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: ObjectivesThis study was designed to determine whether antisense oligodeoxynucleotides (ODN) directed against the nuclear proto-oncogene c-myc could inhibit restenosis when given by local delivery immediately after coronary stent implantation.: BackgroundFailure of conventional pharmacologic therapies to reduce the incidence of coronary restenosis after percutaneous revascularization techniques has prompted interest in the use of agents that target intracellular central regulatory mechanisms.: MethodsEighty-five patients were randomly assigned to receive either 10 mg of phosphorothioate-modified 15-mer antisense ODN or saline vehicle by intracoronary local delivery after coronary stent implantation. The primary end point was percent neointimal volume obstruction measured by computerized analysis of electrocardiogram-gated intravascular ultrasound (IVUS) at six-month follow-up. Secondary end points included clinical outcome and quantitative coronary angiography analysis.: ResultsAnalysis of follow-up IVUS data was performed on 77 patients. In-stent volume obstruction was similar between groups (44 ± 16% and 46 ± 14%, placebo vs. ODN; p = 0.57; 95% confidence interval: −1.13 to 0.85). Minimum luminal diameter increased from 0.84 ± 0.36 and 0.90 ± 0.45 (p = 0.55) to 2.70 ± 0.37 and 2.80 ± 0.37 (p = 0.28) after stent implantation, which decreased to 1.50 ± 0.61 and 1.50 ± 0.53 (p = 0.98) by six months, yielding similar loss indexes (placebo vs. ODN, respectively). There were no differences in angiographic restenosis rates (38.5 and 34.2%; p = 0.81; placebo vs. ODN) or clinical outcome.: ConclusionsTreatment with 10 mg of phosphorothioate-modified ODN directed against c-myc does not reduce neointimal volume obstruction or the angiographic restenosis rate in this patient population. [Copyright &y& Elsevier]