Background Cytokines play an important role in modulating inflammatory and proliferative responses, including atherosclerosis. Transforming growth factor-beta (TGF-beta) and macrophage-colony stimulating factor (M-CSF) are one of the major antiinflammatory and proinflammatory cytokines, respectively. We have previously demonstrated that plasma concentrations of TGF-alpha are decreased while those of M-CSF are increased in patients with coronary artery disease (CAD). In this study, we examined whether those alterations in plasma levels of cytokines have a prognostic significance in patients with CAD. Methods and results Sixty-eight consecutive patients with proven CAD were studied. The plasma concentrations of TGF-beta and those of M-CSF were measured by enzyme-linked immunosorbent assay (ELISA). They were divided into groups: high (greater than or equal to6 ng/ml, n = 19) and low (< 6 ng/ml, n = 49) TGF-β groups and high (> 500 ng/ml, n = 52) and low (less than or equal to 500 ng/ml, n = 16) M-CSF groups. The long-term prognosis of these patients was prospectively followed up for a mean period of 979 +/- 27 days. The prognosis was analyzed by Kaplan-Meier analysis in terms of total survival, survival without myocardial infarction, survival without cardiovascular events and survival without coronary interventions. The analysis showed that the low TGF-beta group had a significantly poor prognosis in terms of survival without cardiovascular events and survival without coronary interventions as compared with the high TGF-beta group (both P < 0.05), while other prognoses were comparable between the two groups. By contrast, no significant prognostic influence was noted regarding M-CSF. Conclusions These results suggest that plasma concentrations of TGF-β may have a prognostic significance in patients with CAD.