MARLBOROUGH, Mass.,
May 19, 2015 /PRNewswire/
-- Boston Scientific (NYSE: BSX) reported positive, long-term
data from the EVOLVE Trial of the SYNERGY™ Everolimus-Eluting
Bioabsorbable Polymer Platinum Chromium Coronary Stent System, with
no new major adverse cardiac events reported between years three
and four. The study results were presented for the first time
today at EuroPCR 2015 by Professor Ian
Meredith, director of MonashHeart, at Monash Medical Centre
in Melbourne, Australia.
Findings from year four of the EVOLVE Trial include the
following key performance measures:
- the target lesion revascularization (TLR) rate was 1.1 percent
compared to 6.1 percent for the PROMUS Element™ Plus Stent System
(p=0.07); and
- no definite or probable stent thrombosis (ST) was
observed.
"These long-term data from the EVOLVE Trial are quite important
as they highlight the sustained safety and performance of the
SYNERGY Stent," said Professor Meredith. "We continue to be
encouraged by the consistently positive clinical data that point to
the potential for improved healing with the SYNERGY Stent compared
to durable polymer drug-eluting stents."
The EVOLVE Trial is the first human use, prospective,
randomized, single-blind study evaluating the non-inferiority of
the SYNERGY Stent, which employs an ultrathin bioabsorbable polymer
coating applied to the abluminal (outer) surface of the stent.
The comparator, the Boston Scientific PROMUS Element Plus
Stent System, utilizes a durable polymer coating applied to the
entire stent (inner and outer) surface. EVOLVE is the first
in a continuing cadence of clinical trials evaluating the
performance of the SYNERGY Stent in a range of patients.
In addition to these long-term data from the EVOLVE Trial,
one-year findings from the EVOLVE II pivotal trial of 466 patients
with diabetes treated with the SYNERGY Stent were presented today
by Stephan Windecker M.D., chief of
cardiology and head of invasive cardiology at the Swiss
Cardiovascular Center in Bern,
Switzerland. Patients with diabetes face an increased
risk of heart disease, stroke and myocardial
infarction.[1] The data presented for patients
with diabetes include the following:
- the TLR rate was 4.4 percent; and
- definite/probable ST was 1.1 percent at one year, with no
definite/probable ST events after the first week post percutaneous
coronary intervention (PCI).
The EVOLVE II Trial includes a global, multi-center, randomized,
single-blind, non-inferiority pivotal trial designed to evaluate
the safety and performance of the SYNERGY Stent System compared to
the durable polymer PROMUS Element Plus Stent System. The
trial enrolled 1,684 patients in 125 sites worldwide. The
EVOLVE II Trial is part of a rigorous clinical program designed to
support the submission for U.S. Food and Drug Administration (FDA)
and Japanese Ministry of Health, Labor and Welfare (MHLW) approval
of the SYNERGY Stent.
The EVOLVE II Trial also includes a non-randomized, single-arm
diabetes study. The EVOLVE II Diabetes Substudy pooled
patients with diabetes randomized to the SYNERGY arm in the EVOLVE
II pivotal trial with patients enrolled in the non-randomized
single-arm diabetes study as pre-specified in the study protocol.
Patients in the EVOLVE II Trial demonstrated clinical and
angiographic complexity to a degree not observed in prior U.S.
pivotal trials for drug-eluting stents (DES). More than 25
percent of patients had non-ST elevation myocardial infarction
(NSTEMI) and approximately 75 percent of patients had AHA/ACC class
B2/C coronary lesions. As previously reported, EVOLVE II met
its primary endpoint, demonstrating non-inferiority of SYNERGY
versus the PROMUS Element Plus Stent for 12-month target lesion
failure in the overall patient population.
"These long-term data, combined with the data for a particularly
challenging group of patients—those with co-morbid
diabetes—reinforce our belief in the difference the SYNERGY
Bioabsorbable Polymer Stent can make for physicians and their
patients," said Kevin Ballinger,
president, Interventional Cardiology, Boston Scientific. "The
SYNERGY Stent is designed to provide early healing and freedom from
long-term polymer exposure, and we are confident that clinical
studies and experience will continue to demonstrate excellent
long-term outcomes."
About the SYNERGY Bioabsorbable Polymer Stent
If
approved by the FDA, the SYNERGY Stent would become the first
bioabsorbable polymer stent available to patients in the U.S.
It features ultrathin stent struts with an abluminal bioabsorbable
drug/polymer coating technology that is absorbed shortly after drug
elution is complete at three months, thereby eliminating long-term
polymer exposure. Get more information on the SYNERGY
Clinical Program and Research in the U.S. Information is also
available for those outside the U.S.
The SYNERGY Stent is an investigational device in the U.S. and
Japan, and is not available for
sale in those countries. The SYNERGY Stent has CE mark
approval and is available for sale in countries where CE mark is
the regulation in force. View or download an image of the
SYNERGY Stent.
About Coronary Artery Disease
Coronary artery disease
is a narrowing of blood vessels that supply blood and oxygen to the
heart. Patients with coronary artery disease may experience
pain, shortness of breath and fatigue. They may also be at
risk for a heart attack. One treatment option is the
placement of a stent in the artery to help keep it open and allow
the blood to flow more freely.
Diabetes and Heart Disease
People who have diabetes
are twice as likely to have heart disease or a stroke, which
typically occurs at younger age than in those who do not have
diabetes. In addition, myocardial infarction in people with
diabetes is more likely to result in death. Furthermore,
persistent elevated blood glucose can result in an increase in
fatty deposits that may affect blood flow, thereby increasing the
risk of the development of atherosclerosis.[2]
About Boston Scientific
Boston Scientific transforms
lives through innovative medical solutions that improve the health
of patients around the world. As a global medical technology
leader for more than 35 years, we advance science for life by
providing a broad range of high performance solutions that address
unmet patient needs and reduce the cost of healthcare. For
more information, visit www.bostonscientific.com and connect on
Twitter and Facebook.
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CONTACTS
Media: Ryan Davenport
Global Media Relations
Boston Scientific Corporation
(763) 494-2664 (office)
media@bsci.com
Simonetta Balbi
PR and Corporate Communication Europe
Boston Scientific Corporation
+ 39 3387936422 (mobile)
+ 39 0106060281 (direct)
Balbis@bsci.com
Investors: Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
_________________________
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[1]
National Diabetes Information Clearinghouse (NDIC). A service of
the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK), National Institutes of Health (NIH);
http://diabetes.niddk.nih.gov/dm/pubs/stroke/#connection. Accessed
April 22, 2015.
|
[2]
National Diabetes Information Clearinghouse (NDIC). A service of
the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK), National Institutes of Health (NIH);
http://diabetes.niddk.nih.gov/dm/pubs/stroke/#connection. Accessed
April 22, 2015.
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SOURCE Boston Scientific