Key result
Local delivery of argatroban significantly reduced the angiographic restenosis rate to 27% compared to 56% with conventional therapy after plain old balloon angioplasty.
Why the study?
Does local delivery of argatroban prevent restenosis after plain old balloon angioplasty in patients with chronic coronary artery disease?
RCT (n=70)
Open-label
Sealed envelopes
No
Does local delivery of argatroban prevent restenosis after plain old balloon angioplasty in patients with chronic coronary artery disease?
Absolute Event Rate: 27% vs 56%
p-value: p=0.02
Local delivery of argatroban combined with intravenous infusion significantly reduces angiographic and clinical restenosis after plain old balloon angioplasty.
Supports local argatroban after POBA in chronic CAD; confirms targeted antithrombin delivery via RCT.
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 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. CONCLUSION: The local delivery of argatroban is safe and effective in preventing restenosis after balloon angioplasty.
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Itoh et al. (2004) conducted an RCT in Chronic coronary artery disease (n=70). Argatroban vs. Conventional POBA with heparin was evaluated on Angiographic restenosis (>50% diameter stenosis at follow-up) (p=0.02). Local delivery of argatroban significantly reduced the angiographic restenosis rate to 27% compared to 56% with conventional therapy after plain old balloon angioplasty.
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