Data from first coronary DCB study in U.S.
meet 12-month primary endpoint, demonstrate low adverse event rates
with AGENT DCB
MARLBOROUGH, Mass. and SAN FRANCISCO, Oct. 25,
2023 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) today announced positive 12-month results from the
pivotal AGENT IDE clinical trial of the AGENT™ Drug-Coated Balloon
(DCB).1 Primary endpoint findings from this first
clinical trial in the U.S. to evaluate the safety and effectiveness
of using a DCB to treat coronary in-stent restenosis (ISR) were
presented in a late-breaking clinical trial session at
Transcatheter Cardiovascular Therapeutics (TCT), the annual
scientific symposium of the Cardiovascular Research Foundation.
While coronary stenting is commonly used to restore blood flow
to the heart in patients with coronary artery disease, ISR – a
condition in which the stented section of the artery becomes
obstructed or narrowed by plaque or scar tissue – still occurs in
some cases and is addressed in 10% of U.S. percutaneous coronary
interventions.2,3 The AGENT DCB is a
paclitaxel-coated balloon catheter designed to re-open these
vessels and then transfer the therapeutic drug to the vessel wall
to help prevent ISR reoccurrence.
This trial met the primary endpoint of target lesion
failure4 (TLF) at 12 months with the AGENT DCB
demonstrating statistical superiority to uncoated balloon
angioplasty (17.9% vs. 28.7%; P=0.006). These differences were
mainly driven by significantly reduced rates of myocardial
infarction related to the target vessel (TV-MI, or heart attack)
and the need for a target lesion revascularization (TLR, or a
repeated percutaneous coronary intervention) procedure. Overall,
data demonstrated an approximate 38% relative risk reduction in
TLF, and additional 12-month event rates for the AGENT DCB vs.
uncoated balloon included:
- Zero definite/probable cases of clotting within the stent,
known as stent thrombosis (0.0% vs. 3.9%, P=0.001)
- 51% risk reduction in TLR (12.4% vs. 24.0%, P=0.002)
- 49% risk reduction in TV-MI (6.4% vs. 12.3%, P=0.03)
"Positive outcomes in this complex trial population – from the
markedly lower rate of target lesion failure to the significant
reduction in heart attack and no stent thromboses – support the
AGENT DCB as an alternative treatment option for coronary in-stent
restenosis," said principal investigator Dr. Robert W. Yeh, section chief of interventional
cardiology at the Beth Israel Deaconess Medical Center, and the
Katz-Silver Family Professor of Medicine at Harvard Medical School. "Meaningful therapy
advancements for this condition are critical, and the ability to
reduce the risk of restenosis without using radiation or
introducing another layer of metal stenting is a promising step
forward."
The data presented today from this multicenter, prospective and
randomized controlled AGENT IDE trial include the first 480 of 600
patients enrolled across 40 U.S. sites.5 Within the
patient population, 44% had multiple stent layers in the target
lesion, and 51% were diabetic.
"These encouraging results add to the growing body of clinical
evidence supporting the AGENT DCB, spanning nearly 7,400 patients
in 14 completed and ongoing studies worldwide," said Dr.
Janarthanan Sathananthan, M.D.,
chief medical officer, Interventional Cardiology Therapies, Boston
Scientific. "In light of the successful real-world use of the
device outside the U.S., we look forward to using these encouraging
data to support FDA approval and bringing this important therapy to
more physicians and patients in need."
The AGENT DCB was approved in Japan in 2023 and received CE Mark in 2014 for
the treatment of patients with ISR and previously untreated small
vessel coronary disease. Used to treat more than 100,000 patients
globally to date, this technology was granted Breakthrough Device
designation by the U.S. Food and Drug Administration in 2021, a
status intended to provide patients more timely access to novel
devices that may provide a substantial improvement over existing
therapies. More information on the AGENT IDE trial is available
here.
The AGENT DCB is an investigational device. Restricted by
Federal law to investigational use only. Not available for sale in
the U.S.
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 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
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CONTACTS:
Angela Mineo
Media Relations
(763) 955-8325 (office)
Angela.mineo@bsci.com
Lauren Tengler
Investor Relations
(508) 683-4479
BSXInvestorRelations@bsci.com
* Dr. Robert Yeh is a paid
consultant of Boston Scientific Corporation. He has not been
compensated in connection with this press release.
1 Yeh RW, Bachinsky W, Stoler R, et al. Rationale and
design of a randomized study comparing the AGENT drug coated
balloon to plain old balloon angioplasty in patients with In-stent
restenosis. American Heart Journal. 2021;241:101-107.
doi:10.1016/j.ahj.2021.07.008.
2 Moussa ID, Mohananey D, Saucedo J, et al. Trends and
outcomes of restenosis after coronary stent implantation in
the United States. J Am Coll
Cardiol. 2020;76:1521-1531.
3 Shlofmitz E, Iantorno M, Waksman R. Restenosis of
Drug-Eluting Stents: A New Classification System Based on Disease
Mechanism to Guide Treatment and State-of-the-Art Review. Circ
Cardiovasc Interv. 2019 Aug;12(8):e007023. doi:
10.1161/CIRCINTERVENTIONS.118.007023.
4 TLF was defined as myocardial infarction relative
to the target vessel, the need for a target lesion
revascularization (TLR) procedure or cardiac mortality.
5 Prespecified interim analysis of 480 patients
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SOURCE Boston Scientific Corporation