Stent Registry Safety Data Favors Taxus(R) Over Cypher(R) In The Most Complex Diabetic Patients

Main Category: Diabetes
Article Date: 19 Mar 2006 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Boston Scientific Corporation (NYSE: BSX) today welcomed results from the independent, multi-center STENT registry, the largest prospective, comparative real world drug-eluting stent study ever reported. The study included follow-up on 5,566 patients at eight coronary centers in the United States who received either a TAXUS(R) Express2(R) paclitaxel-eluting coronary stent system or a Cypher(R) Stent system, including 1,182 diabetic patients, nearly 500 of whom were insulin-treated diabetics. Among insulin-treated diabetics, the results demonstrated a numerical trend toward improved survival and lower overall Major Adverse Cardiac Events (MACE) rate for patients who received a TAXUS stent system versus those who received a Cypher stent system. The results were presented at the American College of Cardiology's (ACC) inaugural "Innovation in Intervention: the i2 Summit" in Atlanta.

Among the study's diabetic patients, the TAXUS stent system was used in more complex lesions. The TAXUS patients had a slightly higher ACC risk score, smaller vessels and longer lesions than Cypher patients.

Despite the higher complexity of the TAXUS patients, the results favored the TAXUS stent system over the Cypher stent system in each of the study's MACE categories for insulin-treated diabetics. The MACE rate was a composite of death (2.1 percent for TAXUS versus 5.7 percent for Cypher), myocardial infarction (MI, or heart attack) (1.3 percent for TAXUS versus 1.9 percent for Cypher), and target vessel revascularization (TVR) (3.4 percent for TAXUS versus 4.2 percent for Cypher). The overall MACE rate also trended in favor of TAXUS (6.0 percent versus 10.7 percent for Cypher).

"In insulin-treated diabetics there is a slight separation in outcomes favoring the TAXUS stent system, although this did not reach statistical significance," said Charles Simonton, M.D., chairman of the executive steering committee for the STENT registry. "We plan continued enrollment to further investigate this apparent difference in outcomes."

"Previous studies have confirmed that paclitaxel and sirolimus have different mechanisms of action, and this study provides additional favorable data regarding the performance of paclitaxel in the treatment of insulin-treated diabetics," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "These data provide further support for our belief that the TAXUS stent system should be the preferred choice for the treatment of complex lesions." STENT (Strategic Transcatheter Evaluation of New Therapies) is the first U.S., multi-center, prospective registry initiated to evaluate the long-term efficacy and safety of paclitaxel- and sirolimus-eluting coronary stents among real-world patients and clinical situations.

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.

Forward-Looking Statements

This press release contains "forward-looking statements," including, among other statements, statements regarding the proposed business combination between Boston Scientific Corporation and Guidant Corporation, and the anticipated consequences and benefits of such transaction. Statements made in the future tense, and words such as "anticipate", "expect", "project", "believe", "plan", "estimate", "intend", "will", "may" and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, but are subject to certain risks and uncertainties, many of which are difficult to predict and are beyond the control of Boston Scientific or Guidant. Relevant risks and uncertainties include those referenced in Boston Scientific's and Guidant's filings with the Securities and Exchange Commission ("SEC") (which can be obtained as described in "Additional Information" below), and include: general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. Risks and uncertainties relating to the proposed transaction include: required regulatory approvals will not be obtained in a timely manner, if at all; the proposed transaction will not be consummated; the anticipated benefits of the proposed transaction will not be realized; and the integration of Guidant's operations with Boston Scientific will be materially delayed or will be more costly or difficult than expected. These risks and uncertainties could cause actual results to differ materially from those expressed in or implied by the forward-looking statements, and therefore should be carefully considered. Neither Boston Scientific nor Guidant assumes any obligation to update any forward-looking statements as a result of new information or future events or developments.

Additional Information

Boston Scientific and Guidant have filed a definitive prospectus/joint proxy statement with the SEC in connection with the proposed transaction. The material contained herein is not a substitute for the definitive prospectus/joint proxy statement or any other documents that Boston Scientific and Guidant have filed or will file with the SEC. Investors and security holders are urged to read the definitive prospectus/joint proxy statement and any other relevant documents filed or to be filed by Boston Scientific or Guidant, because they contain or will contain important information about the proposed transaction. The definitive prospectus/joint proxy statement is, and other documents filed or to be filed by Boston Scientific and Guidant with the SEC are or will be, available free of charge at the SEC's website (www.sec.gov) or from Boston Scientific by directing a request to Boston Scientific Corporation, One Boston Scientific Place, Natick, Massachusetts 01760-1537, Attention: Milan Kofol, Investor Relations, or from Guidant by directing a request to Guidant Corporation, 111 Monument Circle, 29th Floor, Indianapolis, Indiana 46204, Attention: Investor Relations.

Boston Scientific, Guidant and their respective directors, executive officers and other employees may be deemed to be participants in the solicitation of proxies from the security holders of Boston Scientific or Guidant in connection with the proposed transaction. Information about Boston Scientific's directors and executive officers is available in Boston Scientific's Annual Report on Form 10-K for the year ended December 31, 2005, and information about Guidant's directors and executive officers is available in Guidant's Annual Report on Form 10-K for the year ended December 31, 2005. Additional information about the interests of potential participants is included in the definitive prospectus/joint proxy statement referred to above.

http://www.bostonscientific.com