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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

Guillaume Lamirault 1, 2 Elodie de Bock 3 Véronique Sébille 4, 3 Béatrice Delasalle 2 Jérôme Roncalli 5, 6 Sophie Susen 7 Christophe Piot 8 Jean-Noël Trochu 2, 1 Emmanuel Teiger 9 Yannick Neuder 10 Thierry Le Tourneau 2, 1 Alain Manrique 11 Jean-Benoît Hardouin 3, 4 Patricia Lemarchand 2, 1, *
* Corresponding author
1 CIC Nantes - Centre d’Investigation Clinique de Nantes
2 ITX - unité de recherche de l'institut du thorax UMR1087 UMR6291
3 Biostatistique, Pharmacoépidémiologie et Mesures Subjectives en Santé
4 Plateforme de Biométrie [Nantes]
5 Service de cardiologie [Toulouse]
6 I2MC - Institut des Maladies Métaboliques et Cardiovasculaires
7 Laboratoire d'Hématologie
8 Cardiologie interventionnelle [Montpellier]
9 CIC Henri Mondor - Centre d'Investigation Clinique Henri Mondor
10 Pôle Thorax et Vaisseaux [CHU Grenoble]
11 SEILIRM - Signalisation, électrophysiologie et imagerie des lésions d’ischémie-reperfusion myocardique
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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Submitted on : Monday, August 1, 2016 - 2:26:43 PM
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Guillaume Lamirault, Elodie de Bock, Véronique Sébille, Béatrice Delasalle, Jérôme Roncalli, 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. Quality of Life Research, Springer Verlag, 2017, 26 (1), pp.121-125. ⟨10.1007/s11136-016-1366-7⟩. ⟨inserm-01350712⟩

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