NATICK, Mass./PRNewswire/ — 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, 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.”
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).
About Boston
Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical
devices that are used in a broad range of interventional medical specialties.
For more information, please visit: www.bostonscientific.com.
