Stem cell mobilization by granulocyte-colony Stimulating Factor in patients with acute myocardial infarction: five-year results of the REVIVAL-2 trial

Abstract

Background: The REVIVAL-2 study showed that stem cell mobilization by G-CSF does not influence infarct size, left ventricular function and coronary restenosis in patients with AMI that underwent successful percutaneous coronary intervention (PCI). The objective of the present analysis was to assess the impact of G-CSF treatment on 5-year clinical outcomes from the REVIVAL-2 trial. Methods and results: In the randomized, double-blind, placebo-controlled REVIVAL-2 study, 114 patients with the diagnosis of acute myocardial infarction were enrolled 5 days after successful reperfusion by percutaneous coronary intervention. Patients were assigned to receive 10 μg/kg G-CSF (56 patients) or placebo (58 patients) for 5 days. The primary outcome for this analysis was the composite of death, myocardial infarction or stroke 5 years after randomization. The endpoint occurred in 7.1% of patients in the G-CSF group versus 15.5% assigned to placebo (relative risk [RR], 0.5; 95% confidence interval [CI], 0.1-1.4; p=0.17). The combined incidence of death or myocardial infarction occurred in 5.4% of the patients assigned to G-CSF and 13.8% of the patients assigned to placebo (RR, 0.4; 95% CI, 0.1-1.4; p=0.14). The major driver was mortality which was reduced from 10.3% in the placebo group to 3.6% in the G-CSF group (p=0.16). Conclusion: These long term follow-up data show that G-CSF may reduce adverse events especially mortality in patients with acute myocardial infarction. ClinicalTrials.gov Identifier: [NCT00126100][1] [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00126100&atom=%2Fehj%2F34%2Fsuppl_1%2FP435.atom