NATICK, Mass., June 12 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) welcomed results from the independent, multi-center STENT registry, the largest prospective, comparative real-world drug-eluting stent study ever reported. An analysis of data on diabetic patients revealed numerically favorable outcomes for the TAXUS Express2™ paclitaxel-eluting stent (PES) system compared to Johnson & Johnson's Cypher® sirolimus-eluting stent (SES) system in reducing mortality rates and overall major adverse cardiovascular events (MACE).
The STENT (Strategic Transcatheter Evaluation of New Therapies) registry included follow-up on 5,566 patients at eight coronary centers in the United States who received either a TAXUS stent system or a Cypher stent system, including 1,680 diabetic patients, nearly 500 of whom were insulin-treated diabetics. The new information included nine-month outcomes for all diabetic patients and nine-month death rates in insulin-treated patients.
Among the study's diabetic patients, the TAXUS patients generally had more complex lesions than Cypher patients as evidenced by a slightly higher ACC risk score, smaller vessels and longer lesions. Despite the higher complexity of the TAXUS patients, the TAXUS stent system demonstrated excellent outcomes in MACE when compared to the Cypher stent system in diabetic patients overall (6.8 percent versus 7.1 percent). In addition, the rate of death was lower for TAXUS (1.9 percent for TAXUS versus 3.4 percent for Cypher) without reaching statistical significance. Both groups presented excellent target vessel revascularization (TVR) and sub-acute thrombosis (SAT) rates. Among the non-insulin treated subset, the investigators did not observe any significant differences in MACE between the TAXUS and Cypher groups.
Updated data presented by Thomas Stuckey, M.D., at EuroPCR included more detail on the breakdown of cardiac and non-cardiac death rates in insulin-treated patients. Among insulin-treated patients, the overall rate of death also trended lower in the TAXUS group (2.1 percent for TAXUS [n=5] versus 5.7 percent for Cypher [n=15]). The rate of cardiac death was 1.3 percent for TAXUS (n=3) and 3.0 percent for Cypher (n=8), whereas the rate of non-cardiac death was 0.9 percent for TAXUS (n=2) and 2.7 percent for Cypher (n=7). Although none of the differences reached statistical significance, the investigators did note that the insulin treated subgroup demonstrated a trend favoring PES such as TAXUS over SES such as Cypher for late MACE, and that further studies need to be conducted to confirm these results.
"The latest analysis of this head-to-head study reinforces the benefits of TAXUS stents in complex lesions," said Dr. Stuckey. "Positive outcomes like these give physicians great confidence in the performance of these devices."
"We are very pleased with the latest results of this important study," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "Large, multi-center registries such as STENT are an excellent forum to provide sound, scientific trends for safety -- particularly in high-risk subgroups of patients. We look forward to the full results to better understand the trend favoring TAXUS stents."
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. Boston Scientific 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 new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
CONTACT: Milan Kofol 508-650-8569 Investor Relations Boston Scientific Corporation Paul Donovan 508-650-8541 Media Relations Boston Scientific Corporation
SOURCE: Boston Scientific Corporation
CONTACT: Milan Kofol, Investor Relations, +1-508-650-8569, or Paul
Donovan, Media Relations, +1-508-650-8541, both of Boston Scientific
Web site: http://www.bostonscientific.com/