TY - JOUR
T1 - Systolic Blood Pressure and Microaxial Flow Pump-Associated Survival in Infarct-Related Cardiogenic Shock
T2 - A Post Hoc Analysis of the DanGer Shock Randomized Clinical Trial
AU - Mikkelsen, Astrid Duus
AU - Beske, Rasmus Paulin
AU - Jensen, Lisette Okkels
AU - Eiskjær, Hans
AU - Mangner, Norman
AU - Polzin, Amin
AU - Schulze, Christian
AU - Skurk, Carsten
AU - Nordbeck, Peter
AU - Schrage, Benedikt
AU - Panoulas, Vasileios
AU - Zimmer, Sebastian
AU - Schäfer, Andreas
AU - Engstrøm, Thomas
AU - Holmvang, Lene
AU - Frydland, Martin
AU - Junker, Anders Bo
AU - Schmidt, Henrik
AU - Udesen, Nanna Louise Junker
AU - Wachtell, Kristian
AU - Terkelsen, Christian Juhl
AU - Linke, Axel
AU - Kjærgaard, Jesper
AU - Møller, Jacob Eifer
AU - Hassager, Christian
AU - DanGer Shock investigators
PY - 2025/11/1
Y1 - 2025/11/1
N2 - 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.
AB - 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.
KW - Aged
KW - Blood Pressure/physiology
KW - Denmark/epidemiology
KW - Female
KW - Germany/epidemiology
KW - Humans
KW - Male
KW - Middle Aged
KW - ST Elevation Myocardial Infarction/complications
KW - Shock, Cardiogenic/mortality
KW - Survival Rate/trends
KW - Systole
UR - http://www.scopus.com/inward/record.url?scp=105021470326&partnerID=8YFLogxK
U2 - 10.1001/jamacardio.2025.3337
DO - 10.1001/jamacardio.2025.3337
M3 - Journal article
C2 - 40884241
SN - 2380-6583
VL - 10
SP - 1157
EP - 1165
JO - JAMA Cardiology
JF - JAMA Cardiology
IS - 11
ER -