Article Impact Level: HIGH Data Quality: STRONG Summary of New England Journal of Medicine, 390(15), 1382–1393. https://doi.org/10.1056/NEJMoa2312572 Dr. Jacob E. Møller et al.
Points
- An international, multicenter trial assessed microaxial flow pump (Impella CP) plus standard care vs. standard care alone in STEMI-related cardiogenic shock.
- Primary endpoint: death from any cause at 180 days; composite safety endpoint included severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation
- Analysis of 355 patients revealed a lower death rate in the microaxial-flow-pump group (45.8%) vs. standard-care group (58.5%), with a hazard ratio of 0.74 (95% CI, 0.55 to 0.99; P = 0.04)
- The incidence of composite safety endpoint was higher in the microaxial-flow-pump group (24.0% vs. 6.2% in the standard care group), with increased use of renal-replacement therapy (41.9% vs. 26.7%)
- Routine use of a microaxial flow pump with standard care reduced the risk of death at 180 days. However, it was associated with a higher incidence of adverse events and increased utilization of renal replacement therapy.
Summary
In an international, multicenter, randomized trial, patients with ST-segment elevation myocardial infarction (STEMI) and cardiogenic shock were assigned to receive either a microaxial flow pump (Impella CP) in addition to standard care or standard care alone. The primary endpoint of the study was death from any cause at 180 days, while a composite safety endpoint encompassed severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation. The analysis included 355 patients, 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.
The study revealed that death from any cause occurred in 45.8% of patients in the microaxial-flow-pump group, compared to 58.5% in the standard-care group, resulting in a hazard ratio of 0.74 (95% confidence interval [CI], 0.55 to 0.99; P = 0.04). Additionally, the composite safety endpoint incidence was notably higher in the microaxial-flow-pump group, with 24.0% experiencing adverse events compared to 6.2% in the standard-care group. Renal-replacement therapy was also more frequently administered to patients in the microaxial-flow-pump group, with 41.9% receiving it compared to 26.7% in the standard-care group.
In conclusion, the study demonstrated that the routine use of a microaxial flow pump alongside standard care in the treatment of patients with STEMI-related cardiogenic shock was associated with a reduced risk of death from any cause at 180 days compared to standard care alone. However, it also highlighted a higher incidence of adverse events, as indicated by the composite safety endpoint, and increased utilization of renal-replacement therapy in the microaxial-flow-pump group.
Link to the article: https://www.nejm.org/doi/10.1056/NEJMoa2312572
References 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., … Hassager, C. (2024). Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. New England Journal of Medicine, 390(15), 1382–1393. https://doi.org/10.1056/NEJMoa2312572
