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Randomized Controlled Trial
. 2022 Apr;9(2):1152-1159.
doi: 10.1002/ehf2.13786. Epub 2022 Jan 18.

Five-year follow-up of intracoronary autologous cell therapy in acute myocardial infarction: the REGENERATE-AMI trial

Anthony Mathur  1   2 , Doo Sun Sim  1   3 , Fizzah Choudry  1   2 , Jessry Veerapen  1   2 , Martina Colicchia  2 , Tymoteusz Turlejski  2 , Mohsin Hussain  1   2 , Stephen Hamshere  2 , Didier Locca  1   4 , Roby Rakhit  5 , Tom Crake  2 , Jens Kastrup  6 , Samir Agrawal  7 , Daniel A Jones  1   2 , John Martin  8
Affiliations
Randomized Controlled Trial

Five-year follow-up of intracoronary autologous cell therapy in acute myocardial infarction: the REGENERATE-AMI trial

Anthony Mathur et al. ESC Heart Fail. 2022 Apr.

Abstract

Aims: The long-term outcomes of the intracoronary delivery of autologous bone marrow-derived cells (BMCs) after acute myocardial infarction are not well established. Following the promising 1 year results of the REGENERATE-AMI trial (despite it not achieving its primary endpoint), this paper presents the analysis of the 5 year clinical outcomes of these acute myocardial infarction patients who were treated with an early intracoronary autologous BMC infusion or placebo.

Methods and results: A 5 year follow-up of major adverse cardiac events (defined as the composite of all-cause death, recurrent myocardial infarction, and all coronary revascularization) and of rehospitalization for heart failure was completed in 85 patients (BMC n = 46 and placebo n = 39). The incidence of major adverse cardiac events was similar between the BMC-treated patients and the placebo group (26.1% vs. 18.0%, P = 0.41). There were no cases of cardiac death in either group, but an increase in non-cardiac death was seen in the BMC group (6.5% vs. 0%, P = 0.11). The rates of recurrent myocardial infarction and repeat revascularization were similar between the two groups. There were no cases of rehospitalization for heart failure in either group.

Conclusion: This 5 year follow-up analysis of the REGENERATE-AMI trial did not show an improvement in clinical outcomes for patients treated with cell therapy. This contrasts with the 1 year results which showed improvements in the surrogate outcome measures of ejection fraction and myocardial salvage index.

Keywords: Myocardial infarction; Percutaneous coronary intervention; Stem cells.

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Conflict of interest statement

None declared.

Figures

Figure 1
Figure 1
Consort diagram.
Figure 2
Figure 2
Kaplan–Meier curves for (A) MACE, (B) all‐cause mortality, (C) recurrent myocardial infarction, and (D) repeat revascularization at 5 years.
See this image and copyright information in PMC

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