WASHINGTON and MARLBOROUGH, Mass., Nov. 1, 2016 /PRNewswire/ -- As part of the
commitment to support health equity for all patients, Boston
Scientific Corporation (NYSE: BSX) sponsored the PLATINUM Diversity
study to evaluate the clinical outcomes of the Promus
PREMIER™ Everolimus-Eluting Platinum Chromium Coronary
Stent System in women and minorities. The clinical endpoints were
presented today at the 28th Transcatheter Cardiovascular
Therapeutics (TCT), the annual scientific symposium of the
Cardiovascular Research Foundation.
In this study, there were no significant outcome differences
between white men and women or minorities for the composite primary
endpoint of death, myocardial infarction (MI) or target vessel
revascularization (TVR) at 12 months. The composite death/MI/TVR
rate was 7.6 percent for white men compared to 8.6 percent for
women (p=0.33), and 9.6 percent for minorities (p=0.08).
Additionally, secondary endpoint results were as follows
(differences with p<0.05 were statistically significant):
- All-cause death: 2.2 percent for white men compared to 3.4
percent for women (p=0.04), and 3.7 percent for minorities
(p=0.03).
- MI: 1.1 percent for white men compared to 1.9 percent for women
(p=0.06), and 3.1 percent for minorities (p=0.0002).
- TVR: 5.5 percent for white men compared to 4.6 percent for
women (p=0.27), and 5.4 percent for minorities (p=0.97)
- Definite or probable stent thrombosis: 0.7 percent for white
men compared to 0.9 percent for women (p=0.55), and 1.2 percent for
minorities (p=0.22).
"Most clinical trials examine how any given treatment impacts
patient outcomes; however, given that much of an individual's
health is determined by non-clinical factors, we thought it
important to design the PLATINUM Diversity study in order to better
understand the nature and magnitude of outcome disparities that
exist for under-represented groups after contemporary coronary
stent procedures," said Wayne
Batchelor, M.D., co-principal investigator and chair of the
Interventional Cardiology Council at Tallahassee Memorial Hospital,
Tallahassee, Florida.
"The initial evaluation of the primary endpoint is the first of
many analyses that we believe will provide invaluable insights into
the social, behavioral and economic determinants of health in women
and minorities who undergo coronary stent procedures," said
Roxana Mehran, M.D., co-principal
investigator and director of the Office of Interventional
Cardiovascular Research and Clinical Trials of Mount Sinai Heart
and professor of Cardiology and Population Health Science and
Policy at Icahn School of Medicine at Mount Sinai in New
York City.
Heart disease takes a greater toll on certain racial and ethnic
groups yet historically, large-scale clinical trials in cardiology
have had a disproportionately low inclusion of women and
minorities. As a result, physicians have had little data on which
to base their clinical decisions when treating these patients. The
PLATINUM Diversity study was initiated in October 2014 to provide important insights that
can ultimately help physicians customize treatment plans for
patient-specific demographics and socioeconomic status.
"The PLATINUM Diversity study is tangible evidence of the
commitment by Boston Scientific to raise awareness of the needs of
underserved patient communities across the country, and is a
critical first step in advancing care for all patients," says
Paul Underwood, M.D., medical
director of clinical interventional cardiology at Boston
Scientific. "Our hope is that these 'real-world' results from the
PLATINUM Diversity study will help clinicians, researchers
and advocates understand the existing challenges so that we can
work collaboratively to close the gender, race and ethnicity gap
when treating cardiovascular disease."
The PLATINUM Diversity study is an observational, prospective,
multicenter, open-label, single-arm, post-approval study that
enrolled 1,501 patients at 52 sites in the U.S. from understudied
populations, specifically women, African Americans,
Latinos/Hispanics, American Indians or Alaska Natives. All patients
in this single arm study received at least one Promus PREMIER
drug-eluting stent. Patient data from the PROMUS Element™ Plus
Stent System post-approval study will be included in the full
analysis to allow for comparisons to white men, increasing the
total number of patients to 4,188. The Promus PREMIER stent system
received CE Mark approval in February
2013 and has been available in the U.S. since November 2013. The PROMUS Element Plus stent
system received CE Mark approval in 2009 and FDA approval in
2011.
About Coronary Artery Disease
Coronary artery disease
(CAD) – the most common type of heart disease – is a narrowing of
blood vessels that supply blood and oxygen to the heart. An
estimated 15 million Americans have CAD.1 These patients
may experience pain, shortness of breath, fatigue and may 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 to the heart.
