Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial.
OBJECTIVE
Intracoronary administration of autologous bone marrow cells (BMCs) leads to a modest improvement in cardiac function, but the effect on myocardial viability is unknown. The aim of this randomized multicentre study was to evaluate the effect of BMC therapy on myocardial viability in patients with decreased left ventricular ejection fraction (LVEF) after acute myocardial infarction (AMI) and to identify predictive factors for improvement of myocardial viability.


RESULTS
One hundred and one patients with AMI and successful reperfusion, LVEF ≤45%, and decreased myocardial viability (resting Tl201-SPECT) were randomized to either a control group (n = 49) or a BMC group (n = 52). Primary endpoint was improvement of myocardial viability 3 months after AMI. Baseline mean LVEF measured by radionuclide angiography was 36.3 ± 6.9%. Bone marrow cell infusion was performed 9.3 ± 1.7 days after AMI. Myocardial viability improved in 16/47 (34%) patients in the BMC group compared with 7/43 (16%) in the control group (P = 0.06). The number of non-viable segments becoming viable was 0.8 ± 1.1 in the control group and 1.2 ± 1.5 in the BMC group (P = 0.13). Multivariate analysis including major post-AMI prognostic factors showed a significant improvement of myocardial viability in BMC vs. control group (P = 0.03). Moreover, a significant adverse role for active smoking (P = 0.04) and a positive trend for microvascular obstruction (P = 0.07) were observed.


CONCLUSIONS
Intracoronary autologous BMC administration to patients with decreased LVEF after AMI was associated with improvement of myocardial viability in multivariate-but not in univariate-analysis. A large multicentre international trial is warranted to further document the efficacy of cardiac cell therapy and better define a group of patients that will benefit from this therapy.


BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier NCT00200707.
Fédération de Cardiologie, CHU Toulouse, INSERM U858, Institut de Médecine Moléculaire de Rangueil, Université Paul Sabatier, Toulouse, France.
Jérôme
J
Roncalli
Frédéric
F
Mouquet
Christophe
C
Piot
Jean-Noel
JN
Trochu
Philippe
P
Le Corvoisier
Yannick
Y
Neuder
Thierry
T
Le Tourneau
Denis
D
Agostini
Virginia
V
Gaxotte
Catherine
C
Sportouch
Michel
M
Galinier
Dominique
D
Crochet
Emmanuel
E
Teiger
Marie-Jeanne
MJ
Richard
Anne-Sophie
AS
Polge
Jean-Paul
JP
Beregi
Alain
A
Manrique
Didier
D
Carrie
Sophie
S
Susen
Bernard
B
Klein
Angelo
A
Parini
Guillaume
G
Lamirault
Pierre
P
Croisille
Hélène
H
Rouard
Philippe
P
Bourin
Jean-Michel
JM
Nguyen
Béatrice
B
Delasalle
Gérald
G
Vanzetto
Eric
E
Van Belle
Patricia
P
Lemarchand
D000293:Adolescent; D000328:Adult; D000368:Aged; D016026:Bone Marrow Transplantation / Q000379:methods*; D017023:Coronary Angiography; D003331:Coronary Vessels; D005260:Female; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000637:transplantation*; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D013318:Stroke Volume / Q000502:physiology; D015899:Tomography, Emission-Computed, Single-Photon; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000473:pathology / Q000503:physiopathology; D055815:Young Adult