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Granulocyte colony-stimulating factor therapy for stem cell mobilization following anterior wall myocardial
Benjamin Hibbert1, Bradley Hayley1, Robert S Beanlands1
1Division of Cardiology (Hibbert, Hayley, Beanlands, Le May, Davies, So, Marquis, Labinaz, Froeschl, O'Brien, Burwash, Wells, Pourdjabbar, Simard, Glover), Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ont.; Libin Cardiovascular Institute (O'Brien), Calgary, Alta.; Division of Hematology (Atkins), Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Ont.
Insights
Granulocyte colony-stimulating factor (G-CSF) therapy after myocardial infarction did not improve ejection fraction at six months and was associated with a lower ejection fraction compared to placebo. No increased risk of major adverse cardiac events was observed.
Area of Science:
- Cardiology
- Regenerative Medicine
- Clinical Trials
Background:
- Existing research on granulocyte colony-stimulating factor (G-CSF) post-myocardial infarction shows conflicting results.
- A need exists for well-powered studies in patients with significant left ventricular dysfunction.
Purpose of the Study:
- To evaluate the efficacy and safety of G-CSF in patients with left ventricular dysfunction after anterior-wall myocardial infarction.
Main Methods:
- A randomized trial involving 86 patients with ejection fraction <45% post-myocardial infarction.
- Patients received either G-CSF (10 μg/kg daily for 4 days) or placebo.
- Left ventricular ejection fraction was assessed by radionuclide angiography at 6-month follow-up.
Main Results:
- G-CSF therapy did not significantly improve left ventricular ejection fraction at 6 months compared to placebo.
- The change in left ventricular ejection fraction was lower in the G-CSF group (5.7 percentage points) versus the placebo group (9.2 percentage points).
- Rates of major adverse cardiac events and target-vessel revascularization were similar between groups.
Conclusions:
- G-CSF therapy in patients with moderate left ventricular dysfunction post-myocardial infarction was linked to a reduced 6-month ejection fraction.
- G-CSF did not increase the risk of major adverse cardiac events in this patient population.
- Further research on G-CSF in patients with left ventricular dysfunction requires close safety monitoring.
Background:
Small studies have yielded divergent results for administration of granulocyte colony-stimulating factor (G-CSF) after acute myocardial infarction. Adequately powered studies involving patients with at least moderate left ventricular dysfunction are lacking.
Methods:
Patients with left ventricular ejection fraction less than 45% after anterior-wall myocardial infarction were treated with G-CSF (10 μg/kg daily for 4 days) or placebo. After initial randomization of 86 patients, 41 in the placebo group and 39 in the G-CSF group completed 6-month follow-up and underwent measurement of left ventricular ejection fraction by radionuclide angiography.
Results:
Baseline and 6-week mean ejection fraction was similar for the G-CSF and placebo groups: 34.8% (95% confidence interval [CI] 32.6%-37.0%) v. 36.4% (95% CI 33.5%-39.2%) at baseline and 39.8% (95% CI 36.2%-43.4%) v. 43.1% (95% CI 39.2%-47.0%) at 6 weeks. However, G-CSF therapy was associated with a lower ejection fraction at 6 months relative to placebo (40.8% [95% CI 37.4%-44.2%] v. 46.0% [95% CI 42.7%-44.3%]). Both groups had improved left ventricular function, but change in left ventricular ejection fraction was lower in patients treated with G-CSF than in those who received placebo (5.7 [95% CI 3.4-8.1] percentage points v. 9.2 [95% CI 6.3-12.1] percentage points). One or more of a composite of several major adverse cardiac events occurred in 8 patients (19%) within each group, with similar rates of target-vessel revascularization.
Interpretation:
In patients with moderate left ventricular dysfunction following anterior-wall infarction, G-CSF therapy was associated with a lower 6-month left ventricular ejection fraction but no increased risk of major adverse cardiac events. Future studies of G-CSF in patients with left ventricular dysfunction should be monitored closely for safety.
Trial Registration:
ClinicalTrials.gov, no. NCT00394498.
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