TAXUS III Trial: In-Stent Restenosis Treated With Stent-Based Delivery of Paclitaxel Incorporated in a Slow-Release Polymer Formulation
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.
|Keywords||*Polymers, *Stents/adverse effects, Antineoplastic Agents, Phytogenic/administration & dosage, Coronary Angiography, Coronary Restenosis/diagnosis/prevention & control/*therapy, Delayed-Action Preparations/*administration & dosage, Drug Implants/administration & dosage/adverse effects, Feasibility Studies, Female, Follow-Up Studies, Humans, Male, Middle aged, Paclitaxel/*administration & dosage, Treatment Outcome, drugs, restenosis, stents|
|Persistent URL||dx.doi.org/10.1161/01.CIR.0000048184.96491.8A, hdl.handle.net/1765/10088|
Tanabe, K., Degertekin, M., Grube, E., Russell, M.E., Selbach, G., Staberock, M., … Regar, E.S.. (2003). TAXUS III Trial: In-Stent Restenosis Treated With Stent-Based Delivery of Paclitaxel Incorporated in a Slow-Release Polymer Formulation. Circulation (Baltimore), 107(4), 559–564. doi:10.1161/01.CIR.0000048184.96491.8A