Study on Early Intra-Aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock - Altshock-2

Mar 30, 2025
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Author/Summarized by Author:
Sugi Min, MD
Summary Reviewer:
Fred M. Kusumoto, MD, FACC; Saraschandra Vallabhajosyula, MBBS, FACC
Trial Sponsor:
Getinge Global US
Date Presented:
03/30/2025
Date Published:
03/30/2025
Date Updated:
03/30/2025
Original Posted Date:
03/28/2025
References

Contribution To Literature:

The Altshock-2 trial showed that routine early IABP plus standard care, vs. standard care only, did not significantly improve 60-day survival or successful bridging to HRT in patients with HF-CS.

Description:

The goal of the trial was to evaluate the effect of early intra-aortic balloon pump (IABP) use vs. standard care on 60-day survival or successful bridging to heart replacement therapies (HRT) in patients with heart failure–cardiogenic shock (HF-CS).

Study Design

Patients at seven centers across Italy with Society for Cardiovascular Angiography and Interventions (SCAI) stage B, C, or D HF-CS and suitable for HRT were randomized to receive early IABP plus standard care (IABP group; n=53) or standard care (control group; n=48). At the prespecified interim analysis, the trial was stopped by the Data Safety and Monitoring Board because of futility.

  • Total number of enrollees: 101
  • Duration of follow-up: 60 days
  • Median patient age: 60 years
  • Percentage female: 20%
  • SCAI stage B, 20%; stage C, 57%; stage D, 15%
  • Heart transplant, 18%; LVAD, 19%

Inclusion criteria:

  • Patients aged 18-75 years
  • Had hypotension or hypoperfusion according to standard CS definition
  • SCAI stage B, C, or D HF-CS
  • Left ventricular ejection fraction ≤35%

Exclusion criteria:

  • Septic shock with evident septic focus
  • Severe peripheral vascular disease
  • CS secondary to cardiac and noncardiac surgery
  • Acute myocardial infarction within 1 month
  • Suspected or documented myocarditis
  • Pulmonary embolism
  • Not eligible for HRT
  • Ominous prognosis (life expectancy <1 year)
  • Pregnant or lactating women 

Principal Findings:

Primary outcome: There was no significant difference in the primary endpoint, 60-day survival or successful bridge to HRT, for the early use of IABP in HF-CS patients compared to standard care with vasoactive medications (hazard ratio [HR], 0.72; 95% CI, 0.31-1.68; p=0.45) in the intention-to-treat analysis. Similarly, the per-protocol analysis, which included the six patients who crossed-over to IABP therapy after randomization, did not yield any significant difference in the primary outcome (HR, 0.99; 95% CI, 0.42-2.31; p>0.9).

Secondary outcomes:

No statistically significant differences were observed in the secondary endpoints:

  • Maximum inotropic score: 5.0 in the standard care group vs. 5.0 in the IABP group (p=0.98)
  • Duration of inotropic therapy: 13 hours in the standard care group vs. 13 hours in the IABP group (p=0.82)
  • Maximum sequential organ failure assessment (SOFA) score: 7.00 in the standard care group vs. 6.00 in the IABP group (p=0.18)

Bleeding (17% vs. 8.3%; p=0.19), vascular complications (7.5% vs. 0%; p=0.12), and limb ischemia (3.8% vs. 0%; p=0.50) complications were comparable between the two groups.

Interpretation:

In HF-CS, early afterload reduction and modest cardiac output augmentation with IABP was hypothesized to favorably improve the hemodynamic profile compared to acute myocardial infarction. The Altshock-2 trial demonstrates no benefit in survival or successful bridge to HRT with early initiation of IABP therapy among patients presenting with SCAI-Cardiogenic Shock Working Group stages B-D CS. The higher-than-expected survival in the overall population likely emanates from greater adoption of best practices in CS management, but also selection of patients who were eligible for HRT pre-randomization, which might have contributed to the neutral signal in this trial.

It is important to note that the generalizability of this trial may be limited due to low severity of illness (maximum median inotrope score, 5) and given nearly 90% of screened patients were excluded. Lastly, lack of protocoled IABP management and low use of pulmonary artery catheterization (~40%) in both arms suggest potential opportunities to improve care delivery in HF-CS.

In summary, this study adds to the existing body of literature which does not support the routine use of IABP in CS, but the favorable safety profile of IABP compared to other temporary mechanical circulatory support options makes it a feasible and important option among patients who fail initial inotropic therapy.

References:

Morici N, Sacco A, Frea S, et al., and the Altshock-2 Investigators. Early Intra-Aortic Balloon Support for Heart Failure-Related Cardiogenic Shock: A Randomized Clinical Trial. J Am Coll Cardiol 2025;Mar 30:[Epub ahead of print].

Editorial Comment: Delmas C, Cherbi M, Roubille F, Vandenbriele C. Bursting the Balloon: The End of Intra-Aortic Balloon Pumps for Cardiogenic Shock? J Am Coll Cardiol 2025;Mar 30:[Epub ahead of print].

Editorial Comment: Proudfoot AG, Møller JE, Petrie MC, Samsky MD. Improving Evidence in Cardiogenic Shock: Why Bigger, Bolder Trials are Needed. J Am Coll Cardiol 2025;Mar 30:[Epub ahead of print].

Presented by Dr. Alice Sacco at the American College of Cardiology Annual Scientific Session (ACC.25), Chicago, IL, March 30, 2025.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Acute Heart Failure, Mechanical Circulatory Support

Keywords: ACC25, ACC Annual Scientific Session, Intra-Aortic Balloon Pumping, Shock, Cardiogenic


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