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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. [ABSTRACT FROM AUTHOR]

Background: Plasma YKL-40 is increased early in patients with ST-elevation myocardial infarction (STEMI). It is not known whether plasma YKL-40 is related to infarct size and recovery of ventricular function after primary percutaneous coronary intervention (PCI) of STEMI and whether granulocyte colony-stimulating factor (G-CSF) therapy influence plasma YKL-40 concentration. Materials and methods: A total of 72 patients (age: 56 ± 9 years (mean ± SD), 56 men and 16 women) with STEMI treated with PCI were included in a double-blind, randomized, placebo-controlled trial with subcutaneous G-CSF or placebo injections from day 1 to 7 after the STEMI. Plasma YKL-40, high-sensitivity C-reactive protein (hs-CRP) and CK-MB concentrations were measured at baseline and during the first month. Infarct size and left ventricular ejection fraction (LVEF) were measured by magnetic resonance imaging at baseline and after 6 months. Results: Baseline plasma YKL-40 was increased (median 92 μg/L) compared to healthy subjects (median 34 μg/L, p <0.001). In the placebo group hs-CRP and YKL-40 correlated at baseline ( p = 0.04) and day 3 ( p = 0.01), but not at day 7 and 30. Moreover, YKL-40 correlated negatively to LVEF recovery ( p = 0.04) but not infarct size. G-CSF injections increased YKL-40 compared to placebo ( p <0.001), but were not associated with infarct size or LVEF recovery. Conclusion: Plasma YKL-40 was significantly increased in STEMI patients at admission and G-CSF treatment caused a further increase in YKL-40. Plasma YKL-40 may be an indirect marker of LVEF recovery, independent of hs-CRP, and higher plasma YKL-40 indicates a lower recovery. [ABSTRACT FROM AUTHOR]