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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| Authors: | Guillaume Lamirault Elodie de Bock Véronique Sébille Béatrice Delasalle Jérôme Roncalli Sophie Susen Christophe Piot Jean-Noël Trochu Emmanuel Teiger Yannick Neuder Thierry Le Tourneau Alain Manrique Jean-Benoît Hardouin Patricia Lemarchand |
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| Institution: | 1.INSERM, UMR1087, CNRS, UMR 6291, l’institut du thorax, Clinique cardiologique, CIC-thorax,Université de Nantes, CHU de Nantes,Nantes,France;2.EA4275 SPHERE “bioStatistics, Pharmacoepidemiology and Human sciEnces REsearch”,Université de Nantes,Nantes,France;3.Plateforme méthodologie et biostatistique,CHU de Nantes,Nantes,France;4.INSERM, UMR1087, CNRS, UMR 6291, l’institut du thorax, CIC-thorax,Université de Nantes, CHU de Nantes,Nantes,France;5.Service de Cardiologie A, CIC-Biothérapies, I2MC, INSERM 1048,CHU de Toulouse,Toulouse,France;6.Department of Hematology and Transfusion, Lille University Hospital, EA 2693,Lille-II-University,Lille,France;7.Cardiologie interventionnelle,Clinique du Millénaire,Montpellier,France;8.Assistance Publique-H?pitaux de Paris, Fédération de Cardiologie et Centre d’Investigation Clinique 1430,H?pitaux Universitaires Henri Mondor,Créteil,France;9.Pole Thorax et Vaisseaux,CHU de Grenoble,La Tronche,France;10.EA4650, Department of Imaging, CHU de Caen, GIP CYCERON,Université de Caen Basse-Normandie,Caen,France |
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| Abstract: | PurposeCardiac 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.MethodsIn 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.ResultsUsing 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.ConclusionOur 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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