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Møller, Jacob E; Engstrøm, Thomas; Jensen, Lisette O; Eiskjær, Hans; Mangner, Norman; Polzin, Amin; Schulze, P Christian; Skurk, Carsten; Nordbeck, Peter; Clemmensen, Peter; Panoulas, Vasileios; Zimmer, Sebastian; Schäfer, Andreas; Werner, Nikos; Frydland, Martin; Holmvang, Lene; Kjærgaard, Jesper; Sørensen, Rikke; Lønborg, Jacob; Lindholm, Matias G; Udesen, Nanna L J; Junker, Anders; Schmidt, Henrik; Terkelsen, Christian J; Christensen, Steffen; Christiansen, Evald H; Linke, Axel; Woitek, Felix J; Westenfeld, Ralf; Möbius-Winkler, Sven; Wachtell, Kristian; Ravn, Hanne B; Lassen, Jens F; Boesgaard, Søren; Gerke, Oke; Hassager, Christian
The New England journal of medicine, 2024-Apr-18, Letnik: 390, Številka: 15Journal Article
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. 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. 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). 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.).
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