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Updated: Aug 24, 2025
Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Published on: June 12, 2021
Danish-German cardiogenic shock trial-DanGer shock: Trial design update
Jacob Eifer Møller1, Oke Gerke2,
1Department of Cardiology, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Cardiology, the Heart Center, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Insights
The DanGer Shock trial evaluated the Impella CP device for ST-elevation myocardial infarction (STEMI) patients with acute myocardial infarction and cardiogenic shock (AMICS). The study assessed mortality and other key outcomes to determine treatment efficacy.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Acute myocardial infarction and cardiogenic shock (AMICS) is a critical condition with high mortality.
- The Danish German Cardiogenic Shock (DanGer Shock) trial investigates novel treatment strategies.
- Percutaneous coronary intervention (PCI) is a standard treatment for STEMI.
Purpose of the Study:
- To assess the efficacy of the Impella CP transvalvular axial flow device in treating AMICS patients with STEMI undergoing emergency PCI.
- To evaluate the safety and effectiveness of mechanical circulatory support in high-risk cardiac patients.
Main Methods:
- The DanGer Shock trial is a randomized controlled study.
- Statistical analysis will follow a predefined plan, including intention-to-treat and as-treated analyses.
- Primary endpoint is all-cause death at 180 days, analyzed using Cox proportional hazards models.
Main Results:
- The primary endpoint is all-cause mortality at 180 days.
- Secondary endpoints include need for additional mechanical support, cardiac transplantation, and days alive out of hospital.
- Safety endpoints encompass major bleeding, vascular complications, and device-related issues.
Conclusions:
- The main analyses of primary and secondary outcomes will be conducted as per the statistical analysis plan.
- Results will inform clinical practice guidelines for AMICS management.
- The study contributes valuable data on mechanical circulatory support in STEMI-induced cardiogenic shock.
Background:
The main objective of the Danish German Cardiogenic Shock trial (DanGer Shock ClinicalTrials.gov Identifier: NCT01633502) is to assess the efficacy of the trans valvular axial flow device Impella CP in treating patients with AMICS shock due to STEMI undergoing emergency percutaneous coronary intervention.
Methods:
This statistical analysis plan represents an overview of the statistical methods which will be used for analyzing the DanGer Shock trial.
Results:
The primary study endpoint is death from all causes through 180 days in the intention to treat population (all randomized consented patients). The secondary endpoints comprise; composite event of the need for additional mechanical support, need for cardiac transplantation, and death of all causes whichever comes first; and days alive and out of hospital. As exploratory analyses an as treated analysis of primary endpoint will be performed. Composite safety endpoint will comprise of major bleeding, vascular complications, device malfunction, damage to the aortic valve, and significant hemolysis. The primary endpoint death rate at 180 days will be analyzed using Cox proportional hazards analysis. The result will be reported as hazard ratio and corresponding 95% confidence interval (95% CI). No imputation of missing values will be performed. Additional statistical analyses for predefined hemodynamic, metabolic, renal, hematological, and health economics substudies will be specified in separate protocols.
Conclusion:
Main analyses of the primary and secondary outcomes of the DanGer Shock trial will be conducted according to this publication.
