dc.contributor.author | Mathur, A | en_US |
dc.contributor.author | Fernández-Avilés, F | en_US |
dc.contributor.author | Bartunek, J | en_US |
dc.contributor.author | Belmans, A | en_US |
dc.contributor.author | Crea, F | en_US |
dc.contributor.author | Dowlut, S | en_US |
dc.contributor.author | Galiñanes, M | en_US |
dc.contributor.author | Good, M-C | en_US |
dc.contributor.author | Hartikainen, J | en_US |
dc.contributor.author | Hauskeller, C | en_US |
dc.contributor.author | Janssens, S | en_US |
dc.contributor.author | Kala, P | en_US |
dc.contributor.author | Kastrup, J | en_US |
dc.contributor.author | Martin, J | en_US |
dc.contributor.author | Menasché, P | en_US |
dc.contributor.author | Sanz-Ruiz, R | en_US |
dc.contributor.author | Ylä-Herttuala, S | en_US |
dc.contributor.author | Zeiher, A | en_US |
dc.contributor.author | BAMI Group | en_US |
dc.date.accessioned | 2020-09-22T15:21:33Z | |
dc.date.available | 2020-07-28 | en_US |
dc.date.issued | 2020-10-07 | en_US |
dc.identifier.uri | https://qmro.qmul.ac.uk/xmlui/handle/123456789/67175 | |
dc.description | This is a pre-copyedited, author-produced version of an article accepted for publication in European Heart Journal, following peer review. The version of record: Anthony Mathur, Francisco Fernández-Avilés, Jozef Bartunek, Ann Belmans, Filippo Crea, Sheik Dowlut, Manuel Galiñanes, Marie-Claire Good, Juha Hartikainen, Christine Hauskeller, Stefan Janssens, Petr Kala, Jens Kastrup, John Martin, Philippe Menasché, Ricardo Sanz-Ruiz, Seppo Ylä-Herttuala, Andreas Zeiher, BAMI Group, 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, ehaa651, https://doi.org/10.1093/eurheartj/ehaa651 is available online at: https://doi.org/10.1093/eurheartj/ehaa651 | en_US |
dc.description.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. | en_US |
dc.format.extent | 3702 - 3710 | en_US |
dc.language | eng | en_US |
dc.relation.ispartof | Eur Heart J | en_US |
dc.subject | Bone marrow cells | en_US |
dc.subject | Cell- and tissue-based therapy | en_US |
dc.subject | ST-elevation myocardial infarction | en_US |
dc.title | The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial. | en_US |
dc.type | Article | |
dc.identifier.doi | 10.1093/eurheartj/ehaa651 | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/32860406 | en_US |
pubs.issue | 38 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published | en_US |
pubs.volume | 41 | en_US |
dcterms.dateAccepted | 2020-07-28 | en_US |
rioxxterms.funder | Default funder | en_US |
rioxxterms.identifier.project | Default project | en_US |