Taxus Express paclitaxel-eluting stent system: Additional Phase III data

One-year follow-up data from a subgroup of diabetic patients experiencing acute MI (AMI) in the single-blind, international Phase III HORIZONS AMI trial showed that Taxus Express2 paclitaxel-eluting stent system significantly reduced ischemia-driven TLR by 54% (p=0.03), binary in-stent restenosis by 81% (p<0.0001), and mean angiographic in-stent late loss by 66% (p<0.0001) compared with the bare-metal Express2 stent. The rates of MACE at 1 year were comparable between the 2 groups (10.2% vs. 12.5%, p=0.18), which Boston Scientific said is consistent with 1 year data from the overall patient population in the trial. Rates of death or repeat heart attack at 1 year (8.8% vs. 10.7%, p=0.56) and rates of stent thrombosis (3.1% vs. 4.5%, p=0.49) were also comparable between treatment groups. Boston Scientific also said it submitted an application to FDA to expand the indication of its Taxus Express and Taxus Liberte stents to include patients experiencing AMI. Data were presented at the American College of Cardiology meeting in Atlanta. Boston Scientific previously reported 1- and 2-year follow-up data from 3,006 evaluable patients in the trial (see BioCentury, Oct. 20, 2008 & Oct. 5, 2009). ...