The effect of intracoronary infusion of bone marrow-derived
mononuclear cells on all-cause mortality in acute myocardial
infarction: the BAMI trial

J 2020

The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial

MATHUR, A., F. FERNANDEZ-AVILES, J. BARTUNEK, A. BELMANS, F. CREA et. al.

Basic information

Original name

The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial

Authors

MATHUR, A. (guarantor), F. FERNANDEZ-AVILES, J. BARTUNEK, A. BELMANS, F. CREA, S. DOWLUT, M. GALINANES, M. C. GOOD, J. HARTIKAINEN, C. HAUSKELLER, S. JANSSENS, Petr KALA (203 Czech Republic, belonging to the institution), J. KASTRUP, J. MARTIN, P. MENASCHE, R. SANZ-RUIZ, S. YLA-HERTTUALA and A. ZEIHER

Edition

European heart journal, Oxford, Oxford University Press, 2020, 0195-668X

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 29.983

RIV identification code

RIV/00216224:14110/20:00117708

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1093/eurheartj/ehaa651

UT WoS

000593017200010

Keywords in English

ST-elevation myocardial infarction; Cell- and tissue-based therapy; Bone marrow cells

Abstract

V originále

Aims Bone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent. Methods and results Originally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, <45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2-8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0-5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7-12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group. Conclusions Although BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results. [GRAPHICS] .

Citovat

MATHUR, A., F. FERNANDEZ-AVILES, J. BARTUNEK, A. BELMANS, F. CREA, S. DOWLUT, M. GALINANES, M. C. GOOD, J. HARTIKAINEN, C. HAUSKELLER, S. JANSSENS, Petr KALA, J. KASTRUP, J. MARTIN, P. MENASCHE, R. SANZ-RUIZ, S. YLA-HERTTUALA and A. ZEIHER. The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial. European heart journal. Oxford: Oxford University Press, 2020, vol. 41, No 38, p. 3702-3710. ISSN 0195-668X. Available from: https://dx.doi.org/10.1093/eurheartj/ehaa651.

@article{1726205,
   author = {Mathur, A. and FernandezandAviles, F. and Bartunek, J. and Belmans, A. and Crea, F. and Dowlut, S. and Galinanes, M. and Good, M. C. and Hartikainen, J. and Hauskeller, C. and Janssens, S. and Kala, Petr and Kastrup, J. and Martin, J. and Menasche, P. and SanzandRuiz, R. and YlaandHerttuala, S. and Zeiher, A.},
   article_location = {Oxford},
   article_number = {38},
   doi = {http://dx.doi.org/10.1093/eurheartj/ehaa651},
   keywords = {ST-elevation myocardial infarction; Cell- and tissue-based therapy; Bone marrow cells},
   language = {eng},
   issn = {0195-668X},
   journal = {European heart journal},
   title = {The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial},
   url = {https://watermark.silverchair.com/ehaa651.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAtowggLWBgkqhkiG9w0BBwagggLHMIICwwIBADCCArwGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMDy2VyrZlWWSysS8wAgEQgIICjf12t8DWBHBExxXmCAdSqIQrDNtwQdhGB6FEhxpj6coL8l},
   volume = {41},
   year = {2020}
}

TY  - JOUR
ID  - 1726205
AU  - Mathur, A. - Fernandez-Aviles, F. - Bartunek, J. - Belmans, A. - Crea, F. - Dowlut, S. - Galinanes, M. - Good, M. C. - Hartikainen, J. - Hauskeller, C. - Janssens, S. - Kala, Petr - Kastrup, J. - Martin, J. - Menasche, P. - Sanz-Ruiz, R. - Yla-Herttuala, S. - Zeiher, A.
PY  - 2020
TI  - The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial
JF  - European heart journal
VL  - 41
IS  - 38
SP  - 3702-3710
EP  - 3702-3710
PB  - Oxford University Press
SN  - 0195668X
KW  - ST-elevation myocardial infarction
KW  - Cell- and tissue-based therapy
KW  - Bone marrow cells
UR  - https://watermark.silverchair.com/ehaa651.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAtowggLWBgkqhkiG9w0BBwagggLHMIICwwIBADCCArwGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMDy2VyrZlWWSysS8wAgEQgIICjf12t8DWBHBExxXmCAdSqIQrDNtwQdhGB6FEhxpj6coL8l
L2  - https://watermark.silverchair.com/ehaa651.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAtowggLWBgkqhkiG9w0BBwagggLHMIICwwIBADCCArwGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMDy2VyrZlWWSysS8wAgEQgIICjf12t8DWBHBExxXmCAdSqIQrDNtwQdhGB6FEhxpj6coL8l
N2  - Aims Bone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent. Methods and results Originally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, <45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2-8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0-5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7-12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group. Conclusions Although BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results. [GRAPHICS] .
ER  -

MATHUR, A., F. FERNANDEZ-AVILES, J. BARTUNEK, A. BELMANS, F. CREA, S. DOWLUT, M. GALINANES, M. C. GOOD, J. HARTIKAINEN, C. HAUSKELLER, S. JANSSENS, Petr KALA, J. KASTRUP, J. MARTIN, P. MENASCHE, R. SANZ-RUIZ, S. YLA-HERTTUALA and A. ZEIHER. The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial. \textit{European heart journal}. Oxford: Oxford University Press, 2020, vol.~41, No~38, p.~3702-3710. ISSN~0195-668X. Available from: https://dx.doi.org/10.1093/eurheartj/ehaa651.

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