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).


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.
Tanabe
Kengo
K
Division of Cardiology, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
Serruys
Patrick W
PW
Grube
Eberhard
E
Smits
Pieter C
PC
Selbach
Guido
G
van der Giessen
Willem J
WJ
Staberock
Manfred
M
de Feyter
Pim
P
Müller
Ralf
R
Regar
Evelyn
E
Degertekin
Muzaffer
M
Ligthart
Jurgen M R
JM
Disco
Clemens
C
Backx
Bianca
B
Russell
Mary E
ME
D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000517:prevention & control / Q000628:therapy*; D003692:Delayed-Action Preparations / Q000008:administration & dosage*; D004343:Drug Implants / Q000008:administration & dosage / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011108:Polymers; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D003692:Delayed-Action Preparations; D004343:Drug Implants; D011108:Polymers; D017239:Paclitaxel