DanGer Shock (original research)
Trial question
What is the role of microaxial flow pump in patients with STEMI-induced cardiogenic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 355
355 patients (74 female, 281 male).
Inclusion criteria: patients with STEMI-induced cardiogenic shock.
Key exclusion criteria: overt RV failure; resuscitation from out-of-hospital cardiac arrest and comatose on arrival to the cardiac catheterization laboratory.
Interventions
N=179 microaxial flow pump (treatment with a catheter-based percutaneous transvalvular microaxial flow pump [Impella CP®] plus standard care).
N=176 standard care (standard care alone).
Primary outcome
Death from any cause at day 180
45.8%
58.5%
58.5 %
43.9 %
29.3 %
14.6 %
0.0 %
Microaxial flow
pump
Standard
care
Significant
decrease ▼
NNT = 7
Significant decrease in death from any cause at day 180 (45.8% vs. 58.5%; HR 0.74, 95% CI 0.55 to 0.99).
Secondary outcomes
Significant decrease in composite end-point of escalation of treatment to additional mechanical circulatory support, heart transplantation, or death from any cause (52.5% vs. 63.6%; HR 0.72, 95% CI 0.55 to 0.95).
No significant difference in the number of days alive and out of hospital (82 days vs. 73 days; AD 8 days, 95% CI -8 to 25).
Safety outcomes
No significant difference in stroke.
Significant differences in severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation (24.0% vs. 6.2%).
Conclusion
In patients with STEMI-induced cardiogenic shock, microaxial flow pump was superior to standard care with respect to death from any cause at day 180.
Reference
Jacob E Møller, Thomas Engstrøm, Lisette O Jensen et al. Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med. 2024 Apr 18;390(15):1382-1393.
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