Paclitaxel coating reduces in-stent intimal hyperplasia in human coronary arteries: a serial volumetric intravascular ultrasound analysis from the Asian Paclitaxel-Eluting Stent Clinical Trial (ASPECT).
BACKGROUND
The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effect of a paclitaxel coating on in-stent intimal hyperplasia (IH).


RESULTS
Patients were randomized to placebo (bare metal stents) or 1 of 2 doses of paclitaxel (low dose: 1.28 microg/mm2; high dose: 3.10 microg/mm2). Complete post-stent implantation and follow-up IVUS were available in 81 patients, including 25 control patients and in 28 receiving a low-dose and 28 receiving a high dose. Volumetric analysis of the stented segment and of both reference segments was performed. Baseline stent measurements and both reference measurements were similar among the groups. With increasing doses, there was a stepwise reduction in IH accumulation within the stented segment (31+/-22 mm3 in control, 18+/-15 mm3 in low dose, and 13+/-14 mm3 in high dose, P<0.001). Post hoc analysis showed less IH accumulation when low- and high-dose patients were compared with control (P=0.009 and P<0.001, respectively), but not when low-dose patients were compared with high-dose patients (P=0.2). Focal late malapposition was seen in 1 high-dose patient. With increasing doses, there was no significant change in the reference segments.


CONCLUSIONS
Paclitaxel-coated stents are effective in reducing in-stent neointimal tissue proliferation in humans. They are not associated with edge restenosis or significant late malapposition.
Hong
Myeong-Ki
MK
Department of Medicine, University of Ulsan College of Medicine, Songpa-gu, Seoul, Korea.
Mintz
Gary S
GS
Lee
Cheol Whan
CW
Song
Jong-Min
JM
Han
Ki-Hoon
KH
Kang
Duk-Hyun
DH
Song
Jae-Kwan
JK
Kim
Jae-Joong
JJ
Weissman
Neil J
NJ
Fearnot
Neal E
NE
Park
Seong-Wook
SW
Park
Seung-Jung
SJ
D002455:Cell Division / Q000187:drug effects; D020099:Coated Materials, Biocompatible / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000601:surgery; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004343:Drug Implants / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia / Q000000981:diagnostic imaging / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000187:drug effects; D018084:Ultrasonography, Interventional
D020099:Coated Materials, Biocompatible; D004343:Drug Implants; D017239:Paclitaxel