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Randomized Controlled Trial
. 2025 Apr 29;85(16):1587-1597.
doi: 10.1016/j.jacc.2025.03.003. Epub 2025 Mar 30.

Early Intra-Aortic Balloon Support for Heart Failure-Related Cardiogenic Shock: A Randomized Clinical Trial

Nuccia Morici  1 , Alice Sacco  2 , Simone Frea  3 , Matteo Rota  4 , Luca Villanova  2 , Carol Gravinese  3 , Carlotta Sorini Dini  5 , Nicoletta D'Ettore  6 , Giulia Maj  6 , Giulia De Lio  3 , Luciano Potena  7 , Serafina Valente  5 , Mario Sabatino  7 , Giovanna Viola  2 , Laura Garatti  2 , Giovanni Amedeo Tavecchia  2 , Letizia Bertoldi  8 , Fabrizio Oliva  2 , Navin K Kapur  9 , Guido Tavazzi  10 , Gaetano Maria De Ferrari  3 , Federico Pappalardo  11 ; Altshock-2 Investigators
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Free article
Randomized Controlled Trial

Early Intra-Aortic Balloon Support for Heart Failure-Related Cardiogenic Shock: A Randomized Clinical Trial

Nuccia Morici et al. J Am Coll Cardiol. .
Free article

Abstract

Background: The impact of intra-aortic balloon pump (IABP) on survival and successful bridging to heart replacement therapies (HRT) in patients with heart failure-cardiogenic shock (HF-CS) remains unclear.

Objectives: The purpose of this study was to evaluate the effect of early IABP use vs standard care on 60-day survival or successful bridging to HRT.

Methods: In the multicenter, prospective Altshock-2 (Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock), patients with Society for Cardiovascular Angiography and Interventions stage B, C, or D HF-CS and suitable for HRT were randomized to receive early IABP plus standard care (IABP group) or standard care (control group). The primary endpoint was survival or successful bridge to HRT at 60 days. Secondary endpoints included overall survival, maximum inotropic score, and maximum sequential organ failure assessment score.

Results: In total, 53 patients were randomized to IABP and 48 to standard care. Patients were Society for Cardiovascular Angiography and Interventions stage B (28%, n = 28), C (57%, n = 56), and D (15%, n = 16). At the prespecified interim analysis, the trial was stopped because of futility. The primary endpoint was reached in 43 patients (81%) in the IABP group and 36 patients (75%) in the control group (HR: 0.72; 95% CI: 0.31-1.68; P = 0.45). A total of 37 patients (37%) underwent HRT within the 60-day follow-up. Four patients were escalated in the study group (7.5%) vs 2 in the control group (4.2%). Additionally, 6 patients (13%) initially assigned to standard care crossed over to IABP. Complications were comparable between groups.

Conclusions: Routine early IABP plus standard care, compared with standard care, did not significantly improve survival or successful bridging to HRT in patients with HF-CS. (Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock [Altshock-2]; NCT04369573).

Keywords: heart failure-cardiogenic shock; heart replacement therapies; intra-aortic balloon pump.

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Conflict of interest statement

Funding Support and Author Disclosures The trial was supported by an unrestricted grant provided by Getinge Global US. Representatives of the funders did not take part in the trial design and did not participate in the analysis or interpretation of data or in the writing of the paper. Dr Kapur has been appointed as Global Chief Medical and scientific officer at Johnson and Johnson MedTech, Heart Recovery; has received institutional research grants from Abbott, Abiomed, Boston Scientific, Getinge, LivaNova, and Teleflex; and has received consulting/speaking honoraria from Abbott, Abiomed, Boston Scientific, Getinge, LivaNova, Teleflex, Zoll, and Edwards. Dr Pappalardo is a consultant for Abiomed and Carmat. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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