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.
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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
Original language English
Type of outcome Article in a journal
Field of Study 30201 Cardiac and Cardiovascular systems
Country of publisher United Kingdom of Great Britain and Northern Ireland
Confidentiality degree is not subject to a state or trade secret
WWW 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
Tags 14110211, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 12/1/2021 13:07.
Abstract
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] .
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