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Study Finds Taxus(R) Drug-Eluting Stent Beneficial in Treatment of Large Vessels

Wednesday, April 2, 2008 General News
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NATICK, Mass. and CHICAGO, April 1, 2008 BostonScientific Corporation (NYSE: BSX) today welcomed favorable outcomes of one-year data from the Company's TAXUS IV and V randomized clinical trials inpatients who received the TAXUS(R) Express(TM) Paclitaxel-Eluting CoronaryStent System compared to patients who received bare-metal stents (BMS). Theseresults add to the growing body of evidence that paclitaxel-eluting stents areclinically beneficial over BMS even in the treatment of large vessels (greaterthan 3.5 mm), which typically have reduced restenosis risk compared to smallerdiameter vessels. David A. Cox, M.D., FACC, presented the TAXUS IV and Vresults at the SCAI Annual Scientific Sessions in Partnership with the ACC/i2Summit in Chicago.
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In an analysis of TAXUS IV and V one-year clinical events, Dr. Coxreported that patients treated with the TAXUS Stent had significant reductionsin one-year revascularization rates in both large and small diameter vesselscompared to BMS. Although the absolute magnitude of the efficacy benefit wasreduced in large diameter vessels, the relative reduction compared to BMS wasmaintained.
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Results include outcomes from 2,458 patients divided into three groupsaccording to maximal device diameter (defined as the diameter of the largestfinal stent or post-dilatation balloon utilized): <3.5 mm (n=1,528 patients),>/=3.5mm-<4.0mm (n=655), and >/=4.0mm (n=275). Compared to BMS, patientstreated with the TAXUS Stent had lower rates of target lesionrevascularization (TLR) at all device diameters: 9.7% vs. 20.4% (p<0.001) for<3.5mm, 4.5% vs. 13.5% (p<0.001) for >/=3.5mm-<4.0mm, and 1.6% vs. 6.5%(p<0.05) for >4.0mm. These rates correspond to reductions of 52.5% for the<3.5mm group, 66.7% for the >/=3.5mm-<4.0mm group, and 75.4% for the >/=4.0mmgroup, suggesting that although the magnitude of the absolute TLR differencebetween TAXUS and BMS was reduced in larger diameter vessels, the relativereduction was actually greater. Significant reductions in target vesselrevascularization (TVR) and MACE were also reported in both small and largerdiameter vessels. There were no statistically significant differences in theincidences of cardiac death, myocardial infarction or stent thrombosis.

"The risk for restenosis with BMS is generally decreased in large vessels,prompting some interventional cardiologists to choose BMS over DES in vesselslarger than 3.5mm. However, since larger vessels also surround significantamounts of heart muscle tissue, even small differences in clinical eventsbetween BMS and DES may be clinically relevant," said Dr. Cox. "Our analysesof TAXUS IV and V data clearly add to the growing body of evidence that DESstill appear clinically beneficial over BMS in the treatment of largevessels."

The safety and effectiveness of the TAXUS Express Stent has not beenestablished in lesions with reference vessel diameters >3.75mm.

Boston Scientific is a worldwide developer, manufacturer and marketer ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visit:http://www.bostonscientific.com.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaningof Section 21E of the Securities Exchange Act of 1934. Forward-lookingstatements may be identified by words like "anticipate," "expect," "project,""believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates usinginformation available to us at the time and are not intended to be guaranteesof future events or performance. These forward-looking statements include,among other things, statements regarding clinical trials, regulatory approvals,competitive offerings, product performance and our market position. If ourunderlying assumptio
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