Published online before print March 12, 2006, doi: 10.1161/CIRCULATIONAHA.105.610469
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(Circulation. 2006;113:1983-1992.)
© 2006 American Heart Association, Inc.
Vascular Medicine |
Stem Cell Mobilization Induced by Subcutaneous Granulocyte-Colony Stimulating Factor to Improve Cardiac Regeneration After Acute ST-Elevation Myocardial Infarction
Result of the Double-Blind, Randomized, Placebo-Controlled Stem Cells in Myocardial Infarction (STEMMI) Trial
From the Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet, Copenhagen (R.S.R., E.J., Y.W., J.J.T., L.S., L.K., P.G., J.K.); Department of Radiology, University Hospital Rigshospitalet, Copenhagen (R.S.R.); Danish Research Centre for Magnetic Resonance, University Hospital Hvidovre, Hvidovre (J.C.N.); and Department of Haematology, Aalborg University Hospital, Aalborg (H.E.J.), Denmark.
Correspondence to Jens Kastrup, MD, DMSc, Medical Department B, Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital Rigshospitalet, DK-2100 Copenhagen Ø, Denmark. E-mail:jkastrup{at}rh.hosp.dk
Received January 13, 2006; revision received February 23, 2006; accepted February 27, 2006.
Background— Phase 1 clinical trials of granulocyte-colony stimulating factor (G-CSF) treatment after myocardial infarction have indicated that G-CSF treatment is safe and may improve left ventricular function. This randomized, double-blind, placebo-controlled trial aimed to assess the efficacy of subcutaneous G-CSF injections on left ventricular function in patients with ST-elevation myocardial infarction.
Methods and Results— Seventy-eight patients (62 men; average age, 56 years) with ST-elevation myocardial infarction were included after successful primary percutaneous coronary stent intervention <12 hours after symptom onset. Patients were randomized to double-blind treatment with G-CSF (10 µg/kg of body weight) or placebo for 6 days. The primary end point was change in systolic wall thickening from baseline to 6 months determined by cardiac magnetic resonance imaging (MRI). An independent core laboratory analyzed all MRI examinations. Systolic wall thickening improved 17% in the infarct area in the G-CSF group and 17% in the placebo group (P=1.0). Comparable results were found in infarct border and noninfarcted myocardium. Left ventricular ejection fraction improved similarly in the 2 groups measured by both MRI (8.5 versus 8.0; P=0.9) and echocardiography (5.7 versus 3.7; P=0.7). The risk of severe clinical adverse events was not increased by G-CSF. In addition, in-stent late lumen loss and target vessel revascularization rate in the follow-up period were similar in the 2 groups.
Conclusions— Bone marrow stem cell mobilization with subcutaneous G-CSF is safe but did not lead to further improvement in ventricular function after acute myocardial infarction compared with the recovery observed in the placebo group.
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