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News

Promus and Taxus stents report further safety performance results

Boston Scientific : 22 October, 2007  (New Product)
Boston Scientific has welcomed results from the SPIRIT III Clinical Trial, which continue to support the proven safety and efficacy of the Taxus Express2 Paclitaxel-Eluting Coronary Stent System and add to the growing body of strong clinical evidence for the Xience V (Promus) Everolimus Eluting Coronary Stent System.
An analysis of the data was presented by Gregg W Stone, MD, of Columbia University Medical Center and the Cardiovascular Research Foundation in New York, and the Principal Investigator of the SPIRIT III Trial, during a late- breaking trial session at the Cardiovascular Research Foundation's (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC, USA.

One year results from the SPIRIT III trial included an updated analysis of
1,002 patients with coronary artery disease treated with either the Xience V
(Promus) Stent or the Taxus Express Stent.

Ischemia-driven target lesion revascularization (TLR) for 669 patients treated with the Xience V (Promus) Stent changed from 2.6 percent to 3.3 percent between nine months and one year, while for the 333 patients treated with the Taxus Stent, TLR changed from 5.0 percent to 5.6 percent during the same time period, still failing to reach statistical significance (p=0.09). Target vessel revascularization (TVR) at one year was also similar, with 6.1 percent for Promus and 7.5 percent for Taxus (p=0.41).

The overall MACE (Major Adverse Cardiac Events) rate (defined as cardiac death, myocardial infarction (heart attack, or MI) or ischemia-driven TLR) through one year was 5.8 percent for the Xience V (Promus) Stent and 9.9 percent for the Taxus Stent (p=0.01), reflecting an increased number of small (non-Q wave) MIs at the time of the procedure (2.5 percent vs. 3.8 percent).

Subset analysis showed especially strong performance of the Taxus Stent in diabetic patients with MACE rates remaining low at 4.7 percent, while MACE rates increased in the Xience V (Promus) Stent to 8.8 percent.

In long lesions (lesion length>13.2mm), MACE was 7.7 percent for the Xience V (Promus) Stent and 8.0 percent for the Taxus Stent; in small vessels (RVD< / =2.775 mm), 6.1 percent for the Xience V (Promus) Stent and 12.1 percent for the Taxus Stent*.

Stent thrombosis rates through one year were also low for both the Taxus
Stent (0.6 percent, 0.6 percent) and the Xience V (Promus) Stent (0.8 percent, 1.1 percent), using protocol and ARC definitions, respectively.

'The SPIRIT III one-year data reaffirms the proven long term outcomes of the
Taxus Stent,' said Paul LaViolette, chief operating officer of Boston
Scientific. 'We look forward to launching the Promus Stent in the USA, which will complement our paclitaxel-eluting Taxus Stent by offering physicians a deliverable Olimus option.'

The Promus Stent has CE Mark approval and is distributed in most European countries and other international markets. The Promus Stent is an investigational device in the USA and not yet approved for sale. It is currently under FDA review with an anticipated US launch in 2008. The safety and efficacy of the Taxus Express2 Stent System have not been established in patients with diabetes, long lesions and small vessels.

*Subsets were not designed for statistical comparisons and demonstrated the
above observational results.
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