Boston Scientific reports strong results for Taxus system

USA-based medical device developer and marketer Boston Scientific has reported strong results from its Taxus V clinical trial confirming the safety and efficacy of its Taxus Express2 paclitaxel-eluting coronary stent system for the treatment of coronary artery disease.

The randomized, double-blind trial enrolled 1,172 patients at 66 sites in the USA, assessing the safety and efficacy of a slow-release formulation of the paclitaxel-eluting coronary stent system in reducing restenosis in de novo lesions 10mm-46mm in length and 2.25mm-4.0mm in diameter.

The results supported its safety data as demonstrated by low overall rates of major adverse cardiac events including, death, myocardial infarction and target vessel revascularization, and stent thrombosis. The study reported a 15.0% overall MACE rate at nine months in the TAXUS group compared with 21.2% in the control bare-metal stent arm (p=0.0084), with all other factors, including cardiac death and MI, comparable to control (cardiac death was 0.5% in the TAXUS group versus 0.9% in the control group (p=0.7256), and MI was 5.4% in the TAXUS group vs 4.6% in the control arm (p=0.5853)).