Local delivery of argatroban for the prevention of restenosis after coronary balloon angioplasty - A prospective randomized pilot study

Background Effective pharmacological prevention of restenosis using the systemic administration of various drugs that were effective for the prevention of restenosis in experimental studies has not been reported. The purpose of this study was to evaluate whether the local delivery of a potent thrombin inhibitor, argatroban, using a local drug delivery device would prevent restenosis after plain old balloon angioplasty (POBA). Methods and Results Seventy patients with chronic coronary artery disease requiring POBA were randomly assigned to wither the control group (n = 35) or the argatroban group (n = 35). In the argatroban group, argatroban was administered intravenously for 30 min before the POBA and intracoronarily into the dilated site using a Dispatch(TM) catheter immediately after the POBA, followed by a postoperative intravenous infusion for 4h. The angiographical lesion restenosis and clinical restenosis rates at follow-up were significantly lower in the argatroban group (27% and 14%) than in the control group (56% and 37%; p = 0.02 and p = 0.03, respectively). There was no major complication during the procedure. Conclusion The local delivery of argatroban is safe and effective in preventing restenosis after balloon angioplasty.