TAXUS WOMAN Study Reports Positive Clinical Outcomes For The TAXUS Drug-Eluting In Women

Boston Scientific Corporation (NYSE: BSX) announced results from the TAXUS WOMAN study, a gender specific analysis of the TAXUS II, IV, V and VI trials assessing the efficacy data of the TAXUS™ paclitaxel-eluting coronary stent in women undergoing coronary revascularization. The study found paclitaxel-eluting stents to have similar clinical outcomes in women and men, despite the higher risk profile in women patients. Results of the analysis of the TAXUS WOMAN study were released at the annual European Society of Cardiology Congress in Vienna, Austria.


"This study of data from the TAXUS trials offers encouraging news for women with coronary artery disease," said Ghada Mikhail, M.D., Consultant Cardiologist, St Mary's Hospital Trust, London, UK. "Previous trials and registries have demonstrated a less favorable clinical outcome in women compared to men when undergoing coronary revascularization with bare-metal stents. That difference has been previously explained by the smaller vessels and higher risk profile seen in women. These data show, however, that the TAXUS paclitaxel-eluting coronary stent works equally well in women, maintaining its anti-restenotic efficacy advantages and positive safety profile relative to bare-metal stents."


"Heart disease is the number one cause of death among women in the United States, and more women than men die from cardiovascular disease each year," said Hank Kucheman, Senior Vice President and Group President, Interventional Cardiology. "The findings of the TAXUS WOMAN study show the clear and sustained benefit of the TAXUS stent in women with heart disease."


The TAXUS II, IV, V and VI trials 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 analysed 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