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TAXUS II Data Show Paclitaxel Effective In Two Dose-Release Modalities

This article was originally published in The Gray Sheet

Executive Summary

Boston Scientific's plans to change the design of its upcoming TAXUS V study in the U.S. suggest that the company is leaning toward the slow-release formulation of paclitaxel for its drug-eluting stent development program

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ACC In Brief

TAXUS II: Anti-restenotic effects of paclitaxel are maintained beyond the cessation of clopidogrel therapy at six months post-implant, according to twelve-month data from Boston Scientific's trial of the Taxus paclitaxel-eluting stent, presented March 27 by Antonio Columbo, MD, Centro Cuore Columbus, Milan. Target lesion revascularization rates were 4.7% and 3.8% in the slow drug-release and moderate drug-release groups, respectively at 12 months, compared with 14.4% in the control group. One-year follow-up results represent a slight increase in each group over the six-month TLR rates presented in September at the annual TCT meeting in Washington, D.C. (1"The Gray Sheet" Sept. 30, 2002, p. 5)...

ACC In Brief

TAXUS II: Anti-restenotic effects of paclitaxel are maintained beyond the cessation of clopidogrel therapy at six months post-implant, according to twelve-month data from Boston Scientific's trial of the Taxus paclitaxel-eluting stent, presented March 27 by Antonio Columbo, MD, Centro Cuore Columbus, Milan. Target lesion revascularization rates were 4.7% and 3.8% in the slow drug-release and moderate drug-release groups, respectively at 12 months, compared with 14.4% in the control group. One-year follow-up results represent a slight increase in each group over the six-month TLR rates presented in September at the annual TCT meeting in Washington, D.C. (1"The Gray Sheet" Sept. 30, 2002, p. 5)...

American Heart Association Meeting In Brief

Taxus IV: Boston Scientific's Taxus paclitaxel-eluting stent is associated with a 3% MACE rate and 0.5% stent thrombosis according to complete 30-day safety data from the1,326-patient trial presented at the AHA annual meeting in Chicago Nov. 17. The company had presented data on 1,172 patients in September; however, the final 154 patients were considered more difficult to treat (1"The Gray Sheet" Sept. 30, 2002, p. 5). Also, 12-month follow-up results from the company's 61-patient Taxus I study of a slow-release paclitaxel-eluting stent showed zero restenosis and zero thrombosis at six months...

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