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).


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 catheter immediately after the POBA, followed by a postoperative intravenous infusion for 4 h. 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.


CONCLUSIONS
The local delivery of argatroban is safe and effective in preventing restenosis after balloon angioplasty.
Itoh
Tomonori
T
Division of Cardiology, Department of Internal Medicine, National Cardiovascular Center, Suita, Japan.
Nonogi
Hiroshi
H
Miyazaki
Shunichi
S
Itoh
Akira
A
Daikoku
Satoshi
S
Morii
Isao
I
Goto
Yoichi
Y
D000368:Aged; D000800:Angioplasty, Balloon; D001120:Arginine / Q000031:analogs & derivatives; D017023:Coronary Angiography; D003327:Coronary Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010875:Pipecolic Acids / Q000008:administration & dosage* / Q000627:therapeutic use; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D012307:Risk Factors; D013449:Sulfonamides; D013997:Time Factors
D010875:Pipecolic Acids; D010975:Platelet Aggregation Inhibitors; D013449:Sulfonamides; D001120:Arginine; C031942:argatroban