Effect of the polymer-based, paclitaxel-eluting TAXUS Express stent on vascular tissue responses: a volumetric intravascular ultrasound integrated analysis from the TAXUS IV, V, and VI trials.
OBJECTIVE
The TAXUS Express stent has been shown to reduce angiographic restenosis, repeat revascularizations, and neointimal hyperplasia when compared with bare metal stent (BMS) control (TAXUS IV, V, and VI) in individual TAXUS trials. Since intravascular ultrasound (IVUS) methodology and core laboratory were consistent among all three TAXUS trials, an integrated analysis of 956 patients across all IVUS cohorts can be performed providing superior power.


RESULTS
In the TAXUS randomized trials, patients received an Express BMS or paclitaxel-eluting TAXUS Express stent. Volumetric analysis was performed on a selected subgroup at implantation and 9 months. Compared with BMS control, TAXUS increased 9-month lumen volumes (144 +/- 79 vs. 179 +/- 95 mm(3); P < 0.0001) due to reduced neointimal volume (66 +/- 49 vs. 27 +/- 30 mm(3); P < 0.0001). This corresponded to a 61% decrease in net lumen volume obstruction (31 +/- 15 vs. 12 +/- 12 mm(3); P < 0.0001). Lumen loss was similar between groups for the proximal 5 mm outside the stent but was reduced in TAXUS at the distal edge (P = 0.0056). Neointimal hyperplasia was significantly reduced in the double-strut region of overlapping TAXUS vs. BMS control and in high-risk patients with diabetes, long lesions, multiple stents, and multiple overlapping stents. Late-acquired incomplete stent apposition (ISA) was more common with moderate-release TAXUS stents. Importantly, there were no major adverse cardiac events or stent thromboses in any late-acquired ISA patient through 2 years. Univariate and multivariable analyses revealed that longer lesion length and previous myocardial infarction are risk factors for late-acquired ISA.


CONCLUSIONS
Integrated analysis of the TAXUS trials shows that the paclitaxel-eluting TAXUS Express stent effectively inhibits in-stent neointimal proliferation, even in high-risk and overlapping stent patients.
Weissman
Neil J
NJ
Cardiac Ultrasound and Ultrasound Core Laboratory, Cardiovascular Research Institute/Medstar Research Institute, Washington Hospital Center, 100 Irving Street, NW, Suite EB-5123, Washington, DC 20010, USA. neil.j.weissman@medstar.net
Ellis
Stephen G
SG
Grube
Eberhard
E
Dawkins
Keith D
KD
Greenberg
Joel D
JD
Mann
Tift
T
Cannon
Louis A
LA
Cambier
Patrick A
PA
Fernandez
Stephen
S
Mintz
Gary S
GS
Mandinov
Lazar
L
Koglin
Joerg
J
Stone
Gregg W
GW
D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000517:prevention & control*; D004311:Double-Blind Method; D004343:Drug Implants; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009204:Myocardial Revascularization; D017239:Paclitaxel / Q000008:administration & dosage*; D011108:Polymers; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D015607:Stents; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage*; D017539:Tunica Intima / Q000473:pathology; D014463:Ultrasonography
D004343:Drug Implants; D011108:Polymers; D050257:Tubulin Modulators; D017239:Paclitaxel