Abstract 15055: Risk of Adverse Events at 5-years Follow-up after Cell Mobilization with Granulocyte-Colony Stimulating Factor After Acute ST-Elevation Myocardial Infarction
Background: Granulocyte-colony stimulating factor (G-CSF) has been investigated in clinical trials aiming to promote recovery of myocardial function after myocardial infarction. Long-term safety-data has never been reported. A few studies have indicated an increased risk of instent restenosis. We aimed to assess clinical events five years after inclusion into a randomized trial of G-CSF versus placebo.
Methods: Seventy-eight patients were randomized, from 2003 to 2005, to G-CSF (10μg/kg/day for 6 days) or placebo after myocardial infarction. Four patients withdrew consent prior to G-CSF treatment and were excluded. Information about all hospital admittances of included patients until 2010 were retrospectively extracted from a national register. The only censoring event was immigration. The clinical events were combined into 4 prespecified endpoints: Time to first (1) hospital admittance (all cause), (2) cardiovascular related hospital admittance, (3) major cardiovascular event, (4) Death.
Results: Only 1 patient was lost to follow-up due to immigration. Four patients (4%) died in the follow-up period, 3 in the G-CSF group and 1 in the placebo group (p=0.4). Hazard ratio for all cause hospital admittance was 0.7 (95% c.i. 0.38–1.29). The incidence of both new myocardial infarction (p=1.0) and revascularization procedures (0.4) were similar in the two groups. The survival analyses showed no differences in the occurrence of any of the 4 prespecified composit endpoints between the two groups (Figure, p=0.6; 0.5; 0.8; 0.3).
Conclusion: G-CSF therapy is safe after myocardial infarction. We found no indication of increased risk of instent restenosis up to five years after treatment. These results support the continued investigation of G-CSF for cardiac therapy.
- © 2010 by American Heart Association, Inc.