Prospective randomized trial of corticosteroids for the prevention of restenosis after intracoronary stent implantation

Background: Inflammatory responses have been implicated as one of the major contributors to neointimal hyperplasia after coronary stenting. The aim of this study was to evaluate the effect of pretreatment with single-dose intravenous methylprednisolone on preventing in-stent restenosis. Methods: One hundred and forty consecutive patients for elective coronary stenting (focal, de nova lesion and reference diameter ≥3 mm) were randomly assigned to either a methylprednisolone or a placebo group. Either 1 g methylprednisolone or placebo was intravenously infused 6 to 12 hours before stenting with one of two types of stents. Follow-up angiography was performed at 6 months and clinical evaluation made at regular intervals. Results: Baseline characteristics were similar between both groups. Stenting was successful in all patients, and in-hospital events did not occur in any patients. Follow-up angiography was performed in 127 patients (follow-up rate of 91.4%). The minimal lumen diameter increased from 0.86 ± 0.50 mm before intervention to 3.34 ± 0.42 mm after intervention (P = .02). At follow-up, minimal lumen diameter decreased to 2.14 ± 0.78 mm (P < .01). Angiographic restenosis rate was 17.5% in the steroid group and 18.8% in the placebo group (P = .85), with no differences between the 2 types of stent. Clinical follow- up was available in all patients (10.3 ± 2.5 months) and clinical events during the follow-up period were similar in both groups. Conclusions: Single- dose pretreatment with intravenous methylprednisolone before coronary stenting had no effect on the change in minimal lumen diameter at a mean follow-up time.