SAN FRANCISCO and MARLBOROUGH, Mass., Sept. 26, 2019
/PRNewswire/ -- Boston Scientific (NYSE: BSX) has announced
primary endpoint results from the EVOLVE Short DAPT clinical trial,
the first prospective study initiated in the U.S. to examine the
safety of a shortened duration of dual antiplatelet therapy (DAPT)
in patients at high risk for bleeding. Results were presented
during a late-breaking clinical science session at the 31st
Transcatheter Cardiovascular Therapeutics (TCT), the annual
scientific symposium of the Cardiovascular Research Foundation, in
San Francisco, and
demonstrated that a three-month regimen of DAPT is
non-inferior to a 12-month or longer regimen in patients with an
increased risk of bleeding after being treated with the SYNERGY™
Bioabsorbable Polymer (BP) Stent.
Patients within the trial were implanted with at least one
SYNERGY BP stent and considered at high risk for bleeding after
meeting at least one of the criteria such as: age of 75 or older
with the risk of longer term DAPT deemed greater than the benefit,
a history of stroke, renal insufficiency or failure, the need for
chronic anticoagulation therapy or history of major bleeding in the
prior 12 months. The co-primary endpoints of the study assessed the
rate of death or myocardial infarction (MI) and the rate of stent
thrombosis between three and 15 months. Both primary endpoints were
successfully met.
"These data prospectively demonstrate a low rate of adverse
events for patients who are at high risk for bleeding and who then
stop DAPT at three months," said Ajay
Kirtane, M.D., director of Cardiac Catheterization
Laboratories at Columbia University
Irving Medical Center/New York-Presbyterian Hospital and principal
investigator of the EVOLVE Short DAPT trial. "This is critically
important information because previously, the required duration of
DAPT following implantation of current generation drug-eluting
stent platforms was unknown. These data better inform physicians as
to how best to tailor the recommended duration of DAPT to the
bleeding risk of the patients they treat."
The global EVOLVE Short DAPT trial enrolled 2,009 patients and
of those, 1,487 patients were eligible to discontinue
dual-antiplatelet therapy at three months. In patients treated with
a short DAPT regimen, investigators found that the rate of death or
MI between three and 15 months was non-inferior in the three-month
DAPT group compared to a historical control group of patients
treated with 12-month DAPT (5.6% vs. 5.7%, p-value for
non-inferiority was 0.002). Additionally, the rate of stent
thrombosis between three and 15 months in the patients treated with
three-month DAPT was 0.3%, significantly lower than the endpoint
performance goal of 1.0%.
"We are pleased the study presented today provided robust safety
data on shortened DAPT following implantation of the SYNERGY BP
Stent for this patient population, as the reduced length of therapy
can be a clinically significant differentiator," said Ian Meredith, M.D., executive vice president and
global chief medical officer, Boston Scientific. "We continue to
build upon the body of evidence supporting the excellent clinical
outcomes of the SYNERGY BP Stent and look forward to submitting
these data to regulatory authorities to support an indication for
use of this stent in patients at high risk of experiencing a
bleeding event."
This month, the company received CE Mark for the SYNERGY
MEGATRON™ Bioabsorbable Polymer (BP) Stent, the newest stent within
the SYNERGY family of products. The SYNERGY MEGATRON BP stent is
designed for use in large proximal vessels and features
architecture with increased strength as well as the ability to
expand to 6.0mm in diameter and accommodate tapered vessels.
Please see the SYNERGY BP Stent Directions for Use for full
antiplatelet prescribing information.
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 40 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
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Media Relations
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SOURCE Boston Scientific Corporation