TY - JOUR

T1 - Rationale and design of DanGer shock

T2 - Danish-German cardiogenic shock trial

AU - Udesen, Nanna Junker

AU - Møller, Jacob Eifer

AU - Lindholm, Matias Greve

AU - Eiskjær, Hans

AU - Schäfer, Andreas

AU - Werner, Nikos

AU - Holmvang, Lene

AU - Terkelsen, Christian Juhl

AU - Jensen, Lisette Okkels

AU - Junker, Anders

AU - Schmidt, Henrik

AU - Wachtell, Kristian

AU - Thiele, Holger

AU - Engstrøm, Thomas

AU - Hassager, Christian

AU - DanGer Shock investigators

N1 - Copyright © 2019 The Author(s). Published by Elsevier Inc. All rights reserved.

PY - 2019/8

Y1 - 2019/8

N2 - OBJECTIVE: The DanGer Shock trial test the hypothesis that left ventricular (LV) mechanical circulatory support with Impella CP transvalvular microaxial flow pump improves survival in patients with ST segment elevation acute myocardial infarction complicated by cardiogenic shock (AMICS) compared to conventional guideline-driven treatment. This paper describes the rationale and design of the randomized trial, in addition to the baseline characteristics of the population screened and enrolled so far.METHODS: The DanGer Shock study is a prospective, multicenter, open-label trial in patients with AMICS randomized 1:1 to Impella CP or current guideline-driven therapy with planned enrollment of 360 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive Impella CP, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days. Baseline characteristics of patients screened and randomized in the DanGer Shock as of June 2018 are compared with 2 contemporary AMICS studies.RESULTS: As of end of June 2018, 314 patients were screened and 100 patients were randomized. Patients had median arterial lactate of 5.5 mmol/L (interquartile range 3.7-8.8 mmol/L), median systolic blood pressure of 76 mmHg (interquartile range 70-88 mmHg), and median LV ejection fraction of 20% (interquartile range 10%-30%).CONCLUSION: The DanGer Shock trial will be the first adequately powered randomized trial to address whether mechanical circulatory LV support with Impella CP can improve survival in AMICS. Baseline characteristics of the first 100 randomized patients indicate a population in profound cardiogenic shock.

AB - OBJECTIVE: The DanGer Shock trial test the hypothesis that left ventricular (LV) mechanical circulatory support with Impella CP transvalvular microaxial flow pump improves survival in patients with ST segment elevation acute myocardial infarction complicated by cardiogenic shock (AMICS) compared to conventional guideline-driven treatment. This paper describes the rationale and design of the randomized trial, in addition to the baseline characteristics of the population screened and enrolled so far.METHODS: The DanGer Shock study is a prospective, multicenter, open-label trial in patients with AMICS randomized 1:1 to Impella CP or current guideline-driven therapy with planned enrollment of 360 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive Impella CP, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days. Baseline characteristics of patients screened and randomized in the DanGer Shock as of June 2018 are compared with 2 contemporary AMICS studies.RESULTS: As of end of June 2018, 314 patients were screened and 100 patients were randomized. Patients had median arterial lactate of 5.5 mmol/L (interquartile range 3.7-8.8 mmol/L), median systolic blood pressure of 76 mmHg (interquartile range 70-88 mmHg), and median LV ejection fraction of 20% (interquartile range 10%-30%).CONCLUSION: The DanGer Shock trial will be the first adequately powered randomized trial to address whether mechanical circulatory LV support with Impella CP can improve survival in AMICS. Baseline characteristics of the first 100 randomized patients indicate a population in profound cardiogenic shock.

KW - Aged

KW - Blood Pressure

KW - Cause of Death

KW - Female

KW - Guideline Adherence

KW - Heart-Assist Devices

KW - Humans

KW - Lactic Acid/blood

KW - Male

KW - Middle Aged

KW - Patient Selection

KW - Percutaneous Coronary Intervention

KW - Prospective Studies

KW - Research Design

KW - ST Elevation Myocardial Infarction/blood

KW - Shock, Cardiogenic/blood

KW - Stroke Volume

KW - Time Factors

U2 - 10.1016/j.ahj.2019.04.019

DO - 10.1016/j.ahj.2019.04.019

M3 - Journal article

C2 - 31176289

VL - 214

SP - 60

EP - 68

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -