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Sustained quality of life improvement after intracoronary injection of autologous bone marrow cells in the setting of acute myocardial infarction: results from the BONAMI trial

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Abstract

Purpose

Cardiac cell therapy is a promising treatment for acute myocardial infarction (AMI), leading to cardiac function improvement. However, whether it translates into quality of life (QoL) improvement is unclear. We hypothesized that administration of bone marrow cells (BMC) to patients with AMI improves QoL.

Methods

In the multicenter BONAMI trial (NCT00200707), patients with reperfused AMI and decreased myocardial viability were randomized to intracoronary autologous BMC infusion (n = 52) or state-of-the-art therapy (n = 49). QoL data, derived from the Minnesota Living with Heart Failure questionnaire (MLHFQ), were obtained 1, 3, and 12 months after AMI and analyzed using a Rasch-family model.

Results

Using this model, QoL improved over time in the BMC group (p = 0.025) but not in the control group. Furthermore, the BMC-group patients displayed a better QoL than the control-group patients at 3 and 12 months post-AMI (p = 0.034 and p = 0.003, respectively). These findings were not detected when analyzing MLHFQ data using a standard method. Cardiac function, myocardial viability, mortality, and number of major adverse cardiac events did not differ between treatment groups.

Conclusion

Our results suggest that BMC therapy can improve QoL, stressing the need for confirmation trials and for systematic QoL assessment in cardiac cell therapy trials .

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Acknowledgments

The authors thank all hematologists, surgeons, echocardiographers, radiologists, nuclear physicians, and research technicians involved in the study.

Funding

This work was supported in part by a Programme Hospitalier de Recherche Clinique (PHRC) from the French Department of Health, and grants from the Association Française contre les Myopathies and the Fondation de France. There was no relationship with industry.

Author information

Author notes

    Authors and Affiliations

    1. INSERM, UMR1087, CNRS, UMR 6291, l’institut du thorax, Clinique cardiologique, CIC-thorax, Université de Nantes, CHU de Nantes, Nantes, 44000, France

      Guillaume Lamirault, Jean-Noël Trochu & Thierry Le Tourneau

    2. EA4275 SPHERE “bioStatistics, Pharmacoepidemiology and Human sciEnces REsearch”, Université de Nantes, Nantes, France

      Elodie de Bock, Véronique Sébille & Jean-Benoît Hardouin

    3. Plateforme méthodologie et biostatistique, CHU de Nantes, Nantes, France

      Véronique Sébille & Jean-Benoît Hardouin

    4. INSERM, UMR1087, CNRS, UMR 6291, l’institut du thorax, CIC-thorax, Université de Nantes, CHU de Nantes, Nantes, 44000, France

      Béatrice Delasalle & Patricia Lemarchand

    5. Service de Cardiologie A, CIC-Biothérapies, I2MC, INSERM 1048, CHU de Toulouse, Toulouse, France

      Jérôme Roncalli

    6. Department of Hematology and Transfusion, Lille University Hospital, EA 2693, Lille-II-University, Lille, France

      Sophie Susen

    7. Cardiologie interventionnelle, Clinique du Millénaire, 34000, Montpellier, France

      Christophe Piot

    8. Assistance Publique-Hôpitaux de Paris, Fédération de Cardiologie et Centre d’Investigation Clinique 1430, Hôpitaux Universitaires Henri Mondor, 94010, Créteil, France

      Emmanuel Teiger

    9. Pole Thorax et Vaisseaux, CHU de Grenoble, La Tronche, France

      Yannick Neuder

    10. EA4650, Department of Imaging, CHU de Caen, GIP CYCERON, Université de Caen Basse-Normandie, Caen, France

      Alain Manrique

    Authors
    1. Guillaume Lamirault
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    2. Elodie de Bock
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    3. Véronique Sébille
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    4. Béatrice Delasalle
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    5. Jérôme Roncalli
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    6. Sophie Susen
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    7. Christophe Piot
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    8. Jean-Noël Trochu
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    9. Emmanuel Teiger
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    10. Yannick Neuder
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    11. Thierry Le Tourneau
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    12. Alain Manrique
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    13. Jean-Benoît Hardouin
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    14. Patricia Lemarchand
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    Corresponding author

    Correspondence to Patricia Lemarchand.

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    Conflict of interest

    The authors declare that they have no conflict of interest.

    Ethical approval

    All procedures involving human participants performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The ethics review board of Nantes University Hospital approved the protocol. Informed consent: Informed consent was obtained from all individual participants included in the study.

    Additional information

    Guillaume Lamirault, Elodie de Bock and Jean-Benoît Hardouin, Patricia Lemarchand have equally contributed to this work.

    Electronic supplementary material

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    Supplemental data figure 1

    Rates of usable questionnaires for conventional and partial credit model (PCM) methods. Data are shown at one (M1)-, three (M3)-, six (M6)-, and twelve (M12)-month follow-up visits for control (CTL) and bone marrow cell (BMC) groups (TIFF 509 kb)

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    Lamirault, G., de Bock, E., Sébille, V. et al. Sustained quality of life improvement after intracoronary injection of autologous bone marrow cells in the setting of acute myocardial infarction: results from the BONAMI trial. Qual Life Res 26, 121–125 (2017). https://doi.org/10.1007/s11136-016-1366-7

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