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TAXUS WOMAN Study Reports Positive Clinical Outcomes for the TAXUS(R) Drug-eluting Stent in Women
Date:9/5/2007

evaluated the performance of the TAXUS paclitaxel-eluting stent (PES) compared to a bare-metal stent (BMS) control in patients with coronary artery disease. The TAXUS WOMAN study analyzed pooled results of the women enrolled in these TAXUS trials and compared them with the corresponding endpoints in men.

Of the 3,445 patients enrolled in the TAXUS trials between June 2001 and March 2004, 955 (27.7%) were women. Of these women, 480 received PES and 475 received BMS. Of the 2,490 men enrolled, 1,238 received PES and 1,252 received BMS. As compared to men, women were older (mean age 65.4 +/- 10.9 years versus 61.0 +/- 10.4 years), had smaller body surface area (1.80 +/- 0.19m2 versus 2.05 +/- 0.20m2), had more diabetes (30.4% versus 21.0%), had more hypertension (78.0% versus 65.1%), had smaller vessels (pre-procedure reference vessel diameter 2.63 +/- 0.46mm versus 2.78 +/- 0.52mm), and had more history of coronary artery disease (62.2% versus 54.7%) (p for all <0.001). There were no other significant differences in baseline demographics, lesion or procedural characteristics between the PES and BMS groups in both genders.

Results show that the TAXUS Stent maintained its advantage in preventing repeat procedures compared to the bare-metal stent control, while showing no significant differences in outcomes based on gender. At one year, the unadjusted rate of target lesion revascularization (TLR) in the PES-treated group was 8.1 percent in women versus 6.7 percent in men (p=0.297), while in the BMS-treated group, the unadjusted TLR rate at one year was 17.5 percent in women versus 16.4 percent in men (p=0.613). At three years, the data showed continued low TLR rates in both women and men treated with PES (10.7% in women versus 8.8% in men, with no difference between men and women, p=0.301).

Comparable results in safety outcomes were seen for women, showing no differences in major adverse cardiac event (MACE) rates at one year. MACE rates in the PES grou
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SOURCE Boston Scientific Corporation
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