Boston Scientific's PROMUS Element(TM) Platinum Chromium Stent System Demonstrates Comparable Safety and Effectiveness Outcomes Versus Leading Drug-eluting Stent in Platinum Workhorse Trial
By Boston Scientific Corporation, PRNEMonday, April 4, 2011
Reduction of Geographic Miss and Bail-out Stenting Observed With Highly Visible PROMUS Element Stent
NATICK, Massachusetts and NEW ORLEANS, April 5, 2011 - Boston Scientific Corporation (NYSE: BSX) today announced
12-month results from the pivotal PLATINUM Workhorse trial comparing the
safety and effectiveness of the PROMUS Element(TM) Everolimus-Eluting
Platinum Chromium (PtCr) Coronary Stent System to the PROMUS(R)
Everolimus-Eluting Coronary Stent System. The trial demonstrated the clinical
non-inferiority of the PROMUS Element Stent in comparison to the PROMUS Stent
in treating de novo coronary artery lesions while showing a procedural
benefit of reduced rates of unplanned (bail-out or emergency) stenting.
Results were presented during a late-breaking trial session at
the American College of Cardiology Annual Scientific Sessions by Gregg W.
Stone, M.D., Professor of Medicine and Director of Research and Education at
the Center for Interventional Vascular Therapy at Columbia University Medical
Center/New York-Presbyterian Hospital and Global Principal Investigator of
the trial. Results were also published concurrently in the online version of
the Journal of American College of Cardiology (JACC) and will be available in
the April 19 print edition.
"The PROMUS Element Platinum Chromium Stent met the primary
non-inferiority endpoint of target lesion failure at one year compared to the
PROMUS Stent while demonstrating excellent safety and effectiveness with low
rates of cardiac death, myocardial infarction, stent thrombosis and
revascularization," said Dr. Stone. "The remarkably low rates of stent
thrombosis and target lesion revascularization at one year confirm the
successful transfer of the favorable outcomes associated with everolimus to
the novel platinum chromium stent design."
The primary endpoint of non-inferiority for the PROMUS Element
Stent compared to the PROMUS Stent was met with a 12-month target lesion
failure (TLF) rate in the per protocol population of 3.4 percent versus 2.9
percent, respectively (pNI=0.001). No statistically significant differences
in TLF components were observed between the two stents. In the
intention-to-treat population, TLF (3.5 percent vs. 3.2 percent, p=0.72),
cardiac death related to the target vessel (0.8 percent vs. 0.4 percent,
p=0.51), myocardial infarction (MI) related to the target vessel (0.8 percent
vs. 1.6 percent, p=0.14) and ischemia-driven target lesion revascularization
(TLR, 1.9 percent vs. 1.9 percent, p=0.96) were all similar. Low rates of
target vessel revascularization (TVR, 2.7 percent vs. 2.9 percent, p=0.83)
and stent thrombosis (ARC definite/probable, 0.4 percent vs. 0.4 percent,
p=0.99) were also observed at 12 months for the PROMUS Element and PROMUS
Stents.
Both stents achieved high rates of technical success (99.4
percent for PROMUS Element vs. 98.8 percent for PROMUS, p=0.14) indicating
successful delivery and deployment of the stent to the target vessel. The
PROMUS Element Stent achieved a significant reduction in unplanned (bail-out
or emergency) stenting (5.9 percent vs. 9.8 percent, p=0.004), including a
significantly lower rate of inadequate lesion coverage (1.4 percent vs. 3.4
percent, p=0.01). These clinical observations are consistent with the results
of comparative bench and animal studies, which have demonstrated the enhanced
visibility of the PROMUS Element Stent relative to the PROMUS Stent.
"We are extremely pleased that the highly opaque platinum
chromium alloy PROMUS Element Stent significantly reduced both inadequate
lesion coverage ('geographic miss') and the need for unplanned (bail-out)
stenting," said Hank Kucheman, Executive Vice President and Group President,
Cardiology, Rhythm and Vascular for Boston Scientific. "The PROMUS Element
Stent offers interventional cardiologists a true next-generation stenting
option for patients with coronary artery disease."
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 strength,
enhanced deliverability and exceptional 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
facilitates precise delivery of the stent across challenging lesions.
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 single-arm studies evaluating
small vessels, long lesions, pharmacokinetics, and quantitative coronary
angiography and intravascular ultrasound data. PLATINUM Workhorse is a
global, randomized, pivotal controlled trial designed to support U.S. Food
and Drug Administration (FDA) approval of the PROMUS Element Stent System.
The trial enrolled 1,530 patients with up to two de novo lesions at 132 sites
worldwide, and completed enrollment in September 2009.
The PERSEUS clinical program compared the ION (TAXUS Element)
Stent to prior-generation Boston Scientific stents in more than 1,600
patients in two parallel trials at 90 centers worldwide. The PERSEUS
Workhorse trial reported 12-month results in March 2010, demonstrating
positive safety and efficacy outcomes in workhorse lesions for the ION Stent
System compared to the TAXUS(R) Express(2)(R) Stent System.
The Company anticipates FDA approval for the PROMUS Element
Stent in mid 2012. In the U.S., the PROMUS Element Stent is an
investigational device, limited by applicable law to investigational use only
and not available for sale.
In the U.S., the TAXUS Element Stent System will be
commercialized as the ION(TM) Paclitaxel-Eluting Platinum Chromium Coronary
Stent System. In the U.S., the ION Stent System is an investigational device,
limited by applicable law to investigational use only and not available for
sale. The Company expects to launch the ION Stent System in the United States
by mid-2011. The TAXUS Element Stent System received CE Mark approval in May
2010.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and
marketer of medical devices whose products are used in a broad range of
interventional medical specialties. For more information, please visit:
www.bostonscientific.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and Section 21E of
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among other things, statements regarding new product launches and launch
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CONTACT: Erik Kopp +1-508-650-8660 (office) Media Relations Boston Scientific Corporation erik.kopp@bsci.com Sean Wirtjes +1-508-652-5305 (office) Investor Relations Boston Scientific Corporation investor_relations@bsci.com
CONTACT: Erik Kopp, +1-508-650-8660 (office), Media Relations, Boston Scientific Corporation,
erik.kopp at bsci.com; Sean Wirtjes, +1-508-652-5305 (office), Investor Relations,
Boston Scientific Corporation, investor_relations at bsci.com
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