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TAXUS(R) Express(R) Stent Shows Similarly Low Re-Intervention Rates in Patients with Diabetes Compared to Non-Diabetics in ARRIVE Registry Program
Date:5/13/2008

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In the ARRIVE registry analysis, the TAXUS Stent maintained comparable re-intervention rates in the diabetic and non-diabetic patient populations in ARRIVE 1 and 2. Cumulative two-year TVR rates, whether adjusted or unadjusted, were similar between diabetic and non-diabetic patients, respectively (9.8% vs. 9.0%, p=0.57, adjusted). Diabetic patients in the higher-risk subgroup actually had lower adjusted TVR rates than non-diabetic patients (9.5% vs. 11.3%, p=0.01). TAXUS Stent-related re-intervention of a target vessel (equivalent to target lesion revascularization, or TLR) was also similar between the patient groups (7.1% vs. 6.8%, p=0.31), despite the known higher risk for re-intervention in diabetic patients. In the higher-risk subgroup, two-year TLR was actually lower in diabetic patients after adjustment for baseline differences (7.3% vs. 8.7%, p=0.03).

Safety outcomes showed that diabetic patients treated with the TAXUS Stent in the ARRIVE registry had similar rates of MI (3.2% vs. 2.6%, p=0.29) and ARC Definite/Probable stent thrombosis (2.3% vs. 1.9%, p=0.27) compared to non-diabetic patients. The similarities held in both the higher- and lower-risk diabetic populations whether or not multivariate adjustment was used. The results also showed that both higher- and lower-risk diabetic patients had the expected increased overall adjusted two-year mortality rate compared to patients without diabetes (7.1% vs. 3.9%, p<0.001), as well as increased cardiac death (4.4% vs. 2.1%, p<0.001), reflecting the more advanced cardiac disease and increased comorbid risk factors associated with diabetes.

"Our extensive ARRIVE registries provide valuable insights into diabetic patients who are often at higher risk for adverse events and repeat stenting procedures," said Paul LaViolette, Chief Operating Officer at Boston Scientific. "The ARRIVE data demonstrated that the TAXUS Stent lessened the risk factor for clinical restenosis in the diabetic p
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SOURCE Boston Scientific Corporation
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