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Real-World Data from ARRIVE Registries Show Favorable Outcomes for TAXUS(R) Express(TM) Stent
Date:3/29/2008

he ARRIVE 1 and 2 registries, including those with long lesions, bifurcations, graft stenting, significant calcifications, and multi-vessel stenting. There were no differences in two-year safety rates (all death, Q-wave myocardial infarction (MI), or ARC definite/probable stent thrombosis) between ARRIVE simple-use patients and the clinical trial cohort. Adverse event rates at one year were expectedly higher for expanded-use versus simple-use ARRIVE patients, and included all death (4.2% vs. 2.3%, respectively), all MI (1.8% vs. 1.2%), target lesion revascularization (TLR) (6.2% vs. 3.4%), and ARC stent thrombosis (2.2% vs. 0.9%). 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. Overall rates for TAXUS Stent- related events in ARRIVE were within expected ranges given the patient complexity.

Through two years, medically treated diabetic patients had a higher rate of all death (9.7% vs. 5.1%, p<0.0001) compared to non-diabetic patients but similar rates of TLR (8.1% vs. 7.7%, p=0.63), MI (2.5% vs. 2.2%, p=0.40), and ARC stent thrombosis (3.0% vs. 2.4%, p=0.13). Patients with graft stenting or stenting of bifurcation lesions had significantly higher rates of ARC stent thrombosis and TLR through two years, as expected given the complexity of the lesions treated.

"Our ARRIVE registry data provide valuable insights into the benefits of the TAXUS Stent in treating the broad spectrum of disease seen in real-world interventional practice," said Paul LaViolette, Chief Operating Officer at Boston Scientific. "The analysis reinforces data observed in our randomized clinical trials, showing positive long-term performance of the TAXUS Stent."

The safety and effectiveness of the TAXUS Express Stent has not been established in lesions longer than 28mm, bifurcations, saphenous vein grafts, multi-vessel stenting or diabetics.

Boston Scientif
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SOURCE Boston Scientific Corporation
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