Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock

DanGer Shock investigators

doi:10.1056/NEJMoa2312572

Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock

DanGer Shock investigators

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

Abstract

BACKGROUND: The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear.

METHODS: In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation.

RESULTS: A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09).

CONCLUSIONS: The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.).

Originalsprog	Engelsk
Tidsskrift	The New England Journal of Medicine
Vol/bind	390
Nummer	15
Sider (fra-til)	1382-1393
Antal sider	12
ISSN	0028-4793
DOI	https://doi.org/10.1056/NEJMoa2312572
Status	Udgivet - apr. 2024

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10.1056/NEJMoa2312572

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@article{070e109f890b47458846d4655c5aeb3e,

title = "Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock",

abstract = "BACKGROUND: The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear.METHODS: In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation.RESULTS: A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09).CONCLUSIONS: The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.).",

keywords = "Aged, Female, Humans, Male, Heart-Assist Devices/adverse effects, Incidence, Shock, Cardiogenic/etiology, ST Elevation Myocardial Infarction/complications, Treatment Outcome, Assisted Circulation/adverse effects",

author = "M{\o}ller, {Jacob E} and Thomas Engstr{\o}m and Jensen, {Lisette O} and Hans Eiskj{\ae}r and Norman Mangner and Amin Polzin and Schulze, {P Christian} and Carsten Skurk and Peter Nordbeck and Peter Clemmensen and Vasileios Panoulas and Sebastian Zimmer and Andreas Sch{\"a}fer and Nikos Werner and Martin Frydland and Lene Holmvang and Jesper Kj{\ae}rgaard and Rikke S{\o}rensen and Jacob L{\o}nborg and Lindholm, {Matias G} and Udesen, {Nanna L J} and Anders Junker and Henrik Schmidt and Terkelsen, {Christian J} and Steffen Christensen and Christiansen, {Evald H} and Axel Linke and Woitek, {Felix J} and Ralf Westenfeld and Sven M{\"o}bius-Winkler and Kristian Wachtell and Ravn, {Hanne B} and Lassen, {Jens F} and S{\o}ren Boesgaard and Oke Gerke and Christian Hassager and {DanGer Shock investigators}",

note = "Copyright {\textcopyright} 2024 Massachusetts Medical Society.",

year = "2024",

month = apr,

doi = "10.1056/NEJMoa2312572",

language = "English",

volume = "390",

pages = "1382--1393",

journal = "The New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOC",

number = "15",

}

TY - JOUR

T1 - Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock

AU - Møller, Jacob E

AU - Engstrøm, Thomas

AU - Jensen, Lisette O

AU - Eiskjær, Hans

AU - Mangner, Norman

AU - Polzin, Amin

AU - Schulze, P Christian

AU - Skurk, Carsten

AU - Nordbeck, Peter

AU - Clemmensen, Peter

AU - Panoulas, Vasileios

AU - Zimmer, Sebastian

AU - Schäfer, Andreas

AU - Werner, Nikos

AU - Frydland, Martin

AU - Holmvang, Lene

AU - Kjærgaard, Jesper

AU - Sørensen, Rikke

AU - Lønborg, Jacob

AU - Lindholm, Matias G

AU - Udesen, Nanna L J

AU - Junker, Anders

AU - Schmidt, Henrik

AU - Terkelsen, Christian J

AU - Christensen, Steffen

AU - Christiansen, Evald H

AU - Linke, Axel

AU - Woitek, Felix J

AU - Westenfeld, Ralf

AU - Möbius-Winkler, Sven

AU - Wachtell, Kristian

AU - Ravn, Hanne B

AU - Lassen, Jens F

AU - Boesgaard, Søren

AU - Gerke, Oke

AU - Hassager, Christian

AU - DanGer Shock investigators

PY - 2024/4

Y1 - 2024/4

N2 - BACKGROUND: The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear.METHODS: In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation.RESULTS: A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09).CONCLUSIONS: The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.).

AB - BACKGROUND: The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear.METHODS: In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation.RESULTS: A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09).CONCLUSIONS: The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.).

KW - Aged

KW - Female

KW - Humans

KW - Male

KW - Heart-Assist Devices/adverse effects

KW - Incidence

KW - Shock, Cardiogenic/etiology

KW - ST Elevation Myocardial Infarction/complications

KW - Treatment Outcome

KW - Assisted Circulation/adverse effects

UR - http://www.scopus.com/inward/record.url?scp=85190971602&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2312572

DO - 10.1056/NEJMoa2312572

M3 - Journal article

C2 - 38587239

SN - 0028-4793

VL - 390

SP - 1382

EP - 1393

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

IS - 15

ER -

Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock

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