April 1, 2008 – Boston Scientific announced results from an analysis two-year data from more than 7,000 patients in the TAXUS ARRIVE Registry program, a study designed to evaluate the safety performance of the TAXUS Express Paclitaxel-Eluting Coronary Stent System in patients treated in “real-world” practice.
Outcomes through the two-year period in the simple-use (single vessel/stent) patient group confirmed the favorable results seen in similar patient enrolled in previous TAXUS randomized clinical trials (the clinical trial cohort).
The pooled analysis included two-year outcomes for 7.033 patients in the ARRIVE 1 and 2 registries, including those with long lesions, bifurcations, graft stenting, significant calcifications and multi-vessel stenting. There were no reported differences in two-year safety rates between ARRIVE simple-use patients and the clinical trial cohort. Adverse event rates at one year were higher for expanded-use versus simple-use ARRIVE patients, and included all death, all MI, target lesion revascularization and ARC stent thrombosis. However, TAXUS Stent-related adverse event rates during the second year of follow-up were lower for both expanded-use and simple-use patients than in the first year.
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