Results from TAXUS IV and V randomized clinical trials favor DES compared
to bare-metal stents
NATICK, Mass. and CHICAGO, April 1, 2008 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today welcomed favorable outcomes of one- year data from the Company's TAXUS IV and V randomized clinical trials in patients who received the TAXUS(R) Express(TM) Paclitaxel-Eluting Coronary Stent System compared to patients who received bare-metal stents (BMS). These results add to the growing body of evidence that paclitaxel-eluting stents are clinically beneficial over BMS even in the treatment of large vessels (greater than 3.5 mm), which typically have reduced restenosis risk compared to smaller diameter vessels. David A. Cox, M.D., FACC, presented the TAXUS IV and V results at the SCAI Annual Scientific Sessions in Partnership with the ACC/i2 Summit in Chicago.
In an analysis of TAXUS IV and V one-year clinical events, Dr. Cox reported that patients treated with the TAXUS Stent had significant reductions in one-year revascularization rates in both large and small diameter vessels compared to BMS. Although the absolute magnitude of the efficacy benefit was reduced in large diameter vessels, the relative reduction compared to BMS was maintained.
Results include outcomes from 2,458 patients divided into three groups according to maximal device diameter (defined as the diameter of the largest final 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, patients treated with the TAXUS Stent had lower rates of target lesion revascularization (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 >/=4.0mm group, suggesting that although the magnitude of the absolute TLR difference between TAXUS and BMS was reduced in larger diameter vessels, the relative reduction was actually greater. Significant reductions in target vessel revascularization (TVR) and MACE were also reported in both small and larger diameter vessels. There were no statistically significant differences in the incidences 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 vessels larger than 3.5mm. However, since larger vessels also surround significant amounts of heart muscle tissue, even small differences in clinical events between BMS and DES may be clinically relevant," said Dr. Cox. "Our analyses of TAXUS IV and V data clearly add to the growing body of evidence that DES still appear clinically beneficial over BMS in the treatment of large vessels."
The safety and effectiveness of the TAXUS Express Stent has not been established in lesions with reference vessel diameters >3.75mm.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.
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CONTACT: Paul Donovan
Boston Scientific Corporation
Boston Scientific Corporation
|SOURCE Boston Scientific Corporation|
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