Comparison of neointimal formation in polymer-free paclitaxel stents versus stainless stents (from the ASPECT and ELUTES randomized clinical trials).
The investigators examined 326 pairs of angiograms from 2 randomized dose-finding (0.2 to 3.1 microg paclitaxel/mm(2) of stent surface area) clinical trials of polymer-free paclitaxel-eluting stents in de novo lesions (the ASian Paclitaxel-Eluting stent Clinical Trial [ASPECT] and the European evaLUation of Taxol Eluting Stent [ELUTES]). A dose-dependent effect was observed: the largest dose of paclitaxel in the 2 trials resulted in a significantly larger proportion of lesions at follow-up with <10% diameter stenosis (54% vs 16%, p = 0.00012 in ASPECT; 53% vs 21%, p = 0.013 in ELUTES) and with minimal luminal diameter located outside the stent compared with control stents (62% vs 20% in ASPECT, 48% vs 18% in ELUTES; p <0.05). Also, significantly shorter lesion lengths at 6-month follow-up were observed for the doses of 0.7 to 3.1 microg/mm(2) (p <0.03) relative to their respective lengths before the procedure compared with control stents.
Kałuza
Grzegorz L
GL
The Methodist DeBakey Heart Center and Baylor College of Medicine, Houston, Texas, USA. gkaluza@bcm.tmc.edu
Gershlick
Anthony H
AH
Park
Seung-Jung
SJ
De Scheerder
Ivan
I
Chevalier
Bernard
B
Camenzind
Edoardo
E
Goy
Jean-Jacques
JJ
Missault
Luc
L
Reifart
Nicolaus
N
Vrints
Christiaan
C
Urban
Philip
P
Shim
Won Heum
WH
Ho
David Sai Wah
DS
Fearnot
Neal E
NE
Voorhees
William D
WD
Raizner
Albert E
AE
D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D006965:Hyperplasia / Q000517:prevention & control; D017239:Paclitaxel / Q000008:administration & dosage*; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D013193:Stainless Steel; D015607:Stents; D017539:Tunica Intima / Q000473:pathology*
D020533:Angiogenesis Inhibitors; D013193:Stainless Steel; D017239:Paclitaxel