收缩压和微轴流泵在梗死相关性心源性休克中的相关生存：危险休克随机临床试验的事后分析

IF 14.1 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JAMA cardiology Pub Date : 2025-08-30 DOI:10.1001/jamacardio.2025.3337

Astrid Duus Mikkelsen, Rasmus Paulin Beske, Lisette Okkels Jensen, Hans Eiskjær, Norman Mangner, Amin Polzin, Christian Schulze, Carsten Skurk, Peter Nordbeck, Benedikt Schrage, Vasileios Panoulas, Sebastian Zimmer, Andreas Schäfer, Thomas Engstrøm, Lene Holmvang, Martin Frydland, Anders Bo Junker, Henrik Schmidt, Nanna Louise Junker Udesen, Kristian Wachtell, Christian Juhl Terkelsen, Axel Linke, Jesper Kjærgaard, Jacob Eifer Møller, Christian Hassager

{"title":"收缩压和微轴流泵在梗死相关性心源性休克中的相关生存：危险休克随机临床试验的事后分析","authors":"Astrid Duus Mikkelsen, Rasmus Paulin Beske, Lisette Okkels Jensen, Hans Eiskjær, Norman Mangner, Amin Polzin, Christian Schulze, Carsten Skurk, Peter Nordbeck, Benedikt Schrage, Vasileios Panoulas, Sebastian Zimmer, Andreas Schäfer, Thomas Engstrøm, Lene Holmvang, Martin Frydland, Anders Bo Junker, Henrik Schmidt, Nanna Louise Junker Udesen, Kristian Wachtell, Christian Juhl Terkelsen, Axel Linke, Jesper Kjærgaard, Jacob Eifer Møller, Christian Hassager","doi":"10.1001/jamacardio.2025.3337","DOIUrl":null,"url":null,"abstract":"Importance: Microaxial flow pump treatment improves survival in selected patients with infarct-related cardiogenic shock; however, treatment carries substantial risks, and benefit may vary by patient subgroup. Systolic blood pressure (SBP) has been proposed as a modifier of the survival benefit.Objective: To investigate whether SBP at randomization modifies the survival benefit of microaxial flow pump treatment in ST-segment elevation myocardial infarction-related cardiogenic shock.Design, setting, and participants: This was a post hoc analysis of the Danish-German (DanGer) Shock open-label randomized clinical trial among adult patients with ST-segment elevation myocardial infarction complicated by cardiogenic shock, conducted between 2013 and 2023 at 14 tertiary invasive cardiac centers in Denmark, Germany, and the United Kingdom. Data analysis was performed from January 7 to April 7, 2024.Intervention: Microaxial flow pump therapy plus standard care vs standard care alone.Main outcomes and measures: All-cause mortality at 180 days according to randomization SBP.Results: Of 355 patients included in the DanGer Shock trial, 351 patients had available SBP at randomization (median [IQR] age, 69 [59-76] years; 277 [79%] male). In a dichotomized regression analysis, microaxial flow pump treatment significantly reduced mortality for SBPs lower than 82 mm Hg compared with standard care alone (odds ratio [OR], 0.34; 95% CI, 0.18-0.63; P < .001). This was not evident for higher pressures (OR, 0.96; 95% CI, 0.53-1.70; P = .90; P for interaction = .02). Kaplan-Meier survival analysis and spline regression analysis supported these findings (P for interaction = .02; P for nonlinearity = .01).Conclusions and relevance: Randomization SBP was associated with the survival benefit of microaxial flow pump treatment, with the most hypotensive patients deriving the largest survival benefit. Early SBP may help identify patients most likely to gain a net benefit from microaxial flow pump treatment. Findings are hypothesis generating.Trial registration: ClinicalTrials.gov Identifier: NCT01633502.","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":""},"PeriodicalIF":14.1000,"publicationDate":"2025-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398770/pdf/","citationCount":"0","resultStr":"{\"title\":\"Systolic Blood Pressure and Microaxial Flow Pump-Associated Survival in Infarct-Related Cardiogenic Shock: A Post Hoc Analysis of the DanGer Shock Randomized Clinical Trial.\",\"authors\":\"Astrid Duus Mikkelsen, Rasmus Paulin Beske, Lisette Okkels Jensen, Hans Eiskjær, Norman Mangner, Amin Polzin, Christian Schulze, Carsten Skurk, Peter Nordbeck, Benedikt Schrage, Vasileios Panoulas, Sebastian Zimmer, Andreas Schäfer, Thomas Engstrøm, Lene Holmvang, Martin Frydland, Anders Bo Junker, Henrik Schmidt, Nanna Louise Junker Udesen, Kristian Wachtell, Christian Juhl Terkelsen, Axel Linke, Jesper Kjærgaard, Jacob Eifer Møller, Christian Hassager\",\"doi\":\"10.1001/jamacardio.2025.3337\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Importance: Microaxial flow pump treatment improves survival in selected patients with infarct-related cardiogenic shock; however, treatment carries substantial risks, and benefit may vary by patient subgroup. Systolic blood pressure (SBP) has been proposed as a modifier of the survival benefit.Objective: To investigate whether SBP at randomization modifies the survival benefit of microaxial flow pump treatment in ST-segment elevation myocardial infarction-related cardiogenic shock.Design, setting, and participants: This was a post hoc analysis of the Danish-German (DanGer) Shock open-label randomized clinical trial among adult patients with ST-segment elevation myocardial infarction complicated by cardiogenic shock, conducted between 2013 and 2023 at 14 tertiary invasive cardiac centers in Denmark, Germany, and the United Kingdom. Data analysis was performed from January 7 to April 7, 2024.Intervention: Microaxial flow pump therapy plus standard care vs standard care alone.Main outcomes and measures: All-cause mortality at 180 days according to randomization SBP.Results: Of 355 patients included in the DanGer Shock trial, 351 patients had available SBP at randomization (median [IQR] age, 69 [59-76] years; 277 [79%] male). In a dichotomized regression analysis, microaxial flow pump treatment significantly reduced mortality for SBPs lower than 82 mm Hg compared with standard care alone (odds ratio [OR], 0.34; 95% CI, 0.18-0.63; P < .001). This was not evident for higher pressures (OR, 0.96; 95% CI, 0.53-1.70; P = .90; P for interaction = .02). Kaplan-Meier survival analysis and spline regression analysis supported these findings (P for interaction = .02; P for nonlinearity = .01).Conclusions and relevance: Randomization SBP was associated with the survival benefit of microaxial flow pump treatment, with the most hypotensive patients deriving the largest survival benefit. Early SBP may help identify patients most likely to gain a net benefit from microaxial flow pump treatment. Findings are hypothesis generating.Trial registration: ClinicalTrials.gov Identifier: NCT01633502.\",\"PeriodicalId\":14657,\"journal\":{\"name\":\"JAMA cardiology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":14.1000,\"publicationDate\":\"2025-08-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398770/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JAMA cardiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1001/jamacardio.2025.3337\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA cardiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jamacardio.2025.3337","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

