Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock
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Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. / Møller, J. E.; Engstrøm, T.; Jensen, L. O.; Eiskjær, H.; Mangner, N.; Polzin, A.; Schulze, P. C.; Skurk, C.; Nordbeck, P.; Clemmensen, P.; Panoulas, V.; Zimmer, S.; Schäfer, A.; Werner, N.; Frydland, M.; Holmvang, L.; Kjærgaard, J.; Sørensen, R.; Lønborg, J.; Lindholm, M. G.; Udesen, N. L.J.; Junker, A.; Schmidt, H.; Terkelsen, C. J.; Christensen, S.; Christiansen, E. H.; Linke, A.; Woitek, F. J.; Westenfeld, R.; Möbius-Winkler, S.; Wachtell, K.; Ravn, H. B.; Lassen, J. F.; Boesgaard, S.; Gerke, O.; Hassager, C.; for the DanGer Shock Investigators.
In: New England Journal of Medicine, Vol. 390, No. 15, 2024, p. 1382-1393.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock
AU - Møller, J. E.
AU - Engstrøm, T.
AU - Jensen, L. O.
AU - Eiskjær, H.
AU - Mangner, N.
AU - Polzin, A.
AU - Schulze, P. C.
AU - Skurk, C.
AU - Nordbeck, P.
AU - Clemmensen, P.
AU - Panoulas, V.
AU - Zimmer, S.
AU - Schäfer, A.
AU - Werner, N.
AU - Frydland, M.
AU - Holmvang, L.
AU - Kjærgaard, J.
AU - Sørensen, R.
AU - Lønborg, J.
AU - Lindholm, M. G.
AU - Udesen, N. L.J.
AU - Junker, A.
AU - Schmidt, H.
AU - Terkelsen, C. J.
AU - Christensen, S.
AU - Christiansen, E. H.
AU - Linke, A.
AU - Woitek, F. J.
AU - Westenfeld, R.
AU - Möbius-Winkler, S.
AU - Wachtell, K.
AU - Ravn, H. B.
AU - Lassen, J. F.
AU - Boesgaard, S.
AU - Gerke, O.
AU - Hassager, C.
AU - for the DanGer Shock Investigators
N1 - Publisher Copyright: © 2024 Massachussetts Medical Society. All rights reserved.
PY - 2024
Y1 - 2024
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.)
U2 - 10.1056/NEJMoa2312572
DO - 10.1056/NEJMoa2312572
M3 - Journal article
AN - SCOPUS:85190971602
VL - 390
SP - 1382
EP - 1393
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 15
ER -
ID: 391214731