1. Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock
- Author
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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., 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., and Hassager, C.
- 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.), 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.)
- Published
- 2024