摘要

重要性：微轴流泵治疗可提高梗死相关性心源性休克患者的生存率；然而，这种治疗有很大的风险，而且益处可能因患者亚组而异。收缩压（SBP）被认为是生存获益的调节因子。目的：探讨随机收缩压是否会改变微轴流泵治疗st段抬高型心肌梗死相关性心源性休克的生存获益。设计、环境和参与者：这是一项丹麦-德国（DanGer）休克开放标签随机临床试验的事后分析，该试验于2013年至2023年在丹麦、德国和英国的14个三级有创心脏中心进行，研究对象为st段抬高型心肌梗死合并心源性休克的成年患者。数据分析时间为2024年1月7日至4月7日。干预：微轴流泵治疗加标准治疗vs单独标准治疗。主要结局和指标：根据随机收缩压，180天全因死亡率。结果：在危险休克试验中纳入的355例患者中，351例患者在随机分组时具有可用收缩压（中位[IQR]年龄，69[59-76]岁；277[79%]男性）。在二分类回归分析中，与单纯标准治疗相比，微轴流泵治疗显著降低了小于82毫米汞柱的SBP死亡率（优势比[OR]， 0.34; 95% CI, 0.18-0.63； P）。结论和相关性：随机化SBP与微轴流泵治疗的生存获益相关，最低血压患者获得的生存获益最大。早期收缩压可能有助于确定最有可能从微轴流泵治疗中获得净收益的患者。研究结果产生假设。试验注册：ClinicalTrials.gov标识符：NCT01633502。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Systolic Blood Pressure and Microaxial Flow Pump-Associated Survival in Infarct-Related Cardiogenic Shock: A Post Hoc Analysis of the DanGer Shock Randomized Clinical Trial.

Importance: Microaxial flow pump treatment improves survival in selected patients with infarct-related cardiogenic shock; however, treatment carries substantial risks, and benefit may vary by patient subgroup. Systolic blood pressure (SBP) has been proposed as a modifier of the survival benefit.

Objective: To investigate whether SBP at randomization modifies the survival benefit of microaxial flow pump treatment in ST-segment elevation myocardial infarction-related cardiogenic shock.

Design, setting, and participants: This was a post hoc analysis of the Danish-German (DanGer) Shock open-label randomized clinical trial among adult patients with ST-segment elevation myocardial infarction complicated by cardiogenic shock, conducted between 2013 and 2023 at 14 tertiary invasive cardiac centers in Denmark, Germany, and the United Kingdom. Data analysis was performed from January 7 to April 7, 2024.

Intervention: Microaxial flow pump therapy plus standard care vs standard care alone.

Main outcomes and measures: All-cause mortality at 180 days according to randomization SBP.

Results: Of 355 patients included in the DanGer Shock trial, 351 patients had available SBP at randomization (median [IQR] age, 69 [59-76] years; 277 [79%] male). In a dichotomized regression analysis, microaxial flow pump treatment significantly reduced mortality for SBPs lower than 82 mm Hg compared with standard care alone (odds ratio [OR], 0.34; 95% CI, 0.18-0.63; P < .001). This was not evident for higher pressures (OR, 0.96; 95% CI, 0.53-1.70; P = .90; P for interaction = .02). Kaplan-Meier survival analysis and spline regression analysis supported these findings (P for interaction = .02; P for nonlinearity = .01).

Conclusions and relevance: Randomization SBP was associated with the survival benefit of microaxial flow pump treatment, with the most hypotensive patients deriving the largest survival benefit. Early SBP may help identify patients most likely to gain a net benefit from microaxial flow pump treatment. Findings are hypothesis generating.

Trial registration: ClinicalTrials.gov Identifier: NCT01633502.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

JAMA cardiology Medicine-Cardiology and Cardiovascular Medicine

CiteScore

45.80

自引率

1.70%

发文量

264

期刊介绍： JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications. Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program. Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.