Key result
Intracoronary mononuclear cell infusion does not increase ventricular arrhythmias or severe arrhythmogenic events vs control.
Why the study?
Does intracoronary infusion of mononuclear cells increase ventricular arrhythmias or severe arrhythmogenic events in patients with PCI-treated myocardial infarction?
RCT (n=164)
Open-label with blinded analysis
1:1:1
Yes
Does intracoronary infusion of mononuclear cells increase ventricular arrhythmias or severe arrhythmogenic events in patients with PCI-treated myocardial infarction?
Intracoronary cell therapy with bone marrow or peripheral blood mononuclear cells does not increase the risk of ventricular arrhythmias or severe arrhythmogenic events in patients with PCI-treated myocardial infarction.
Answers are grounded in this paper and cite their sources.
Intracoronary BMMC/PBMC therapy post-MI shows no increase in ventricular arrhythmias or SAE; extends short-term safety data but leaves open long-term remodeling effects.
To reduce long-term morbidity after revascularised acute myocardial infarction, different therapeutic strategies have been investigated. Cell therapy with mononuclear cells from bone marrow (BMMC) or peripheral blood (PBMC) has been proposed to attenuate the adverse processes of remodelling and subsequent heart failure. Previous trials have suggested that cell therapy may facilitate arrhythmogenesis. In the present substudy of the HEBE cell therapy trial, we investigated whether intracoronary cell therapy alters the prevalence of ventricular arrhythmias after 1 month or the rate of severe arrhythmogenic events (SAE) in the first year. In 164 patients of the trial we measured function and infarct size with cardiovascular magnetic resonance (CMR) imaging. Holter registration was performed after 1 month from which the number of triplets (3 successive PVCs) and ventricular tachycardias (VT, ≥4 successive PVCs) was assessed. Thirty-three patients (20%) showed triplets and/or VTs, with similar distribution amongst the groups (triplets: control n = 8 vs. BMMC n = 9, p = 1.00; vs. PBMC n = 10, p = 0.67. VT: control n = 9 vs. BMMC n = 9, p = 0.80; vs. PBMC n = 11, p = 0.69). SAE occurred in 2 patients in the PBMC group and 1 patient in the control group. In conclusion, intracoronary cell therapy is not associated with an increase in ventricular arrhythmias or SAE.
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Robbers et al. (2012) conducted an RCT in Acute myocardial infarction (STEMI) (n=164). Intracoronary infusion of mononuclear cells (BMMC or PBMC) vs. Standard medical therapy was evaluated on Ventricular tachycardias (>4 PVCs) at 1 month (BMMC vs Control) (p=0.80). Intracoronary infusion of mononuclear cells from bone marrow or peripheral blood did not significantly increase the prevalence of ventricular arrhythmias at 1 month or severe arrhythmogenic events at 1 year compared to standard therapy.
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