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ARRIVE Registry Analysis Identifies Predictors of Stent Thrombosis,in Real-World Use of Drug-Eluting Stents

Study highlights importance of antiplatelet therapy compliance

NATICK, Mass. and BARCELONA, Spain, May 22, 2007 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today announced results from an analysis of more than 7,000 patients from its 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 objective of the analysis was to identify baseline predictors of stent thrombosis (blood clots) at one and two years post-implant to better guide physician recommendations for patient therapy following treatment with drug-eluting stents. Analysis of the data was presented by David Dobies, M.D., F.A.C.C., at the annual Paris Course on Revascularization (EuroPCR) in Barcelona.

The analysis included two-year data on 2,487 patients from ARRIVE 1 and one-year data on a pooled group of 7,307 patients from ARRIVE 1 and 2. More than 30 baseline characteristics were assessed as predictors of stent thrombosis at various time periods up to two years using the ARC (Academic Research Consortium) definition of "definite plus probable, total." Stent thrombosis is a rare but serious adverse event that can occur with both bare- metal and drug-eluting stents (DES) at any time following stent implantation but often occurs within the first 30 days. Risk factors associated with DES stent thrombosis include acute coronary syndrome, stent length, stent underexpansion and non-compliance with antiplatelet therapy. Predictive analyses for stent thrombosis can be limited by low event numbers, however, the size of the ARRIVE program allowed identification of low-frequency TAXUS stent-related clinical events.

Patients in the study were prescribed antiplatelet therapy in accordance with the TAXUS Stent label, including indefinite aspirin therapy and six months of clopidogrel or ticlopidine. At one year, 92.8 percent of patien
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