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News

Next-generation stent shows improved clinical outcomes in long lesions and small vessels

Boston Scientific : 22 October, 2007  (New Product)
Boston Scientific has revealed nine month data from the pivotal Taxus Atlas Small Vessel and Long Lesion studies, which evaluate the Taxus Liberte Paclitaxel-Eluting Stent System in complex lesions.
The Taxus Liberte 2.25 mm Stent significantly reduced restenosis and maintained or improved safety outcomes compared to the first-generation Taxus Expres Stent, which has been used in more than four million implants since 2003 and has been the benchmark against which many newer stents have been compared.

The Taxus Liberte Long (38mm) Stent showed further significant reduction in the incidence of Non-Q-Wave Myocardial Infarction (MI, or heart attack) occurring at the time of the procedure compared to the earlier generation Taxus stent. The data also demonstrated enhanced deliverability for both the Taxus Liberte 2.25mm Stent and for the Taxus Liberte Long Stent.

The results were presented by Mark A Turco, MD, director of the Center for
Cardiac and Vascular Research, Washington Adventist Hospital, and co- principal investigator of the trial, at the Cardiovascular Research Foundation's (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC, USA.

'The Taxus Atlas studies show the Taxus Liberte Stent to be highly deliverable in complex lesions, while significantly reducing restenosis in small vessels,' said Dr Turco. 'The positive data from the Taxus Atlas studies suggest that improvements in Stent design and a reduction in strut thickness may contribute to improved clinical outcomes for Taxus Liberte in these difficult and challenging lesions.'

'Results from the Taxus Atlas studies demonstrate the successful transfer of
Boston Scientific's leading paclitaxel technology to our next-generation
Taxus Liberte Stent,' said Paul LaViolette, chief operating officer of Boston
Scientific.

'Improved clinical outcomes and positive data on deliverability in complex lesions are a powerful demonstration of the continued leadership of Boston Scientific and our Taxus Stent platform. Taxus Liberte is the preferred drug-eluting Stent in virtually every country where it is sold, and we look forward to bringing this technology to the USA in 2008.'

The Taxus Atlas Small Vessel and Long Lesion studies are global, multi-
center, historically controlled trials investigating de novo lesions in 411 patients at 24 sites.

The Small Vessel study was designed to evaluate the safety and efficacy of the Taxus Liberte 2.25mm Stent for superiority compared to a case-matched historical bare-metal Stent (BMS) control (Express Stent), and non-inferiority against a case-matched historical control of Taxus Express Stent patients.

The Long Lesion study was designed to demonstrate that the Taxus Liberte Long (38mm) Stent is non-inferior in safety and efficacy compared to a case-matched historical control of Taxus Express Stent patients.

The Small Vessel study met its primary superiority endpoint compared to the
BMS group (45.6 percent vs. 32.1 percent diameter stenosis, p <0.0001) and non- inferiority compared to the Taxus Express group (38.4 percent vs. 32.1 percent diameter stenosis, p=0.0351).

The Taxus Liberte 2.25 mm Stent showed significant statistical reduction in target lesion revascularization (TLR) at nine months with a rate of 5.8 percent as compared to 13.7 percent in the Taxus Express Stent (p=0.024), resulting in a 58 percent relative reduction. Overall target vessel revascularization (TVR) was 10.1 percent for the Taxus Liberte Stent compared to 17.8 percent for the Taxus Express Stent (p=0.07).

Major adverse cardiac events (MACE) for the Taxus Liberte 2.25mm Stent was 12.8 percent compared to 20.5 percent for the Taxus Express Stent (p=0.10), a relative reduction of 38 percent. All cause death was 1.2 percent for the Taxus Liberte 2.25 mm Stent group and 2.7 percent for the Taxus Express group (p=0.30).

ARC-defined total Stent thrombosis to nine months was 0.4 percent for the Taxus Liberte 2.25mm Stent compared to 1.3 percent for the BMS control (p=0.56) and 1.4 percent for the Taxus Express Stent control group (p=0.39).

The Taxus Liberte Long (38mm) Stent met its primary endpoint of non- inferiority to the Taxus Express control Stent in percent diameter stenosis (32.6 percent vs. 31.7 percent, p=0.71).

Overall TVR was 8.7 percent for the Taxus Liberte Long Stent compared to 8.5 percent for the Taxus Express Stent (p=0.93). Enhanced deliverability was demonstrated through clinical procedural success, which favoured the Taxus Liberte Long Stent over the Taxus Express Stent (100.0 percent vs. 96.3 percent, p=0.0431).

Myocardial infarction (MI) was significantly reduced in Taxus Liberte Long Stent patients compared to Taxus Express patients (1.3 percent vs. 6.3 percent, p=0.026). The reduction in MI was primarily driven by a decrease in in-hospital Non-Q-Wave MI in the Taxus Liberte Stent group as compared to the Taxus Express Stent group (0.0 percent vs. 4.1 percent, p=0.013).

The MI reduction in Taxus Liberte Long patients was also reported in a cohort of single Stent patients (1.6 percent vs. 9.1 percent, p=0.0213).

All cause death was reported as 2.8 percent for the Taxus Express Stent and 0.7 percent for the Taxus Liberte Long Stent (p=0.21).

The Taxus Liberte Long Stent showed no Stent thrombosis at 284 days using either the Protocol Definition or the ARC Definition while the Taxus Express control Stent reported 0.7 percent (p=0.49) using the Protocol Definition and 1.4 percent (p=0.24) using the ARC Definition.

The company received the CE Mark for the Taxus Liberte Stent in Europe and other international markets in September 2005, and it is currently the market-leading drug-eluting Stent outside the United States excluding Japan (the Taxus Liberte Stent is not available for sale in Japan).

The company received CE Mark for the Taxus Liberte Long Stent in May 2007. The Taxus Liberte Stent and the Taxus Express 2.25mm Stent are currently pending approval by the US Food and Drug Administration and are limited by federal law to investigational use and not available for sale in the USA. The company plans to launch the Taxus Liberte Stent in the USA in 2008.
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