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.