Taxus stent

Morice M-C, Serruys PVY, Colombo A, et al. Eight-month outcome of the REALITY Study a prospective, randomized, multi-center head-to-head comparison of the sirolimus-eluting stent (Cypher) and the paclitaxel-eluting stent (Taxus). Presented at the 2005 Annual Scientific Session ofthe American College of Cardiology, Orlando, FL, March 6-9, 2005. 

Administration (FDA) approval of SIBS, used as the polymeric coating on the Taxus coronary stent, opened new avenues for polyisobutylene-based TPEs in biomedical engineering. 

US FDA. Taxus Express 2 PacUtaxel-Eluting Coronary Stent System (Monorail and Over the Wire), P030025, 2004. 

Ranade, S.V. et al. Physical characterization of controlled release of pacUtaxel from the TAXUS Express 2 drug-eluting stent, J. Biomed. Mater. Res., 71 A, 625, 2004. 

The pivotal US trial for the Paclitaxel stent was the TAXUS IV trial, which enrolled 1,314 patients with single de novo coronary lesions (Length 10-28 mm and diameter 2.5-3.75 mm) [67] (Fig. 5.7). Target vessel revascularization based on ischemic symptoms was reduced from 12 to 4.7% p < 0.001). The rate of restenosis by angiography was considerable lower (7.9% versus 26.6% p < 0.001), with no difference in the rate of cardiac death, myocardial infarction, or stent thrombosis. 

Fig. 5.7 TAXUS IV 9 month sub-group analysis of the Paditaxel eluting stent versus comparative bare metal stent ( 2004 Massachusetts Medical Society)...

Another sirolimus analogue, Everolimus, on cobalt chromium stent platform (XIENCE V stent, Abbott Laboratories, Abbott Park, Illinois), was compared to the TAXUS stent in the SPIRIT III trial and found to have better MACE rates. The XIENCE V is approved in Europe and is awaiting FDA approval. 

Abbreviations DES, drug-eluting stents MACCE, major adverse cardiac and cerebrovascular events SIRIUS. E- SIRIUS. TAXUS II. TAXUS IV, TAXUS V. ORAR II TVR target vessel revascularization. 

Grube E, Silber S, Hauptmann KE, et al. TAXUS I. Six- and twelve month results from a randomized, double-blind trial on a slow-release pacIitaxeI-eIuting stent for de novo coronary lesions, Circulation 2003 107 38-42,... 

Tanabe (140) (TAXUS 111) 2003 NIRx Translute Human coronary art (in-stent restenosis) Paclitaxel 1 xg/mm2 Bare Yes... 

Bullesfeld L, Gerckens U, Muller R, Grube E. Long-term evaluation of paditaxel-coated stents for treatment of native coronary lesions. First results of both the clinical and angiographic 18 month follow-up of TAXUS I. Z Kardiol 2003 92(l0) 825-832. 

Tanabe K, Serruys FW, Grube E, et al. TAXUS III Trial instent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation 2003 107(4)559-564. 

Stone GW, Ellis SG, Cox DA, et al. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent the TAXUS-IV trial. Circulation 2004 ... 

A multidisciplinary approach has been adopted to define the best DES design for use as a CDD system, This chapter discusses the principles of CDD and considers its application to the development of polymer-based DES using the TAXUS paclitaxel-eluting stent (Boston Scientific Corporation, Natick, Massachusetts, U.S.A.) as an example of this technology. 

Scanning electron micrographs of the TAXUS stent poststerilization and expansion. (A) Low magnification, (B) high magnification. Source From Ref. 55. 

Clinical experience with Taxus paclitaxel-eluting stent... 

Ranade SV, Miller KM, Richard RE, Chan AK, Allen MJ, Helmus MN. Physical characterization of controlled release of pacli-taxel from the TAXUS Express2 drug-eluting stent. J Biomed Mater Res A 2004 71 (4) 625-634. 

Kamath KR, Barry JJ, Miller KM. The Taxus drug-eluting stent a new paradigm in controlled drug delivery. Adv Drug Deliv Rev 2006 58(3/412-436. 

Dawkins KD, Stone GW, Colombo A, et al. Integrated analysis of medically treated diabetic patients in the TAXUS program benefits across stent platforms, paclitaxel release formulations, and diabetic treatments. Eurointervention 2006 2 61-68. 

DES in the United States at this time. They are the Cypher sirolimus-eluting stent manufactured by Cordis, a division of Johnson Johnson and the Taxus paclitaxel-eluting stent manufactured by Boston Scientific. 

The Taxus stent by Boston Scientific uses a tri-block copolymer [poly(styrene-b-isobutylene-b-styrene)] for sustained delivery of paclitaxel. This new polymer is specifically designed for this use and has a trade name of Translute , Paclitaxel can be released at a fast or a slow rate by varying the drug loading in the polymer matrix as shown in Figure 4. 

The first study of the TAXUS paclitaxel-eluting stent in humans, TAXUS I, reported major adverse cardiac events at one-year follow-up at 3.2% for the TAXUS DES group versus 10.0% for the BMS control group (p = NS) (68). TAXUS I, now has data through four years and these benefits were maintained for the TAXUS group (Fig. 12). 

See color plate) Sustained freedom from target lesion revascularization in TAXUS clinical trials. Abbreviations BMS, bare-metal stent MR, moderate-release PES, paclitaxel-eluting stent SR, slow-release. Source From Ref. 73. 

Lasala JM, Stone GW, Dawkins KD, et al. An overview of the TAXUS EXPRESS paclitaxel-eluting stent clinical trial program. J Interv Cardiol 2006 19 422-43 I. 

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