NATICK, Mass. and WASHINGTON, Oct. 12 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced results from an analysis of nearly 7,500 patients from its TAXUS ARRIVE 1 and 2 registries, which are designed to confirm the performance of the TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System in real-world practice. The two-year pooled ARRIVE data showed that the TAXUS Stent reduced clinical restenosis in patients with diabetes as effectively as in patients without diabetes, with no incremental risk of myocardial infarction (MI) or stent thrombosis. Analysis of the data was presented by John M. Lasala, M.D., Ph.D., F.A.C.C., at the Cardiovascular Research Foundation's (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
"The ARRIVE diabetic subset data demonstrated that the TAXUS Stent mitigated the adverse effect of diabetes as a risk factor for restenosis and repeat procedures in the patients studied," said Dr. Lasala, Professor of Medicine, Washington University School of Medicine in St. Louis. "While the diabetic patients had more cardiac risk factors, comorbidity and higher mortality than non-diabetics, the rates of reintervention, MI and stent thrombosis in the ARRIVE 1 and 2 registries were similar in both groups, regardless of risk profile."
The pooled analysis included two-year data on 2,112 medication-requiring diabetic patients and 5,380 non-diabetic patients from the ARRIVE registry program. The population was further segmented into a higher-risk group(1) and a lower-risk group. Due to a significant increase in comorbid risk factors in patients with diabetes compared to non-diabetics, multivariate modeling and analysis was used to allow for adjustment of baseline differences (other than the presence of diabetes) between the two groups. Multivariate analysis was also used to determine predictors of target lesion revascularization (TLR) and mortality.
In the pooled ARRIVE 1 and 2 registry analysis, the TAXUS Stent maintained comparable re-intervention rates in the diabetic and non-diabetic patient populations. Cumulative two-year TLR rates, whether adjusted (7.1% vs. 6.8%, p=0.41) or unadjusted (8.2% vs. 7.7%, p=0.59), were similar between diabetic and non-diabetic patients, respectively. Diabetic patients in the higher-risk subgroup actually had lower adjusted TLR rates than non-diabetic patients (7.2% vs. 8.6%, p=0.03). Analysis of multivariate predictors showed that diabetes is not a significant predictor of TLR at two years in patients treated with the TAXUS Stent.
Safety outcomes at two years showed that diabetic patients treated with the TAXUS Stent in the ARRIVE registry had similar rates of MI (3.1% vs. 2.5%, p=0.35, adjusted) and ARC definite/probable stent thrombosis (2.3% vs. 1.9%, p=0.34, adjusted) compared to non-diabetic patients, whether or not multivariate adjustment was used. The results also showed that diabetic patients had the expected increase in two-year mortality compared to patients without diabetes (7.0% vs. 3.9%, p<0.001, adjusted), as well as increased cardiac death (4.3% vs. 2.1%, p<0.001), reflecting the more advanced cardiac disease and increased comorbid risk factors associated with diabetes. While diabetes was shown to be an independent predictor of mortality at two years in the overall study sample, the strongest predictors of two-year mortality in both the overall sample and in diabetic patients were renal disease, treated left main disease and congestive heart failure.
"Our extensive ARRIVE registries provide valuable insights into the benefits of the TAXUS Stent in treating diabetic patients who are often at higher risk for adverse events and repeat stenting procedures," said Donald S. Baim, M.D., Chief Medical and Scientific Officer at Boston Scientific. "The ARRIVE data demonstrated that the TAXUS Stent lessened the risk factor for clinical restenosis in the diabetic patients studied."
The growing diabetic subset accounts for more than one-quarter of all coronary interventional procedures in the United States. Diabetes is generally associated with an increased risk of overall mortality and cardiovascular events. In addition, patients with diabetes are more likely than non-diabetic patients to require repeat procedures due to a higher incidence of restenosis following angioplasty and stenting.
In the United States, the TAXUS Stent is not specifically indicated for use in patients with diabetes.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com/.
(1) The higher-risk group includes the following patient and lesion characteristics: vein graft, left main, bifurcation, severe calcification, cardiogenic shock, direct stenting of total occlusion, thrombus, severely tortuous vessels, total stent length >64mm, which are outside approved indications. The lower-risk group excludes these patient and lesion characteristics. Indications, contraindications, warnings, precautions and instructions for use can be found in the product labeling supplied with each device. Cautionary Statement Regarding Forward-Looking Statements
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CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation
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