From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.E.M., T.E., M.F., L.H., J.K., R.S., J.L., S.B., C.H.), and the Department of Clinical Medicine, University of Copenhagen (T.E., L.H., C.H.), Copenhagen, the Departments of Cardiology (J.E.M., L.O.J., N.L.J.U., A.J., J.F.L.), Anesthesiology and Intensive Care (H.S., H.B.R.), and Nuclear Medicine (O.G.), Odense University Hospital, and the Department of Clinical Research, University of Southern Denmark (J.E.M., L.O.J., H.B.R., J.F.L.), Odense, the Departments of Cardiology (H.E., C.J.T., E.H.C.) and Anesthesiology and Intensive Care Medicine (S.C.), Aarhus University Hospital, Aarhus, and the Department of Cardiology, Zealand University Hospital, Roskilde (P.C., M.G.L.) - all in Denmark; the Department of Internal Medicine and Cardiology, Heart Center Dresden, University Hospital, Technische Universität Dresden, Dresden (N.M., A.L., F.J.W.), the Department of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Düsseldorf, Medical Faculty of the Heinrich Heine University Düsseldorf, and the Cardiovascular Research Institute Düsseldorf, Düsseldorf (A.P., R.W.), the Department of Internal Medicine I, Cardiology, Angiology, and Intensive Medical Care, University Hospital Jena, Jena (P.C.S., S.M.-W.), the Department of Cardiology, Angiology, and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin, and Deutsches Zentrum für Herz Kreislauf Forschung, Berlin (C.S.), the Department of Internal Medicine I, University Hospital Würzburg, Würzburg (P.N.), the Department of Cardiology, University Heart and Vascular Center, University Clinic Hamburg-Eppendorf, Hamburg (P.C.), the Department of Cardiology, University Hospital Bonn, Bonn (S.Z.), the Department of Cardiology and Angiology, Hannover Medical School, Hannover (A.S.), and the Department of Internal Medicine III, Heart Center Trier, Krankenhaus der Barmherzigen Brüder, Trier (N.W.) - all in Germany; the Department of Cardiology, Royal Brompton and Harefield Hospitals, Guy's and St. Thomas' NHS Foundation Trust, Harefield Hospital, Harefield, United Kingdom (V.P.); and the Greenberg Division of Cardiology, Department of Medicine, Weill Cornell Medicine, New York (K.W.).
N Engl J Med. 2024 Apr 18;390(15):1382-1393. doi: 10.1056/NEJMoa2312572. Epub 2024 Apr 7.
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.).
在 ST 段抬高型心肌梗死（STEMI）合并心原性休克的患者中，使用微型轴流泵的临时机械循环支持对死亡率的影响尚不清楚。
在一项国际性、多中心、随机试验中，我们将 STEMI 合并心原性休克的患者随机分为接受微型轴流泵（Impella CP）加标准治疗组或单纯标准治疗组。主要终点为 180 天的任何原因死亡。复合安全终点为严重出血、肢体缺血、溶血、器械故障或主动脉瓣反流恶化。
共有 360 例患者接受了随机分组，其中 355 例患者纳入最终分析（微型轴流泵组 179 例，标准治疗组 176 例）。患者的中位年龄为 67 岁，79.2%为男性。微型轴流泵组 179 例患者中有 82 例（45.8%）死亡，标准治疗组 176 例患者中有 103 例（58.5%）死亡（风险比，0.74；95%置信区间[CI]，0.55 至 0.99；P=0.04）。微型轴流泵组 43 例（24.0%）发生复合安全终点事件，标准治疗组 11 例（6.2%）（相对风险，4.74；95%CI，2.36 至 9.55）。微型轴流泵组 75 例（41.9%）患者接受了肾脏替代治疗，标准治疗组 47 例（26.7%）（相对风险，1.98；95%CI，1.27 至 3.09）。
在 STEMI 相关心原性休克患者的治疗中，常规使用微型轴流泵联合标准治疗可降低 180 天的全因死亡率，而复合不良事件的发生率则更高。（由丹麦心脏基金会和 Abiomed 资助；DanGer Shock ClinicalTrials.gov 编号，NCT01633502。）
