Interventional device developer Boston Scientific released the finalized five-year results from its Taxus II clinical trial. The Natick, Mass.-based company said the results demonstrate continued long-term safety and efficacy for the Taxus paclitaxel-eluting stent system, showing no additional stent thrombosis between years four and five, while the bare-metal stent control group experienced one stent thrombosis during this same period.
The trial, consisting of 536 patients from 15 countries, was designed to evaluate the safety and efficacy of the firm’s Taxus paclitaxel-eluting coronary stent.
Based on Boston Scientific’s results, the efficacy advantage of the Taxus stent was seen at six months and maintained through the five years following stent implantation, with the commercialized slow-release version of the Taxus stent reducing target lesion revascularization by 44 percent versus bare-metal stents. The same results showed that the safety of the Taxus stent was maintained with major adverse cardiac events for the Taxus SR stent showing a 35 percent reduction over the bare-metal control stent.
According to the trial’s results, the overall myocardial infarction rate for the Taxus SR stent was 4.7 percent as compared to 7.1 percent in the bare-metal group.