TY - JOUR
T1 - Bleeding in Patients With Infarct-Related Cardiogenic Shock
T2 - A DanGer Shock Substudy
AU - Sørensen, Rikke
AU - Møller, Jacob Eifer
AU - Vandenbriele, Christophe
AU - Hassager, Christian
AU - Eiskjær, Hans
AU - Mangner, Norman
AU - Polzin, Amin
AU - Schulze, P Christian
AU - Skurk, Carsten
AU - Nordbeck, Peter
AU - Clemmensen, Peter
AU - Panoulas, Vasileios
AU - Zimmer, Sebastian
AU - Schäfer, Andreas
AU - Christensen, Steffen
AU - Engstrøm, Thomas
AU - Beske, Rasmus Paulin
AU - Frydland, Martin
AU - Jensen, Lisette Okkels
AU - Junker, Anders
AU - Schmidt, Henrik
AU - Udesen, Nanna Louise Junker
AU - Terkelsen, Christian Juhl
AU - Linke, Axel
AU - Holmvang, Lene
AU - DanGer Shock Investigators
N1 - Copyright © 2026 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PY - 2026/2/9
Y1 - 2026/2/9
N2 - BACKGROUND: The microaxial flow pump (mAFP) has demonstrated improved outcomes in selected patients with ST-segment elevation acute myocardial infarction and cardiogenic shock (STEMI-CS). However, its use has been associated with bleeding events.OBJECTIVES: The authors analyzed bleeding in the international multicenter randomized DanGer Shock (Danish German Shock) trial.METHODS: A total of 355 patients with ST-segment elevation acute myocardial infarction and cardiogenic shock were randomized to either mAFP (n = 179) or standard care alone (n = 176). Bleeding events were classified according to Bleeding Academic Research Consortium (BARC) type 3-5.RESULTS: In the mAFP group, 47 patients (26.3% [95% CI: 20.3%-33.2%]) experienced BARC type 3-5 bleeding, compared with 27 (15.3% [95% CI: 10.7%-21.4%]) in the standard care group; P < 0.001. Median follow-up was 121 days (Q1-Q3: 3-180 days). Among the 210 patients treated with any mechanical circulatory support (MCS), 2 of 74 bleeding events (2.7%) occurred in the cath lab, 35 (47.3%) while on MCS, and 37 (50.0%) after the MCS was removed. Bleeding increased with complexity of MCS: OR for BARC 3-5 bleeding with mAFP was 4.94 (95% CI: 2.30-10.65); P < 0.001, with venoarterial extracorporeal membrane oxygenation (VA-ECMO) 8.06 (95% CI: 2.81-23.09); P < 0.001, and with combined mAFP+VA-ECMO 27.40 (95% CI: 9.82-76.43); P < 0.001, no device as reference. Multivariable logistic regression identified use of mAFP, renal replacement therapy, and escalation to VA-ECMO as predictors of BARC type 3-5 bleeding.CONCLUSIONS: Patients randomized to mAFP experienced more bleeding than the standard care group. Bleeding was associated with the complexity of MCS, with one-half of the bleeding events occurring after device removal. (Danish Cardiogenic Shock Trial [DanShock]; NCT01633502).
AB - BACKGROUND: The microaxial flow pump (mAFP) has demonstrated improved outcomes in selected patients with ST-segment elevation acute myocardial infarction and cardiogenic shock (STEMI-CS). However, its use has been associated with bleeding events.OBJECTIVES: The authors analyzed bleeding in the international multicenter randomized DanGer Shock (Danish German Shock) trial.METHODS: A total of 355 patients with ST-segment elevation acute myocardial infarction and cardiogenic shock were randomized to either mAFP (n = 179) or standard care alone (n = 176). Bleeding events were classified according to Bleeding Academic Research Consortium (BARC) type 3-5.RESULTS: In the mAFP group, 47 patients (26.3% [95% CI: 20.3%-33.2%]) experienced BARC type 3-5 bleeding, compared with 27 (15.3% [95% CI: 10.7%-21.4%]) in the standard care group; P < 0.001. Median follow-up was 121 days (Q1-Q3: 3-180 days). Among the 210 patients treated with any mechanical circulatory support (MCS), 2 of 74 bleeding events (2.7%) occurred in the cath lab, 35 (47.3%) while on MCS, and 37 (50.0%) after the MCS was removed. Bleeding increased with complexity of MCS: OR for BARC 3-5 bleeding with mAFP was 4.94 (95% CI: 2.30-10.65); P < 0.001, with venoarterial extracorporeal membrane oxygenation (VA-ECMO) 8.06 (95% CI: 2.81-23.09); P < 0.001, and with combined mAFP+VA-ECMO 27.40 (95% CI: 9.82-76.43); P < 0.001, no device as reference. Multivariable logistic regression identified use of mAFP, renal replacement therapy, and escalation to VA-ECMO as predictors of BARC type 3-5 bleeding.CONCLUSIONS: Patients randomized to mAFP experienced more bleeding than the standard care group. Bleeding was associated with the complexity of MCS, with one-half of the bleeding events occurring after device removal. (Danish Cardiogenic Shock Trial [DanShock]; NCT01633502).
KW - Humans
KW - Male
KW - Female
KW - Shock, Cardiogenic/therapy
KW - Hemorrhage/etiology
KW - Middle Aged
KW - Treatment Outcome
KW - Aged
KW - Risk Factors
KW - Time Factors
KW - ST Elevation Myocardial Infarction/therapy
KW - Risk Assessment
KW - Denmark
KW - Germany
KW - Heart-Assist Devices
KW - Extracorporeal Membrane Oxygenation/adverse effects
U2 - 10.1016/j.jcin.2025.10.051
DO - 10.1016/j.jcin.2025.10.051
M3 - Article
C2 - 41672689
SN - 1936-8798
VL - 19
SP - 302
EP - 312
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 3
ER -