Key result
GM-CSF increases coronary collateral flow index vs placebo but triggers ACS in ~29% of patients.
Why the study?
Does subcutaneous GM-CSF improve collateral flow index in men with chronic stable CAD?
RCT (n=14)
Double-blind
randomized
Does subcutaneous GM-CSF improve collateral flow index in men with chronic stable CAD?
Absolute Event Rate: 0.042% vs -0.001%
p-value: p=0.035
A short-term subcutaneous GM-CSF protocol effectively promotes coronary collateral artery growth in stable CAD but raises significant safety concerns regarding the induction of acute coronary syndromes.
OBJECTIVES: This study was designed to investigate the safety and efficacy of a short-term subcutaneous-only granulocyte-macrophage colony-stimulating factor (GM-CSF) protocol for coronary collateral growth promotion. BACKGROUND: The safety and efficacy of an exclusively systemic application of GM-CSF in patients with coronary artery disease (CAD) and collateral artery promotion has not been studied so far. METHODS: In 14 men (age 61 +/- 11 years) with chronic stable CAD, the effect of GM-CSF (molgramostim) on quantitatively assessed collateral flow was tested in a randomized, double-blind, placebo-controlled fashion. The study protocol consisted of an invasive collateral flow index (CFI) measurement in a stenotic as well as a normal coronary artery before and after a two-week period with subcutaneous GM-CSF (10 microg/kg; n = 7) or placebo (n = 7). Collateral flow index was determined by simultaneous measurement of mean aortic, distal coronary occlusive, and central venous pressure. RESULTS: Collateral flow index in all vessels changed from 0.116 +/- 0.05 to 0.159 +/- 0.07 in the GM-CSF group (p = 0.028) and from 0.166 +/- 0.06 to 0.166 +/- 0.04 in the placebo group (p = NS). The treatment-induced difference in CFI was +0.042 +/- 0.05 in the GM-CSF group and -0.001 +/- 0.04 in the placebo group (p = 0.035). Among 11 determined cytokines, chemokines, and their monocytic receptor concentrations, the treatment-induced change in CFI was predicted by the respective change in tumor necrosis factor-alpha concentration. Two of seven patients in the GM-CSF group and none in the placebo group suffered an acute coronary syndrome during the treatment period. CONCLUSIONS: A subcutaneous-only, short-term protocol of GM-CSF is effective in promoting coronary collateral artery growth among patients with CAD. However, the drug's safety regarding the occurrence of acute coronary syndrome is questionable.
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Zbinden et al. (2005) conducted an RCT in chronic stable coronary artery disease (CAD) (n=14). Granulocyte-macrophage colony-stimulating factor (GM-CSF / molgramostim) vs. Placebo was evaluated on Treatment-induced difference in collateral flow index (CFI) (p=0.035). A two-week protocol of subcutaneous GM-CSF significantly increased coronary collateral flow index compared to placebo (+0.042 vs -0.001; p=0.035), though 2 of 7 treated patients suffered an ACS.
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