May 19 2012
Boston Scientific Corporation (NYSE: BSX) announces two-year results from the PLATINUM Small Vessel study, demonstrating excellent safety and effectiveness outcomes for the 2.25 mm PROMUS Element™ Everolimus-Eluting Platinum Chromium (PtCr) Stent System in treating de novo coronary lesions in small coronary vessels. Analysis of the data was presented today at the annual EuroPCR Scientific Program in Paris.
"The PLATINUM Small Vessel data continue to demonstrate very low revascularization rates, with no myocardial infarction or stent thrombosis through two years of follow up in patients treated with the 2.25 mm PROMUS Element Stent," said Ian Meredith, Professor and Director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, and co-principal investigator for the PLATINUM clinical program. "These long-term results are impressive, especially considering the small vessel diameters that were evaluated in this study."
The PLATINUM Small Vessel study previously met its primary endpoint of target lesion failure (TLF) at 12 months with a rate of 2.4 percent for the 2.25 mm PROMUS Element Stent compared to a pre-specified performance goal of 21.1 percent (p<0.001) based on historical outcomes for the 2.25 mm TAXUS® Express® Paclitaxel-Eluting Stent. The TLF rate at two years was 4.7 percent with the 2.25 mm PROMUS Element Stent while the rate of target lesion revascularization (TLR) was 2.5 percent. Rates of other major adverse events remained low in patients treated with study stents at two years, including cardiac death (2.3 percent), myocardial infarction (0.0 percent) and Academic Research Consortium (ARC) definite/probable stent thrombosis (0.0 percent). There were no deaths between 1 and 2 years for patients treated with the 2.25 mm PROMUS Element Stent.
"The PLATINUM Small Vessel data build on the positive long-term outcomes from the PLATINUM Workhorse trial, which reported excellent safety and effectiveness of the PROMUS Element Stent in workhorse lesions and demonstrated superior efficacy compared to the XIENCE V® (PROMUS®) Stent in a landmark analysis of revascularization outcomes from year one to year two," said Keith D. Dawkins, M.D., global chief medical officer for Boston Scientific. "The results demonstrate a highly effective platinum chromium small vessel stent platform with an excellent safety profile. This study of the 2.25 mm PROMUS Element Stent reconfirms our commitment to providing a complete range of stenting solutions and sizes for physicians and their patients."
SOURCE Boston Scientific Corporation