This study evaluated the safety and efficacy of a dexamethasone-eluting stent with a special high dexamethasone-loading dose for treatment of de novo coronary lesions in 30 patients. Eight patients had in-stent restenosis (restenosis rate 31%) at 6-month follow-up, and the in-stent late lumen loss was 0.96 +/- 0.63 mm due to an average intimal hyperplasia area obstruction of 32 +/- 21%, indicating that high-dose dexamethasone-loaded stents do not significantly reduce neointimal proliferation.