Healthcare Industry News: ARRIVE 1
News Release - March 25, 2007
Boston Scientific Announces Results From Arrive 1 Registry Supporting Positive Performance of TAXUS(R) Stent System in Complex PatientsTwo-year review of TAXUS Stent safety data presented at ACC
NATICK, Mass. and NEW ORLEANS, March 25 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced two-year results from its ARRIVE 1 registry and the combined one-year results of the ARRIVE 1 and ARRIVE 2 registries, which study the safety of the TAXUS® Express(2)(TM) paclitaxel-eluting coronary stent system in "real-world" patients. The ARRIVE registries enrolled more than 7,300 patients across the United States, including patients with complex lesions(1) (65 percent) and diabetes(2) (31.5 percent). The Company made the announcement at the annual American College of Cardiology Scientific Session in New Orleans.
"Given the substantial proportion of high-risk patients and lesions, the ARRIVE 1 two-year data are noteworthy and provide additional support for the consistent performance of the TAXUS stent system in real-world patients," said John M. Lasala, M.D., Ph.D., of Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis, and the study's Co-Principal Investigator.
Two-year results from the 2,487 patients in ARRIVE 1 demonstrated a TAXUS- related cardiac event rate of 9.9 percent, including cardiac death (1.3 percent), myocardial infarction (2.4 percent) and target vessel revascularization (TVR, or re-treatment rate) (8.2 percent). Stent thrombosis(3) was 2.9 percent, and death from all causes (cardiac and non- cardiac) was 6.0 percent.
In the medication-requiring diabetic sub-population, the TAXUS-related cardiac event rate at two years was 11.4 percent, including cardiac death (1.9 percent), myocardial infarction (3.5 percent) and TVR (8.7 percent). The non- diabetic subgroup reported a TAXUS-related cardiac event rate of 9.1 percent, including cardiac death (0.9 percent), myocardial infarction (2.0 percent) and TVR (7.9 percent). The stent thrombosis rate for medication-requiring diabetics was 3.8 percent compared to non-diabetics at 2.5 percent. All cause death for the medication-requiring diabetic subgroup was 8.0 percent compared to 4.9 percent for the non-diabetic population.
"We are very pleased that the ARRIVE 1 data provide further support for the excellent results obtained with the TAXUS stent system in real-world patients," said Hank Kucheman, Senior Vice President and Group President of Boston Scientific's Interventional Cardiology business.
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: 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 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.
Source: Boston Scientific
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