Boston Scientific (BSX) Reports Encouraging Data from PROMUS Element Study;
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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 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.
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