Positive two-year results in study of Promus Element Cardiac Stent (Boston Scientific)

Two-year results from the PLATINUM Small Vessel study demonstrate that the 2.25 mm Promus Element (Everolimus-Eluting) Platinum Chromium Cardiac Stent System, from Boston Scientific, shows positive safety and effectiveness outcomes in treating de novo coronary lesions in small coronary vessels. The PLATINUM study met its primary endpoint of target lesion failure (TLF) at 12 months with a rate of 2.4 percent for the Promus Element Stent compared to a pre-specified goal of 21.1 percent based on outcomes for the 2.25 mm Taxus Express Paclitaxel-Eluting Stent. The TLF rate at two years is 4.7 percent with the Promus Element while the rate of target lesion revascularization (TLR) was 2.5 percent. According to lead investigator Ian Meredith, Director of MonashHeart at Monash Medical Centre in Melbourne, Australia, rates of other major adverse events remained low at two years, including cardiac death (2.3 percent) and myocardial infarction (0.0 percent). Data was presented today at the annual EuroPCR Scientific Program. The Promus Element stent received a CE Mark in October 2009 and the company plans to file in the US in 2012.