EuroPCR: PROMUS Element™ Stent Demonstrates Excellent Long-Term Safety and Effectiveness in PLATINUM Small Vessel Study
Two-year Clinical Data Demonstrate Low Adverse Event Rates, Including No Myocardial Infarction or Stent Thrombosis, for the Boston Scientific 2.25 mm PROMUS Element Platinum Chromium Stent
NATICK, Mass., May 18, 2012 — Boston Scientific Corporation 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, MD, 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."
Boston Scientific received CE Mark approval for the Promus Element Stent System in 2009 and for the Promus Element Plus Stent System in 2011. In the U.S., the Promus Element Plus Stent System was approved by the Food and Drug Administration in 2011. The Promus Element Stent, part of the Promus Element Stent System and the Promus Element Plus Stent System, employs a proprietary PtCr alloy designed specifically for coronary stenting, which enables enhanced visibility, less recoil, excellent conformability and higher radial strength. The Promus Element Plus Stent System employs an advanced low-profile delivery system, designed to facilitate precise delivery of the stent across challenging lesions.
Xience is a trademark of the Abbott Laboratories group of companies. Promus is a private-labeled Xience V everolimus-eluting stent system manufactured by Abbott and distributed by Boston Scientific.
About the PLATINUM Small Vessel Study
The PLATINUM Small Vessel study is a prospective, multicenter, single-arm, subtrial of the PLATINUM clinical program designed to evaluate the safety and effectiveness of the Promus Element Stent (2.25 mm) for the treatment of de novo coronary lesions in patients with small vessels (greater than or equal to 2.25 to <2.50 mm reference vessel diameter and less than or equal to 28 mm lesion length).