According to the U.S. Centers for Disease Control and
Prevention, cardiovascular disease is the leading cause of death
for all Americans, including women and
minorities.2 Despite this reality, women
represent less than one-third of those enrolled in cardiovascular
trials conducted since 2006.3 Black Americans
represent about 12 percent of the U.S. population, have the highest
heart disease death rate, and yet they comprise just five percent
of patients in cardiovascular clinical trials.4,5
Hispanics, now the largest racial/ethnic group in America,
representing nearly 16 percent of the U.S. population, have the
highest risk factor profile, but account for a mere one percent of
study patients.6,7
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.
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 the Securities Exchange Act of 1934. Forward-looking
statements may be identified by words like "anticipate," "expect,"
"project," "believe," "plan," "estimate," "intend" and similar
words. These forward-looking statements are based on our beliefs,
assumptions and estimates using information available to us at the
time and are not intended to be guarantees of future events or
performance. These forward-looking statements include, among other
things, statements regarding our business plans, regulatory
approvals and product performance and impact. If our
underlying assumptions turn out to be incorrect, or if certain
risks or uncertainties materialize, actual results could vary
materially from the expectations and projections expressed or
implied by our forward-looking statements. These factors, in some
cases, have affected and in the future (together with other
factors) could affect our ability to implement our business
strategy and may cause actual results to differ materially from
those contemplated by the statements expressed in this press
release. As a result, readers are cautioned not to place undue
reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other
things: future economic, competitive, reimbursement and regulatory
conditions; new product introductions; demographic trends;
intellectual property; litigation; financial market conditions; and
future business decisions made by us and our competitors. All of
these factors are difficult or impossible to predict accurately and
many of them are beyond our control. For a further list and
description of these and other important risks and uncertainties
that may affect our future operations, see Part I, Item 1A – Risk
Factors in our most recent Annual Report on Form 10-K filed with
the Securities and Exchange Commission, which we may update in Part
II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we
have filed or will file hereafter. We disclaim any intention or
obligation to publicly update or revise any forward-looking
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conditions or circumstances on which those expectations may be
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CONTACTS:
Timette Nevala
Media Relations
Boston Scientific Corporation
763-494-1284 (office)
Timette.Nevala@bsci.com
Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
_______________________________
1 Understanding coronary artery disease. CardioSmart
website.
https://www.cardiosmart.org/News-and-Events/2016/06/Understanding-CAD.
Published June 2016. Accessed
October 21, 2016.
2 Kochanek KD, Murphy SL, Xu J, Tejada-Vera B. Deaths: final data for 2014.
Natl Vital Stat Rep. 2016;65(4):1-122.
http://www.cdc.gov/nchs/data/nvsr/nvsr65/nvsr65_04.pdf. Published
June 30, 2016. Accessed October 21, 2016.
3 Maas AH, van der Schouw YT, Regitz-Zagrosek
V, et al. Red alert for women's heart: the urgent need for
more research and knowledge on cardiovascular disease in women.
Proceedings of the Gender Differences in Cardiovascular
Disease workshop; September 29,
2010; Brussels,
Belgium. Eur Heart J. 2011;32(11):1362-1368.
http://eurheartj.oxfordjournals.org/content/32/11/1362.long.
4 The Society for Women's Health Research and United
States Food and Drug Administration Office of Women's Health.
Successful Strategies for Engaging Women and Minorities in
Clinical Trials. Final report of the Dialogues on Diversifying
Clinical Trials; September 22-23,
2011; Washington, DC.
http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM334959.pdf.
Accessed October 21, 2016.
5 Sidney S, Quesenberry CP Jr, Jaffe MG, et al.
Recent trends in cardiovascular mortality in the United States and public health goals.
JAMA Cardiol. 2016;1(5):594-599.
http://jamanetwork.com/journals/jamacardiology/fullarticle/2530559.
6 Coakley M, Fadiran EO, Parrish LJ, Griffith RA,
Weiss E, Carter C. Dialogues on diversifying clinical trials:
successful strategies for engaging women and minorities in clinical
trials. J Womens Health (Larchmt). 2012;21(7):713-716.
http://online.liebertpub.com/doi/abs/10.1089/jwh.2012.3733.
7 Mozaffarian D, Benjamin EJ, Go AS, et al.; American
Heart Association Statistics Committee and Stroke Statistics
Subcommittee. Heart disease and stroke statistics-2016 update: a
report from the American Heart Association. Circulation.
2016;133(4):e38-360.
http://circ.ahajournals.org/cgi/pmidlookup?view=long&pmid=26673558.
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SOURCE Boston Scientific Corporation