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ARRIVE Registry Analysis Demonstrates Continued Safety and Efficacy of TAXUS(R) Stent in Complex Real-World Patients
Date:10/21/2007

NATICK, Mass. and WASHINGTON, Oct. 21 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced results from an analysis of nearly 7,000 patients from its TAXUS ARRIVE 1 and 2 registries, designed to assess the performance of the TAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System in "real-world" practice. The pooled ARRIVE data showed continued low incidences of adverse events and repeat revascularization through two years in complex patients treated with the TAXUS Express2 Stent. Analysis of the data was presented at the Cardiovascular Research Foundation's (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.

The ARRIVE registries enrolled 7,307 patients across the United States, including high-risk patients with complex lesions considered part of expanded use subgroups(i)(64 percent). The analysis included two-year data on 2,319 patients from ARRIVE 1 and one-year data on a pooled group of 6,979 patients from ARRIVE 1 and 2. The objective of the analysis was to determine if the safety and efficacy of the TAXUS Express2 Stent System demonstrated in simpler randomized clinical trials would translate to more complex populations treated in routine clinical practice.

One-year results from the 6,979 patients in the pooled data set showed event rates 3.5% for all death, 0.6% for Q-wave MI (myocardial infarction), and 5.1% for TAXUS-related target vessel revascularization (TVR, or re-treatment rate). Stent thrombosis per ARC definition definite plus probable in the pooled patient set was 1.7%. As expected, these safety outcomes at one year represent higher rates given the patient and lesion risk profiles and are in l
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