Diabetics and drug-eluting stents
Boston Scientific Corporation has announced results from a pooled analysis of patients from its TAXUS IV and TAXUS V randomised clinical trials to compare the safety and efficacy of the TAXUS Express Paclitaxel-Eluting Coronary Stent System in diabetic versus non-diabetic patients.
The company reports that the results demonstrate that despite the known increased rates of mortality and restenosis for diabetics versus non-diabetics in patients with cardiovascular disease, the TAXUS Stent had comparable levels of late loss and target lesion revascularisation (TLR) across these patient populations. ‘The study also showed no significant differences in target vessel revascularisation (TVR), stent thrombosis, or myocardial infarction (MI), after adjustments were made for differences in other baseline characteristics between patients with or without diabetes.’ Analysis of the data was presented by Gregg W Stone MD, of the Columbia University Medical Centre, New York, at the SCAI Annual Scientific Sessions in Partnership with the ACC/i2 Summit in Chicago.
The pooled analysis included angiographic outcomes at nine months and clinical outcomes at three years among 338 diabetic patients and 901 non-diabetic patients treated with the TAXUS Stent from the TAXUS IV and V clinical trials. Nine-month angiographic outcomes showed equivalent in-segment late loss (0.27mm vs. 0.31mm, p=0.28) and binary restenosis (14.3% vs. 15.1%, p=0.83) in diabetics and non-diabetics, respectively.
‘The TAXUS IV/V diabetic subset data indicated that the TAXUS Stent mitigated the impact of diabetes as a risk factor for restenosis following stenting procedures in the patients studied,’ Dr Stone said. ‘Diabetic patients treated with TAXUS Stents compared with bare-metal stents had significantly improved event-free survival, particularly important in high-risk patients with diabetes.’
30.04.2008
