Chronic arterial responses to polymer-controlled paclitaxel-eluting stents: comparison with bare metal stents by serial intravascular ultrasound analyses: data from the randomized TAXUS-II trial.
BACKGROUND
Polymer-controlled paclitaxel-eluting stents have shown a pronounced reduction in neointimal hyperplasia compared with bare metal stents (BMS). The aim of this substudy was to evaluate local arterial responses through the use of serial quantitative intravascular ultrasound (IVUS) analyses in the TAXUS II trial.


RESULTS
TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This IVUS substudy included patients treated with one study stent who underwent serial IVUS examination after the procedure and at 6-month follow-up (BMS, 152 patients; SR, 81; MR, 81). The analyzed stented segment (15 mm) was divided into 5 subsegments in which mean vessel area (VA), stent area (SA), lumen area (LA), intrastent neointimal hyperplasia area (NIHA), and peristent area (VA-SA) were measured. NIHA was significantly reduced in SR (0.7+/-0.9 mm2, P<0.001) and MR (0.6+/-0.8 mm2, P<0.001) compared with BMS (1.9+/-1.5 mm2), with no differences between the two paclitaxel-eluting release formulations. Longitudinal distribution of neointimal hyperplasia throughout the paclitaxel-eluting stent was uniform. Neointimal growth was independent of peristent area at postprocedure examination in all groups. There were progressive increases in peristent area from BMS to SR to MR (0.5+/-1.7, 1.0+/-1.8, and 1.4+/-2.0 mm2, respectively; P<0.001). The increase in peristent area was directly correlated with increases in VA.


CONCLUSIONS
Both SR and MR paclitaxel-eluting stents prevent neointimal formation to the same degree compared with BMS. However, the difference in peristent remodeling suggests a release-dependent effect between SR and MR.
Tanabe
Kengo
K
Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
Serruys
Patrick W
PW
Degertekin
Muzaffer
M
Guagliumi
Giulio
G
Grube
Eberhard
E
Chan
Charles
C
Munzel
Thomas
T
Belardi
Jorge
J
Ruzyllo
Witold
W
Bilodeau
Luc
L
Kelbaek
Henning
H
Ormiston
John
J
Dawkins
Keith
K
Roy
Louis
L
Strauss
Bradley H
BH
Disco
Clemens
C
Koglin
Jörg
J
Russell
Mary E
ME
Colombo
Antonio
A
D017130:Angioplasty; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000473:pathology / Q000517:prevention & control*; D001158:Arteries / Q000000981:diagnostic imaging*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008670:Metals; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use; D011108:Polymers / Q000627:therapeutic use; D015607:Stents; D017539:Tunica Intima / Q000473:pathology; D014463:Ultrasonography
D008670:Metals; D011108:Polymers; D017239:Paclitaxel