European Heart Journal Advance Access originally published online on May 31, 2007
European Heart Journal 2007 28(13):1574-1582; doi:10.1093/eurheartj/ehm174
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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
1 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
2 The Cleveland Clinic Foundation, Cleveland, OH, USA
3 Heart Center Siegburg, Siegburg, Germany
4 Southampton University Hospital, Southampton, UK
5 Florida Hospital, Orlando, FL, USA
6 Wake Heart Research, Raleigh, NC, USA
7 Northern Michigan Hospital, Petoskey, MI, USA
8 Heart and Vascular Institute of Florida, Clearwater, FL, USA
9 Cardiovascular Research Foundation, New York, NY, USA
10 Boston Scientific Corporation, Natick, MA, USA
11 Columbia University Medical Center, New York, NY, USA
Received 13 July 2006; revised 9 April 2007; accepted 19 April 2007; online publish-ahead-of-print 31 May 2007.
* Corresponding author. Tel: +1 202 877 0223; fax: +1 202 877 0206. E-mail address: neil.j.weissman{at}medstar.net or lperrotta{at}adelphia.net
Aims: 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.
Methods and 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 mm3; P < 0.0001) due to reduced neointimal volume (66 ± 49 vs. 27 ± 30 mm3; P < 0.0001). This corresponded to a 61% decrease in net lumen volume obstruction (31 ± 15 vs. 12 ± 12 mm3; 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.
Conclusion: 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.
Key Words: Stents • Restenosis • Diabetes mellitus • Revascularization • Ultrasonics
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