Altshock-2
Trial question
What is the effect of early intra-aortic balloon pump implantation in patients with HF-related cardiogenic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
20.0% female
80.0% male
N = 101
101 patients (20 female, 81 male).
Inclusion criteria: patients with HF-related cardiogenic shock and suitable for heart replacement therapies.
Key exclusion criteria: septic shock with evident septic focus; acute coronary syndrome; acute myocarditis; PE; peripheral vasculopathy; age > 75 years; ejection fraction > 35%; life expectancy < 1 year.
Interventions
N=53 early intra-aortic balloon pump implantation (intra-aortic balloon pump implantation within 6 hours since cardiogenic shock symptoms onset plus standard care).
N=48 standard of care (standard of care as vasoactive agent).
Primary outcome
Survival or successful bridge to heart replacement therapies at 60 days
81%
75%
81.0 %
60.8 %
40.5 %
20.3 %
0.0 %
Early intra-aortic balloon pump
implantation
Standard of
care
No significant
difference ↔
No significant difference in survival or successful bridge to heart replacement therapies at 60 days (81% vs. 75%; HR 0.72, 95% CI 0.31 to 1.68).
Secondary outcomes
No significant difference in duration of hospitalization (33 days vs. 35 days; AD -2 days, 95% CI -49.62 to 45.62).
No significant difference in maximum SOFA score (6 points vs. 7 points; AD -1 points, 95% CI -2.46 to 0.46).
No significant difference in treatment escalation to venoarterial ECMO (5.7% vs. 2.1%; AD 3.6%, 95% CI -10.14 to 17.34).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with HF-related cardiogenic shock and suitable for heart replacement therapies, early intra-aortic balloon pump implantation was not superior to standard of care with respect to survival or successful bridge to heart replacement therapies at 60 days.
Reference
Nuccia Morici, Alice Sacco, Simone Frea et al. Early Intra-Aortic Balloon Support for Heart Failure-Related Cardiogenic Shock: A Randomized Clinical Trial. J Am Coll Cardiol. 2025 Mar 21:S0735-1097(25)05334-3. Online ahead of print.
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