
Vol/bind	377
Udgave nummer	22
Sider (fra-til)	2133-2144
Antal sider	12
ISSN	0028-4793
DOI	https://doi.org/10.1056/NEJMoa1711818
Status	Udgivet - 30 nov. 2017

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10.1056/NEJMoa1711818

Citationsformater

Mazer, C. D., Whitlock, R. P., Fergusson, D. A., Hall, J., Belley-Cote, E., Connolly, K., Khanykin, B., Gregory, A. J., de Médicis, É., McGuinness, S., Royse, A., Carrier, F. M., Young, P. J., Villar, J. C., Grocott, H. P., Seeberger, M. D., Fremes, S., Lellouche, F., Syed, S., ... Johansson, P. I. (2017). Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. The New England journal of medicine, 377(22), 2133-2144. https://doi.org/10.1056/NEJMoa1711818

Mazer, CD, Whitlock, RP, Fergusson, DA, Hall, J, Belley-Cote, E, Connolly, K, Khanykin, B, Gregory, AJ, de Médicis, É, McGuinness, S, Royse, A, Carrier, FM, Young, PJ, Villar, JC, Grocott, HP, Seeberger, MD, Fremes, S, Lellouche, F, Syed, S, Byrne, K, Bagshaw, SM, Hwang, NC, Mehta, C, Painter, TW, Royse, C, Verma, S, Hare, GMT, Cohen, A, Thorpe, KE, Jüni, P, Shehata, N, TRICS Investigators and Perioperative Anesthesia Clinical Trials Group & Johansson, PI 2017, 'Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery', The New England journal of medicine, bind 377, nr. 22, s. 2133-2144. https://doi.org/10.1056/NEJMoa1711818

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title = "Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery",

abstract = "BACKGROUND: The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear.METHODS: In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes.RESULTS: The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, -1.11 percentage points; 95% confidence interval [CI], -2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes.CONCLUSIONS: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).",

keywords = "Adult, Aged, Cardiac Surgical Procedures, Cardiopulmonary Bypass, Erythrocyte Transfusion, Female, Hemoglobins, Hospital Mortality, Humans, Intensive Care Units, Intention to Treat Analysis, Length of Stay, Male, Middle Aged, Myocardial Infarction, Perioperative Care, Postoperative Complications, Renal Insufficiency, Stroke, Equivalence Trial, Journal Article, Multicenter Study, Randomized Controlled Trial",

author = "Mazer, {C David} and Whitlock, {Richard P} and Fergusson, {Dean A} and Judith Hall and Emilie Belley-Cote and Katherine Connolly and Boris Khanykin and Gregory, {Alexander J} and {de M{\'e}dicis}, {\'E}tienne and Shay McGuinness and Alistair Royse and Carrier, {Fran{\c c}ois M} and Young, {Paul J} and Villar, {Juan C} and Grocott, {Hilary P} and Seeberger, {Manfred D} and Stephen Fremes and Fran{\c c}ois Lellouche and Summer Syed and Kelly Byrne and Bagshaw, {Sean M} and Hwang, {Nian C} and Chirag Mehta and Painter, {Thomas W} and Colin Royse and Subodh Verma and Hare, {Gregory M T} and Ashley Cohen and Thorpe, {Kevin E} and Peter J{\"u}ni and Nadine Shehata and {TRICS Investigators and Perioperative Anesthesia Clinical Trials Group} and Johansson, {P{\"a}r Ingemar}",

year = "2017",

month = nov,

day = "30",

doi = "10.1056/NEJMoa1711818",

language = "English",

volume = "377",

pages = "2133--2144",

journal = "The New England journal of medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "22",

}

TY - JOUR

T1 - Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery

AU - Mazer, C David

AU - Whitlock, Richard P

AU - Fergusson, Dean A

AU - Hall, Judith

AU - Belley-Cote, Emilie

AU - Connolly, Katherine

AU - Khanykin, Boris

AU - Gregory, Alexander J

AU - de Médicis, Étienne

AU - McGuinness, Shay

AU - Royse, Alistair

AU - Carrier, François M

AU - Young, Paul J

AU - Villar, Juan C

AU - Grocott, Hilary P

AU - Seeberger, Manfred D

AU - Fremes, Stephen

AU - Lellouche, François

AU - Syed, Summer

AU - Byrne, Kelly

AU - Bagshaw, Sean M

AU - Hwang, Nian C

AU - Mehta, Chirag

AU - Painter, Thomas W

AU - Royse, Colin

AU - Verma, Subodh

AU - Hare, Gregory M T

AU - Cohen, Ashley

AU - Thorpe, Kevin E

AU - Jüni, Peter

AU - Shehata, Nadine

AU - TRICS Investigators and Perioperative Anesthesia Clinical Trials Group

AU - Johansson, Pär Ingemar

PY - 2017/11/30

Y1 - 2017/11/30

N2 - BACKGROUND: The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear.METHODS: In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes.RESULTS: The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, -1.11 percentage points; 95% confidence interval [CI], -2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes.CONCLUSIONS: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).

AB - BACKGROUND: The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear.METHODS: In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes.RESULTS: The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, -1.11 percentage points; 95% confidence interval [CI], -2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes.CONCLUSIONS: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).

KW - Adult

KW - Aged

KW - Cardiac Surgical Procedures

KW - Cardiopulmonary Bypass

KW - Erythrocyte Transfusion

KW - Female

KW - Hemoglobins

KW - Hospital Mortality

KW - Humans

KW - Intensive Care Units

KW - Intention to Treat Analysis

KW - Length of Stay

KW - Male

KW - Middle Aged

KW - Myocardial Infarction

KW - Perioperative Care

KW - Postoperative Complications

KW - Renal Insufficiency

KW - Stroke

KW - Equivalence Trial

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

U2 - 10.1056/NEJMoa1711818

DO - 10.1056/NEJMoa1711818

M3 - Journal article

C2 - 29130845

SN - 0028-4793

VL - 377

SP - 2133

EP - 2144

JO - The New England journal of medicine

JF - The New England journal of medicine

IS - 22

ER -

Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery

Abstract

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