title: Clinical outcome after stem cell mobilization with granulocyte-colony-stimulating factor after acute ST-elevation myocardial infarction: 5-year results of the STEMMI trial.
abstract: BACKGROUND
  Granulocyte-colony-stimulating factor (G-CSF) has been investigated in trials aiming to promote recovery of myocardial function after myocardial infarction. Long-term safety-data have never been reported. A few studies indicated an increased risk of in-stent re-stenosis. We aimed to investigate clinical events 5 years after inclusion into a randomized trial of G-CSF versus placebo.
  
  
  METHODS
  Seventy-eight patients were randomized, from 2003-2005, to G-CSF or placebo after myocardial infarction. Four patients withdrew consent prior to study treatment and were excluded leaving 36 and 38 in the placebo- and G-CSF groups. Information about all hospital admittances of included patients until 2010 was extracted from a national register. The only censoring event was immigration. The events were combined into four prespecified endpoints: Time to (1) first hospital admittance (all cause), (2) first cardiovascular-related hospital admittance, (3) first major cardiovascular event, and (4) death.
  
  
  RESULTS
  One patient (1%) was lost to follow-up. Four patients (4%) died in the follow-up period, three in the G-CSF group and one in the placebo group (p = 0.4). Hazard ratio for all cause hospital admittance was 0.7 (95% CI 0.38-1.29). The incidence of both new myocardial infarction (p = 1.0) and revascularization procedures (p = 0.4) were similar in the two groups. Survival analyses showed no differences in the occurrence of any of the four prespecified composite endpoints between the two groups (p = 0.6; 0.5; 0.8; 0.3).
  
  
  CONCLUSIONS
  We found no indication of increased risk of adverse events up to 5 years after G-CSF treatment. These results support the continued investigation of G-CSF for cardiac therapy.
authors.affiliation: Department of Cardiology, Nuclear Medicine and PET, Copenhagen University Hospital, Rigshospitalet, Denmark. ripa@sund.ku.dk
authors.forename: Rasmus S
authors.initials: RS
authors.lastname: Ripa
authors.forename: Erik
authors.initials: E
authors.lastname: Jørgensen
authors.forename: Jens
authors.initials: J
authors.lastname: Kastrup
mesh_terms: D053687:Adult Stem Cells / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006760:Hospitalization; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor