Despite recent advances in interventional cardiology including the success of drug-eluting
stents in de-novo coronary lesions, the treatment of in-stent restenosis remains a
challenging clinical issue. Given the efficacy of the systemic sirolimus administration to
prevent neointimal hyperplasia in animal models and to halt and even reverse the progression
of allograft vasculopathy, the aim of the present double-blind, placebo-controlled study was
to evaluate the efficacy of a 10-day oral sirolimus treatment with two different loading
regimens for the prevention of recurrent restenosis in patients with in-stent restenosis.