Table 4. Randomized Controlled GCSF Trials* in Patients With Acute MI.
Valgimigli et al. (58) |
Ince et al. (56) FIRSTLINE-AMI |
Ripa et al. (60) STEMMI |
Zohlnhöfer et al. (61) REVIVAL-2 |
Engelmann et al. (59) G-CSF-STEMI |
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Treatment Group | GCSF | Control | GCSF | Control† | GCSF | Control | GCSF | Control | GCSF | Control |
GCSF dosage | 5 /μg/kg/day for 4 days beginning 37 ± 66 h after symptom onset |
10 /μg/kg/day for 6 days beginning 85 ± 30 min after reperfusion |
10 /μg/kg/day for 6 days beginning 1–2 days after AMI |
10 /μg/kg/day for 5 days beginning 5 days after AMI |
10 /μg/kg/day for 5 days beginning 6 h to 7 days after symptom onset |
|||||
Duration of follow-up | 6 months | 4 months | 6 months | 4–6 months | 3 months | |||||
n | 10 | 10 | 25 | 25 | 39 | 39 | 56 | 58 | 23 | 21 |
LVEF | Increased | Increased | Increased | Unchanged | Increased | Increased | Increased | Increased | Increased | Increased |
Perfusion | Increased | Increased | NR | NR | NR | NR | Increased‡ | Increased‡ | Unchanged | Unchanged |
LVEDV | Unchanged | Unchanged | Unchanged | Declined | Increased | Increased | Decreased | Decreased | Increased | Increased |
LVESV | NR | NR | NR | NR | Decreased | Decreased | Decreased | Decreased | Decreased | Decreased |
Wall thickening | NR | NR | Increased | Increased | Increased | Increased | NR | NR | Increased | Increased |
Parameters displaying significantly better performance than was observed in the alternative treatment group are identified with bold italicized text. Within-group changes from baseline to follow-up were either insignificant (p > 0.05) or the significance was not reported.
Double-blind: Ripa et al. (60), Zohlnhöfer et al. (61), and Engelmann et al. (59); single-blind: Valgimigli et al. (58); open-label: Ince et al. (56).
No placebo treatment.
Decreased infarct size.
AMI = acute myocardial infarction; GCSF = granulocyte colony-stimulating factor; LVEDV = left ventricular end-diastolic volume; LVEF = left ventricular ejection fraction; LVESV = left ventricular end-systolic volume; NR = not reported.