JACC. Cardiovascular interventions · 2026
Bleeding in Patients With Infarct-Related Cardiogenic Shock: A DanGer Shock Substudy.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Sørensen Rikke, Møller Jacob Eifer, Vandenbriele Christophe, Hassager Christian, Eiskjær Hans, Mangner Norman, Polzin Amin, Schulze P Christian, Skurk Carsten, Nordbeck Peter, Clemmensen Peter, Panoulas Vasileios, Zimmer Sebastian, Schäfer Andreas, Christensen Steffen, Engstrøm Thomas, Beske Rasmus Paulin, Frydland Martin, Jensen Lisette Okkels, Junker Anders, Schmidt Henrik, Udesen Nanna Louise Junker, Terkelsen Christian Juhl, Linke Axel, Holmvang Lene, DanGer Shock Investigators
Аннотация
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).
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).