February 3, 2003Circulation320 citationsOpen Access
View Full PaperTAXUS III Trial
Key Result
Treatment of in-stent restenosis with paclitaxel-eluting stents resulted in a 29% major adverse cardiac event rate and a mean late loss of 0.54 mm, with no subacute stent thrombosis at 12 months.
Study Design
Type
Observational (n=28)
Multicenter
Yes
Structured PICO
Is paclitaxel-eluting stent implantation safe and feasible for the treatment of in-stent restenosis?
P
Population
28 patients with in-stent restenosis (ISR) meeting criteria of lesion length <=30 mm, 50% to 99% diameter stenosis, and vessel diameter 3.0 to 3.5 mm.
I
Intervention
TAXUS NIRx paclitaxel-eluting stents (one or more)
O
Outcome
Feasibility and safetysafety
Paclitaxel-eluting stents show potential safety and efficacy for treating in-stent restenosis, with IVUS guidance recommended to optimize deployment and reduce reintervention.
Abstract
BACKGROUND: The first clinical study of paclitaxel-eluting stent for de novo lesions showed promising results. We performed the TAXUS III trial to evaluate the feasibility and safety of paclitaxel-eluting stent for the treatment of in-stent restenosis (ISR). METHODS AND RESULTS: The TAXUS III trial was a single-arm, 2-center study that enrolled 28 patients with ISR meeting the criteria of lesion length < or =30 mm, 50% to 99% diameter stenosis, and vessel diameter 3.0 to 3.5 mm. They were treated with one or more TAXUS NIRx paclitaxel-eluting stents. Twenty-five patients completed the angiographic follow-up at 6 months, and 17 of these underwent intravascular ultrasound (IVUS) examination. No subacute stent thrombosis occurred up to 12 months, but there was one late chronic total occlusion, and additional 3 patients showed angiographic restenosis. The mean late loss was 0.54 mm, with neointimal hyperplasia volume of 20.3 mm3. The major adverse cardiac event rate was 29% (8 patients; 1 non-Q-wave myocardial infarction, 1 coronary artery bypass grafting, and 6 target lesion revascularization TLR). Of the patients with TLR, 1 had restenosis in a bare stent implanted for edge dissection and 2 had restenosis in a gap between 2 paclitaxel-eluting stents. Two patients without angiographic restenosis underwent TLR as a result of the IVUS assessment at follow-up (1 incomplete apposition and 1 insufficient expansion of the stent). CONCLUSIONS: Paclitaxel-eluting stent implantation is considered safe and potentially efficacious in the treatment of ISR. IVUS guidance to ensure good stent deployment with complete coverage of target lesion may reduce reintervention.