Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
van Royen, N; Schirmer, SH; Atasever, B; Behrens, CY; Ubbink, D; Buschmann, EE; Voskuil, M; Bot, P; Hoefer, I; Schlingemann, RO; Biemond, BJ; Tijssen, JG; Bode, C; Schaper, W; Oskam, J; Legemate, DA; Piek, JJ; Buschmann, I.
START Trial: a pilot study on STimulation of ARTeriogenesis using subcutaneous application of granulocyte-macrophage colony-stimulating factor as a new treatment for peripheral vascular disease.
Circulation. 2005; 112(7): 1040-1046.
Doi: 10.1161/CIRCULATIONAHA.104.529552
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- Co-Autor*innen der Med Uni Graz
- Buschmann Eva Elina
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- Abstract:
- Granulocyte-macrophage colony-stimulating factor (GM-CSF) was recently shown to increase collateral flow index in patients with coronary artery disease. Experimental models showed beneficial effects of GM-CSF on collateral artery growth in the peripheral circulation. Thus, in the present study, we evaluated the effects of GM-CSF in patients with peripheral artery disease. A double-blinded, randomized, placebo-controlled study was performed in 40 patients with moderate or severe intermittent claudication. Patients were treated with placebo or subcutaneously applied GM-CSF (10 microg/kg) for a period of 14 days (total of 7 injections). GM-CSF treatment led to a strong increase in total white blood cell count and C-reactive protein. Monocyte fraction initially increased but thereafter decreased significantly as compared with baseline. Both the placebo group and the treatment group showed a significant increase in walking distance at day 14 (placebo: 127+/-67 versus 184+/-87 meters, P=0.03, GM-CSF: 126+/-66 versus 189+/-141 meters, P=0.04) and at day 90. Change in walking time, the primary end point of the study, was not different between groups. No change in ankle-brachial index was found on GM-CSF treatment at day 14 or at day 90. Laser Doppler flowmetry measurements showed a significant decrease in microcirculatory flow reserve in the control group (P=0.03) and no change in the GM-CSF group. The present study does not support the use of GM-CSF for treatment of patients with moderate or severe intermittent claudication. Issues that need to be addressed are dosing, the selection of patients, and potential differences between GM-CSF effects in the coronary and the peripheral circulation.
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- Angioplasty, Balloon -
- Arterial Occlusive Diseases - drug therapy
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- Arteries - drug effects
- Blood Flow Velocity - drug effects
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- Brachial Artery - pathology
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- Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage
- Granulocyte-Macrophage Colony-Stimulating Factor - therapeutic use
- Humans -
- Injections, Subcutaneous -
- Pilot Projects -
- Placebos -
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- Skin - blood supply
- Walking - physiology
- Find related publications in this database (Keywords)
- angiogenesis
- collateral circulation
- growth substances
- leukocytes
- peripheral vascular disease