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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@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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