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Taxus II Trial Results of Paclitaxel-eluting Stent Announced at Cardiology Meeting
TAXUS II is a 536-patient, 15-country, randomized, double-blind, controlled study of the safety and efficacy of a TAXUS(TM) paclitaxel-eluting coronary stent, in which two sequential cohorts of patients with standard risk, de novo coronary artery lesions were treated with different dose formulations.
BSC stated that at six months, TAXUS II reported an in-stent binary restenosis rate of 2.3 percent and an in-segment binary restenosis rate of 5.5 percent for the slow-release formulation cohort. The moderate-release formulation cohort reported a six-month in-stent binary restenosis rate of 4.7 percent and an in-segment binary restenosis rate of 8.6 percent. The rates for the control group at six months were 19 percent for in-stent binary restenosis and 22 percent for in-segment binary restenosis. In-segment includes the stent plus 5mm on either end of the stent. Both cohorts demonstrated an absence of edge effect, as stated by BSC.
Slow-release cohort: The slow-release formulation cohort reported an 8.5 percent MACE rate at six months with a 4.6 percent TLR rate. At 12 months, TAXUS II reported a 10.9 percent MACE rate with a 4.7 percent TLR rate. There were no additional TLRs reported from the slow-release cohort at 12 months.
Moderate-release cohort: The moderate-release formulation cohort reported a 7.8 percent MACE rate at six months with a 3.1 percent TLR rate. At 12 months, it reported a 9.9 percent MACE rate with a 3.8 percent TLR rate. There was only one additional TLR reported from the moderate-release formulation cohort at 12 months.
Combined, the control group reported a 21.7 percent MACE rate and 14.4 percent TLR rate at 12 months. The MACE-free survival rate difference between the control group and the TAXUS group increased over time, favoring the TAXUS group.
More than 95 percent of the patients enrolled in TAXUS II were included in the 12-month follow-up. The anti-platelet drug Plavix(R) was given for six months after the study stent was implanted. The 12-month results demonstrate a maintained benefit in TAXUS patients six months after the discontinuation of anti-platelet therapy.
The TAXUS clinical program is a series of studies designed to collect data on BSC's proprietary polymer-based, paclitaxel-eluting stent technology for reducing coronary restenosis, the growth of neointimal tissue within an artery after angioplasty and stenting. Prior studies have demonstrated promising results by dramatically reducing restenosis. Paclitaxel is a multi- functional microtubular inhibitor that controls platelets, smooth muscle cells and white blood cells, all of which are believed to contribute to restenosis. The proprietary polymer on the stent allows for controlled delivery of paclitaxel.
BSC acquired worldwide co-exclusive rights from Angiotech to use paclitaxel to coat its coronary stent products and other vascular and non- vascular products.
BSC launched the TAXUS(TM) product in Europe and other international markets in February. BSC plans to launch the product in the United States late this year.