Boston Scientific, a developer, manufacturer and marketer of medical devices, has reported results from an analysis of one-year subset data from the Horizons AMI trial assessing the impact of diabetes on clinical and angiographic outcomes in heart attack patients treated with the Taxus Express2 Paclitaxel-Eluting Stent System or the Express bare-metal stent.
The results demonstrated that the Taxus Express Stent reduced ischemia-driven target lesion revascularization (TLR) at one year and binary in-stent restenosis at 13 months in diabetic patients experiencing an acute myocardial infarction (AMI, or heart attack) compared to an otherwise identical bare-metal control stent.
Boston Scientific has submitted an application to the FDA requesting expansion of the indications for use of the Taxus Express and Taxus Liberte Stents to include patients experiencing AMI.
Horizons AMI results demonstrated that the Taxus Express Stent reduced ischemia-driven TLR compared to the bare-metal control stent (BMS) in both diabetic patients and non-diabetic patients. Binary in-stent restenosis at 13 months was also reduced for diabetic patients treated with the Taxus Express Stent compared to BMS. Additionally, mean angiographic late loss at 13 months was reduced for diabetic patients treated with the Taxus Express Stent compared to BMS.
Keith Dawkins, senior vice president and chief medical officer at Boston Scientific, said: “Results from the Horizons AMI trial showed impressive efficacy benefits at one year for diabetic AMI patients treated with the Taxus Express Stent when compared to bare-metal stents. The data also showed comparable safety outcomes for Taxus Express and bare-metal stents in diabetic patients.
“This study provides important data to physicians regarding the use of drug-eluting stents in high-risk AMI patients, especially those with diabetes, during the early hours of a heart attack. We are proud to support this and other large clinical trials that provide the medical community data that can be used in combination with broader clinical judgment to develop optimal treatment strategies for challenging patient subsets.”