DanGer Shock RCT
DanGer Shock Randomized Controlled Trial (RCT) Confirms Routine Use of Impella® Improves Survival in AMICS due to STEMI1
This independent investigator-initiated study is the first RCT of Impella in cardiogenic shock to complete enrollment. It assessed the efficacy of Impella CP® heart pumps in treating patients with AMICS shock due to STEMI, undergoing emergency PCI.
The New England Journal of Medicine RCT assessed the efficacy of Impella CP® heart pumps in treating patients with AMICS due to STEMI, undergoing emergency PCI.
- Overall 26% relative risk reduction, 12.7% absolute risk reduction, NNT:8 * (p=0.04)
- Patients <77 years: 35.7% relative risk reduction, 20% absolute risk reduction, NNT: 5 (p=0.0001)2
- Impella CP promotes faster lactate clearance and reduces dependency on vasoactive drugs, improving patient outcomes3
- Adverse events in DanGer Shock were transient: Patients with bleeding are severely ill, but bleeding itself did not affect overall mortality, no patients required dialysis at six months, and outcomes can be further optimized with best practices and technologies4,5,6
Routine Impella CP Use Reduces 180-Day All-Cause Mortality in AMICS Due to STEMI1
The DanGer Shock RCT confirms Impella CP® improves survival by 12.7%, compared to the control arm treated without Impella heart pumps, in heart attack with shock at 180 days.1 This independent investigator-initiated study represents a landmark as:
- The first RCT in AMICS trial history to achieve its primary endpoint.1
- The first RCT in the MCS device trial history to demonstrate a survival benefit in AMICS.1
Additional Subgroup Analyses and an Update From TCT 2024
- Relative mortality reduction of 35.7% and absolute mortality reduction of 20% with an NNT 5 for patients less than 77 years.2
- Impella CP promotes faster lactate clearance and reduces dependency on vasoactive drugs, improving patient outcomes.3
- Patients with bleeding are severely ill, but bleeding itself did not affect overall mortality.4
- Impella CP improved outcomes in all categories of CRRT/AKI and no surviving patients required dialysis at six months.5
Patients Randomized 1:1
Inclusion Criteria
STEMI
ST-elevation of the J-point in two contiguous ECG leads ≥0.2 mV in men, or ≥0.15 mV in woman in leads V2-V3, or >0.1 mV in other leads for both genders. In addition patients presenting with STEMI equivalent according to ESC guidelines 2017 with presumed new proximal occlusion of a coronary artery are also a candidate for inclusion.
Cardiogenic Shock
A. Peripheral sign of tissue hypoperfusion with arterial blood lactate ≥2.5 mmol/L and/or SvO2 < 55%7,
B. Persistent (>30 min) systolic blood pressure less than 100 mmHg and/or need for vasoactive therapy and
C. Left ventricular ejection fraction of less than 45% on echocardiography.
Timing
Patients were enrolled at presentation to catheterization laboratory before PCI and up to 12 hours after intervention.
Exclusion Criteria
- Shock duration >24 hours
- Other causes of shock; hypovolemia, sepsis, pulmonary embolism or anaphylaxis
- Shock due to mechanical complication of myocardial infarction; papillary muscle rupture, rupture of the ventricular septum or rupture of ventricular free wall.
- Severe aortic valve regurgitation/stenosis
- Severe peripheral arterial obstructive disease that would preclude Impella device placement
- Mechanical aortic valve prosthesis
- Already established mechanical circulatory support (Impella or VA-ECMO)
- Left ventricular thrombus
- Infective endocarditis
- Shock due to right ventricular failure
- Out of hospital cardiac arrest with persistent Glasgow coma scale <8 after return of spontaneous circulation. Cardiac arrest occurring in ambulance or after arrival to hospital is not an exclusion criterion.
- Subject with documented heparin induced thrombocytopenia.
- Life expectancy of less than one year due to comorbidities.
- Mental disorder or language barrier that preclude informed consent.
Other important safety information can be found at https://www.abiomed.com/important-safety-information
References
- Møller, J., et al. (2024). Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med. 390(15), 1382-1393.
- Klein, A., et al. DanGer Shock Investigators (2024). Treating Older Patients in Cardiogenic Shock with a Microaxial Flow Pump: Is it DANGERous?. Journal of the American College of Cardiology, S0735-1097(24)10416-0. Advance online publication. https://doi.org/10.1016/j.jacc.2024.11.003
- Udesen NLJ, et al. (2024). Microaxial Flow Pump Hemodynamic and Metabolic Effects in Infarct-Related Cardiogenic Shock: A Substudy of the DanGer Shock Randomized Clinical Trial. JAMA Cardiol. doi:10.1001/jamacardio.2024.4197
- Holmvang, Lene. Impact of Bleeding Complications on Clinical Outcomes in Patients Undergoing Impella Support in Cardiogenic Shock [abstract]. In: Transcatheter Cardiovascular Therapeutics (TCT) Conference; 2024 October 27-30; Washington DC.
- Zweck, E, et al. (2024). Microaxial Flow Pump Use and Renal Outcomes in Infarct-Related Cardiogenic Shock – A Secondary Analysis of the DanGer Shock Trial. Circulation. https://doi.org/10.1161/CIRCULATIONAHA.124.072370
- Basir, B., et al. (2023). Early Utilization of Mechanical Circulatory Support in Acute Myocardial Infarction Complicated by Cardiogenic Shock: The National Cardiogenic Shock Initiative. J Am Heart Assoc. 12(23). doi:10.1161/JAHA.123.031401
- Møller JE, Engstrøm T, Jensen LO, et al. (2024). Microaxial flow pump or standard care in infarct-related cardiogenic shock. N Engl J Med. DOI: 10.1056/NEJMoa2312572
NPS-4323