Data also demonstrates that the stroke risk
reduction device is as effective as oral anticoagulants for
patients with atrial fibrillation following a cardiac
ablation
MARLBOROUGH, Mass. and CHICAGO, Nov. 16,
2024 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) today announced positive three-year primary endpoint
results from the OPTION global clinical trial of the WATCHMAN FLX™
Left Atrial Appendage Closure (LAAC) Device. Key findings from the
study comparing the device to first-line oral anticoagulation (OAC)
– including direct oral anticoagulants (DOAC) (95%) and warfarin
(5%) – for stroke risk reduction in patients with non-valvular
atrial fibrillation following a cardiac ablation were presented in
a late-breaking science session at the American Heart Association's
Scientific Sessions 2024, and simultaneously published in The
New England Journal of Medicine.
The trial met the primary safety endpoint of non-procedural
major bleeding or clinically relevant non-major bleeding at 36
months, with the WATCHMAN FLX device demonstrating superiority to
OAC (8.5% vs.18.1%; P<0.0001). It also met the primary efficacy
endpoint of all-cause death, stroke or systemic embolism at 36
months, with the data showing non-inferiority of the device to OAC
(5.4% vs. 5.8%; P<0.0001). Additional findings included
non-inferiority of the WATCHMAN FLX device for the combined
secondary endpoint of procedural and non-procedural major bleeding
at 36 months (3.9% vs. 5.0%; P<0.0001).
In recent years, the number of patients with atrial fibrillation
who have undergone a cardiac ablation procedure to prevent symptoms
has grown significantly. Due to the risk of atrial fibrillation
recurrence following an ablation, current treatment guidelines
recommend that patients with multiple stroke risk factors remain on
OAC long term to reduce the risk of stroke. However, symptomatic
relief can lead these patients to stop taking their blood thinners,
increasing this risk, while long-term use of OAC also presents a
risk of serious bleeding.
"The OPTION trial data provide clinical evidence indicating
that, among patients who have undergone an ablation, LAAC with the
WATCHMAN FLX device is not only as safe, but superior to OAC
therapy for reducing the risk of long-term bleeding events," said
Dr. Oussama Wazni, vice chairman of
Cardiovascular Medicine and section head, Cardiac
Electrophysiology, Cleveland Clinic, and principal investigator of
the OPTION trial.* "Notably, we found high rates of procedural
success in patients who had a WATCHMAN FLX implant after an
ablation, and of patient adherence to their prescribed medication
regimen following the procedures, which likely reinforced positive
outcomes such as the low rates of ischemic and hemorrhagic stroke
within the trial population."
The randomized, controlled OPTION trial included 1,600 patients
enrolled across 114 sites in the United
States, Europe and
Australia, and demonstrated high
rates of procedural success. In the trial, approximately 60% of
device patients had their WATCHMAN FLX implant 90-180 days
following their ablation procedure. The other nearly 40% of the
device patients had the two procedures performed concomitantly,
with the WATCHMAN FLX implant taking place after the ablation.
"The OPTION trial is the first large, randomized trial to
rigorously evaluate LAAC as a safe and effective stroke risk
reduction treatment following a cardiac ablation in a head-to-head
fashion against commonly used oral anticoagulants, including DOAC,"
said Brad Sutton, M.D., chief
medical officer, Atrial Fibrillation Solutions, Boston Scientific.
"These positive primary outcomes mean that patients receiving the
WATCHMAN FLX device were able to eliminate long-term medication use
while maintaining stroke protection. With this data, we see
potential to both expand the indication for the WATCHMAN FLX
platform and ultimately elevate it to become a frontline therapy
for patients receiving cardiac ablation for atrial fibrillation to
reduce their risk of stroke."
In addition to the OPTION trial, the WATCHMAN technology is
being evaluated against DOAC as a first-line therapy in lower-risk
patients within the CHAMPION-AF randomized trial. The
latest-generation WATCHMAN FLX™ Pro LAAC Device, which was approved
in the United States in 2023, is
similarly being studied in several clinical trials, including the
SIMPLAAFY randomized controlled trial that is evaluating a
single-drug alternative to dual anti-platelet therapy as a
post-procedural regimen.
For more information on the OPTION trial, visit
https://www.watchman.com/en-us-implanter/clinical-evidence/option.html.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
technologies that improve the health of patients around the world.
As a global medical technology leader for more than 45 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 health care. Our portfolio of devices and
therapies helps physicians diagnose and treat complex
cardiovascular, respiratory, digestive, oncological, neurological
and urological diseases and conditions. Learn more at
www.bostonscientific.com and connect on
LinkedIn and X, formerly Twitter.
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CONTACTS:
Angela Mineo
Media Relations
+1 (763) 955-8325
Angela.Mineo@bsci.com
Jon Monson
Investor Relations
+1 (508) 683-5450
BSXInvestorRelations@bsci.com
*Dr. Oussama Wazni is a paid
consultant of Boston Scientific Corporation. He has not been
compensated in connection with this press release.
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SOURCE Boston Scientific Corporation