Promus Element Stent Demonstrates Exceptional Safety and Effectiveness in PLATINUM Small Vessel Study
May 20, 2011 - Boston Scientific Corporation today announced 12-month results from its PLATINUM Small Vessel study, demonstrating excellent safety and effectiveness outcomes for the 2.25mm Promus Element Everolimus-Eluting Platinum Chromium Stent System in treating small vessel coronary disease. The study is a global, prospective, single-arm, subtrial of the PLATINUM clinical program. It compares the Promus Element Stent (2.25mm) in 94 patients with small vessels (greater than or equal to 2.25 to less than 2.50 mm reference vessel diameter and less than or equal to 28mm lesion length) to a pre-specified performance goal based on results from patients treated with the Taxus Express Paclitaxel-Eluting Stent.
Analysis of the data was presented at the annual EuroPCR Scientific Program in Paris by Ian T. Meredith, M.B.B.S., Ph.D., Professor of Cardiology and Medicine, Monash University, and Executive Director of Monash Cardiovascular Research Center, Monash Medical Centre, Clayton, Victoria, Australia, and co-principal investigator for the PLATINUM clinical program.
"The PLATINUM Small Vessel data demonstrate exceptionally low rates of revascularization, while reporting no myocardial infarction or stent thrombosis at one year in patients treated with the 2.25mm PROMUS Element Stent," said Meredith. "These results are impressive, especially considering the small vessel diameter in this patient population."
The PLATINUM Small Vessel study 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 in the per protocol population compared to a pre-specified performance goal of 21.1 percent (p<0.001) based on historical outcomes for the 2.25mm Taxus Express Stent. Components of TLF in the per protocol population included cardiac death related to the target vessel (2.4 percent), myocardial infarction related to the target vessel (MI, 0.0 percent) and ischemia-driven target lesion revascularization (TLR, 0.0 percent). Clinical outcome rates at 12 months in the intent-to-treat population were also low for cardiac death (3.3 percent), MI (0.0 percent), TLR (2.2 percent) and ARC definite/probable stent thrombosis (0.0 percent).
The PLATINUM clinical program is evaluating the safety and effectiveness of the Promus Element Stent in five multi-center studies totaling more than 1,800 patients, including a global, randomized, pivotal controlled trial in workhorse lesions, and single-arm studies evaluating small vessels, long lesions, pharmacokinetics, and quantitative coronary angiography and intravascular ultrasound data.
The Promus Element Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. It features an innovative PtCr alloy and new stent design to offer greater radial strength, exceptional deliverability and high visibility. The thin-strut stent is designed for improved conformability, minimal recoil and uniform lesion coverage and drug distribution. The advanced low-profile delivery system, coupled with the radiopacity, facilitates precise delivery of the stent across challenging lesions.
The Company anticipates FDA approval for the Promus Element Stent, including the 2.25 mm Promus Element Stent, in mid 2012. In the U.S., it is an investigational device, limited by applicable law to investigational use and not available for sale.
For more information: www.bostonscientific.com
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