Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock
Copyright © 2024 Massachusetts Medical Society..
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.).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:390 |
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| Enthalten in: |
The New England journal of medicine - 390(2024), 15 vom: 18. Apr., Seite 1382-1393 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Møller, Jacob E [VerfasserIn] |
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| Links: |
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| Themen: |
Comparative Study |
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| Anmerkungen: |
Date Completed 19.04.2024 Date Revised 20.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT01633502 Citation Status MEDLINE |
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| doi: |
10.1056/NEJMoa2312572 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Møller, Jacob E |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock |
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| 500 | |a Date Completed 19.04.2024 | ||
| 500 | |a Date Revised 20.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01633502 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 Massachusetts Medical Society. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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.) | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 700 | 1 | |a Engstrøm, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Jensen, Lisette O |e verfasserin |4 aut | |
| 700 | 1 | |a Eiskjær, Hans |e verfasserin |4 aut | |
| 700 | 1 | |a Mangner, Norman |e verfasserin |4 aut | |
| 700 | 1 | |a Polzin, Amin |e verfasserin |4 aut | |
| 700 | 1 | |a Schulze, P Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Skurk, Carsten |e verfasserin |4 aut | |
| 700 | 1 | |a Nordbeck, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Clemmensen, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Panoulas, Vasileios |e verfasserin |4 aut | |
| 700 | 1 | |a Zimmer, Sebastian |e verfasserin |4 aut | |
| 700 | 1 | |a Schäfer, Andreas |e verfasserin |4 aut | |
| 700 | 1 | |a Werner, Nikos |e verfasserin |4 aut | |
| 700 | 1 | |a Frydland, Martin |e verfasserin |4 aut | |
| 700 | 1 | |a Holmvang, Lene |e verfasserin |4 aut | |
| 700 | 1 | |a Kjærgaard, Jesper |e verfasserin |4 aut | |
| 700 | 1 | |a Sørensen, Rikke |e verfasserin |4 aut | |
| 700 | 1 | |a Lønborg, Jacob |e verfasserin |4 aut | |
| 700 | 1 | |a Lindholm, Matias G |e verfasserin |4 aut | |
| 700 | 1 | |a Udesen, Nanna L J |e verfasserin |4 aut | |
| 700 | 1 | |a Junker, Anders |e verfasserin |4 aut | |
| 700 | 1 | |a Schmidt, Henrik |e verfasserin |4 aut | |
| 700 | 1 | |a Terkelsen, Christian J |e verfasserin |4 aut | |
| 700 | 1 | |a Christensen, Steffen |e verfasserin |4 aut | |
| 700 | 1 | |a Christiansen, Evald H |e verfasserin |4 aut | |
| 700 | 1 | |a Linke, Axel |e verfasserin |4 aut | |
| 700 | 1 | |a Woitek, Felix J |e verfasserin |4 aut | |
| 700 | 1 | |a Westenfeld, Ralf |e verfasserin |4 aut | |
| 700 | 1 | |a Möbius-Winkler, Sven |e verfasserin |4 aut | |
| 700 | 1 | |a Wachtell, Kristian |e verfasserin |4 aut | |
| 700 | 1 | |a Ravn, Hanne B |e verfasserin |4 aut | |
| 700 | 1 | |a Lassen, Jens F |e verfasserin |4 aut | |
| 700 | 1 | |a Boesgaard, Søren |e verfasserin |4 aut | |
| 700 | 1 | |a Gerke, Oke |e verfasserin |4 aut | |
| 700 | 1 | |a Hassager, Christian |e verfasserin |4 aut | |
| 700 | 0 | |a DanGer Shock Investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Møller, Jacob Eifer |e investigator |4 oth | |
| 700 | 1 | |a Okkels Jensen, Lisette |e investigator |4 oth | |
| 700 | 1 | |a Junker, Anders |e investigator |4 oth | |
| 700 | 1 | |a Tange Veien, Karsten |e investigator |4 oth | |
| 700 | 1 | |a Junker Udesen, Nanna Louise |e investigator |4 oth | |
| 700 | 1 | |a Schmidt, Henrik |e investigator |4 oth | |
| 700 | 1 | |a Hassager, Christian |e investigator |4 oth | |
| 700 | 1 | |a Engstrøm, Thomas |e investigator |4 oth | |
| 700 | 1 | |a Holmvang, Lene |e investigator |4 oth | |
| 700 | 1 | |a Kjaergaard, Jesper |e investigator |4 oth | |
| 700 | 1 | |a Sørensen, Rikke |e investigator |4 oth | |
| 700 | 1 | |a Lønborg, Jacob |e investigator |4 oth | |
| 700 | 1 | |a Fryldand, Martin |e investigator |4 oth | |
| 700 | 1 | |a Paulin Beske, Rasmus |e investigator |4 oth | |
| 700 | 1 | |a Boesgaard, Søren |e investigator |4 oth | |
| 700 | 1 | |a Eiskjær, Hans |e investigator |4 oth | |
| 700 | 1 | |a Christensen, Steffen |e investigator |4 oth | |
| 700 | 1 | |a Christiansen, Evald Høj |e investigator |4 oth | |
| 700 | 1 | |a Terkelsen, Christian Juhl |e investigator |4 oth | |
| 700 | 1 | |a Schäfer, Andreas |e investigator |4 oth | |
| 700 | 1 | |a Linke, Axel |e investigator |4 oth | |
| 700 | 1 | |a Woitek, Felix J |e investigator |4 oth | |
| 700 | 1 | |a Hommel, Jennifer |e investigator |4 oth | |
| 700 | 1 | |a Mangner, Norman |e investigator |4 oth | |
| 700 | 1 | |a Polzin, Amin |e investigator |4 oth | |
| 700 | 1 | |a Westenfeld, Ralf |e investigator |4 oth | |
| 700 | 1 | |a Schulze, Christian |e investigator |4 oth | |
| 700 | 1 | |a Moebius-Winkler, Sven |e investigator |4 oth | |
| 700 | 1 | |a Skurk, Carsten |e investigator |4 oth | |
| 700 | 1 | |a Nordbeck, Peter |e investigator |4 oth | |
| 700 | 1 | |a Clemmensen, Peter |e investigator |4 oth | |
| 700 | 1 | |a Westermann, Dirk |e investigator |4 oth | |
| 700 | 1 | |a Panoulas, Vasileios |e investigator |4 oth | |
| 700 | 1 | |a Zimmer, Sebastian |e investigator |4 oth | |
| 700 | 1 | |a Werner, Nicos |e investigator |4 oth | |
| 700 | 1 | |a Wachtell, Kristian |e investigator |4 oth | |
| 700 | 1 | |a Berg Ravn, Hanne |e investigator |4 oth | |
| 700 | 1 | |a Flensted Lassen, Jens |e investigator |4 oth | |
| 700 | 1 | |a De Haas, Inge |e investigator |4 oth | |
| 700 | 1 | |a Gerke, Oke |e investigator |4 oth | |
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