title: Stem cell mobilisation by granulocyte-colony stimulating factor in patients with acute myocardial infarction. Long-term results of the REVIVAL-2 trial.
abstract: Treatment with granulocyte-colony stimulating factor (G-CSF) mobilises cells from the bone marrow to the peripheral blood. Previous preclinical and early clinical trials may suggest that treatment with G-CSF leads to improved myocardial perfusion and function in acute or chronic ischaemic heart disease. In the REVIVAL-2 study we found that stem cell mobilisation by G-CSF does not influence infarct size, left ventricular function and coronary restenosis in patients with acute myocardial infarction (MI) that underwent successful percutaneous coronary intervention. The objective of the present analysis was to assess the impact of G-CSF treatment on seven-year clinical outcomes from the REVIVAL-2 trial. In the randomized, double-blind, placebo-controlled REVIVAL-2 study, 114 patients with the diagnosis of acute myocardial infarction were enrolled five days after successful reperfusion by percutaneous coronary intervention. Patients were assigned to receive 10 µg/kg G-CSF (n=56) or placebo (n=58) for five days. The primary endpoint for this long-term outcome analysis was the composite of death, myocardial infarction or stroke seven years after randomisation. The endpoint occurred in 14.3 % of patients in the G-CSF group versus 17.2 % assigned to placebo (p=0.67). The combined incidence of death or myocardial infarction occurred in 14.3 % of the patients assigned to G-CSF and 15.5 % of the patients assigned to placebo (p=0.85). In conclusion, these long-term follow-up data show that G-CSF does not improve clinical outcomes of patients with acute myocardial infarction.
authors.affiliation: B. Steppich, Deutsches Herzzentrum der Technischen Universität München, Lazarettstr. 36, 80636 München Germany, Tel.: +49 89 1218 4014, Fax: +49 89 1218 4006, E-mail: ott@dhm.mhn.de.
authors.forename: Birgit
authors.initials: B
authors.lastname: Steppich
authors.forename: Martin
authors.initials: M
authors.lastname: Hadamitzky
authors.forename: Tareq
authors.initials: T
authors.lastname: Ibrahim
authors.forename: Philip
authors.initials: P
authors.lastname: Groha
authors.forename: Heribert
authors.initials: H
authors.lastname: Schunkert
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Laugwitz
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Ilka
authors.initials: I
authors.lastname: Ott
mesh_terms: D000368:Aged; D001691:Biological Therapy; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D019650:Hematopoietic Stem Cell Mobilization; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000401:mortality / Q000628:therapy*; D062645:Percutaneous Coronary Intervention; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor
keywords: Clinical studies; acute myocardial infarction; cardiology; granulocyte-colony stimulating factor; stem cells