MARLBOROUGH, Mass.,
May 22, 2019 /PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) has initiated the OPTION trial
to compare safety and effectiveness of the next-generation WATCHMAN
FLX™ left atrial appendage closure (LAAC) platform to
first-line oral anticoagulants (OAC) – including direct oral
anticoagulants (DOAC) and warfarin – for stroke risk reduction in
patients with non-valvular atrial fibrillation (AF) who undergo a
cardiac ablation procedure.
Approximately 33 million patients worldwide have AF, a common
heart rhythm disorder.1 In recent years, the number of
U.S. patients who have undergone an in-hospital cardiac ablation
procedure to prevent abnormal electrical signals from moving
through the heart has grown tenfold.2 More than 50% of
those patients become asymptomatic, making them less likely to
adhere to current guidelines recommending the continuation of OAC
post-procedure to reduce the risk of
stroke.3,4 Stroke is five times more likely to
occur in patients with AF than in someone with a normal heart
rhythm.5
"Cardiac ablation is an effective way to treat an abnormal heart
rhythm for many patients, though symptomatic relief can lead these
patients to stop taking their blood thinners and unknowingly put
themselves at an elevated risk for a stroke," said Dr. Oussama Wazni, co-director of the Ventricular
Arrhythmia Center, Center for Atrial Fibrillation and the Atrial
Fibrillation Stroke Prevention Center at Cleveland Clinic and the
principal investigator for the OPTION trial. "This
first-of-its-kind trial will explore whether the one-time WATCHMAN
FLX device could replace commonly used anticoagulants for long-term
stroke risk reduction in this growing patient population."
The randomized, controlled OPTION trial will enroll 1,600
patients with non-valvular AF who are suitable for OAC therapy and
have recently had or will have an ablation. Patients at as many as
130 global sites will be randomized to receive the
newest-generation WATCHMAN FLX device or an OAC, inclusive of
commonly prescribed DOACs or warfarin. The primary effectiveness
endpoint is all cause death, stroke and systemic embolism through
36 months, and the primary safety endpoint is non-procedural
bleeding through 36 months.
"Beyond advancing the robust clinical literature supporting the
WATCHMAN therapy, findings from the OPTION trial have the potential
to expand the number of patients with atrial fibrillation who can
receive an alternative to life-long anticoagulants and thus avoid
their potential side effects," said Dr. Ian Meredith, AM,
executive vice president and global chief medical officer, Boston
Scientific. "The unique study design encompasses patients who will
receive a WATCHMAN FLX device either after or concurrent to an
ablation procedure."
The WATCHMAN device has been implanted in more than 80,000
patients worldwide and the latest-generation WATCHMAN FLX device
received CE Mark in March 2019.
In the U.S., the WATCHMAN FLX device is an investigational
device and not available for sale.
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
Facebook.
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CONTACTS:
Angela Mineo
Media Relations
(763) 955-8325 (office)
Angela.Mineo@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
1 Chugh SS, et al. Worldwide epidemiology of atrial
fibrillation: a global burden of disease 2010 study. Circulation
2014;129:837–847. doi:
https://doi.org/10.1161/CIRCULATIONAHA.113.005119.
2 Hosseini, S, et al. Catheter ablation for cardiac
arrhythmias: utilization and in-hospital complications 2000-2013.
JACC: Clinical Electrophysiology. 2017. doi:
https://doi.org/10.1016/j.jacep.2017.05.005.
3 Arbelo E, et al. Contemporary management of patients
undergoing atrial fibrillation ablation: in-hospital and 1-year
follow-up findings from the ESC-EHRA atrial fibrillation ablation
long-term registry. European Heart Journal. 2017. doi:
https://doi.org/10.1093/eurheartj/ehw564.
4 Calkins, H, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert
consensus statement on catheter and surgical ablation of atrial
Fibrillation. Heart Rhythm Journal. 2017. doi:
https://doi.org/10.1016/j.hrthm.2017.07.009.
5 Atrial Fibrillation Fact Sheet." Centers for Disease Control
and Prevention.
http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm.
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SOURCE Boston Scientific Corporation