Healthcare Industry News: TAXUS IV
News Release - May 17, 2006
TAXUS(R) Coronary Stent System Cited by EuroIntervention for Superiority in Diabetic PatientsTAXUS benefits demonstrated in non-diabetic patient population carry over into insulin-treated diabetic patients
NATICK, Mass., and PARIS, May 17 (HSMN NewsFeed) -- EuroIntervention, the peer-reviewed medical journal affiliated with the Paris Course on Revascularization, today released an integrated analysis that further supports the strong performance of the TAXUS® paclitaxel-eluting coronary stent system for the treatment of coronary artery disease in diabetic patients. In the analysis, diabetic patients who received a TAXUS stent system had significantly lower rates of restenosis and repeat interventions than those who received a bare-metal stent. The study appears in the May edition of EuroIntervention, which is the official scientific journal of the annual Paris Course on Revascularization.
The authors stated in the article that "The TAXUS benefit provided for the high-risk diabetic population is in contrast to outcomes with bare-metal stents, which are worse for diabetic patients. The contrast between pro-stenotic forces with bare-metal stents and anti-restenotic effects for diabetes receiving TAXUS suggests that paclitaxel may also block restenotic pathways unique to the diabetic milieu. For diabetic patients, especially the high-risk insulin-treated group, this could dramatically improve clinical and angiographic outcomes and offer a less-invasive approach to a population with impaired wound healing."
According to the authors, a number of mechanistic factors may contribute to the observed TAXUS stent benefit. They state that the unique mechanism of action of paclitaxel, the drug used in TAXUS stents, supports their conclusion of emerging evidence of the excellent efficiency of TAXUS stents in insulin-dependent diabetics.
"We are pleased to see that, in this analysis, the well-established benefit of TAXUS stents in non-diabetic patients is carried over into the diabetic population, including the high-risk insulin-treated subset," said Jeff Goodman, Senior Vice President and President of International of Boston Scientific. "Diabetics account for almost one-quarter of patients undergoing treatment for coronary artery disease, so these findings are very encouraging."
The study is the first to use an integrated analysis of randomized data to examine aggregate results in a lower frequency but higher-risk diabetic population. Four TAXUS clinical trials (TAXUS II, TAXUS IV, TAXUS V and TAXUS VI) were included in the analysis, involving a total of 3,445 patients with coronary artery stenosis, 814 of whom had diabetes. Assessments of lesion characteristics showed that diabetic patients on average had more complex lesions than did non-diabetic patients. While diabetes has been identified as a strong predictor of restenosis after implantation of bare-metal stents, the angiographic and clinical results of this integrated analysis with similar outcomes independent of diabetic status suggest a significant advantage of the TAXUS stent system in diabetic patients, including the high risk insulin-treated subset.
The pooled clinical trial results at nine months reported a target lesion revascularization (TLR) rate of 5.4 in non-diabetic patients in the TAXUS group and a TLR rate of 5.8 percent in diabetic patients (insulin-treated) in the TAXUS group.
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.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, the regulatory approval process, reimbursement policies, commercialization of new technologies, litigation, the Company's overall business strategy and other factors described in the Company's filings with the Securities and Exchange Commission.
Source: Boston Scientific
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