First phase of ADVANTAGE AF clinical trial
achieves safety and effectiveness endpoints for treatment of
drug-resistant, symptomatic, persistent atrial fibrillation with
the FARAPULSE™ Pulsed Field Ablation System
Sub-analysis from OPTION clinical trial
highlights consistent safety and efficacy outcomes with the
WATCHMAN FLX™ Left Atrial Appendage Closure Device post cardiac
ablation in both concomitant and sequential procedures
MARLBOROUGH, Mass., Jan. 16,
2025 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) today announced data supporting the use of the
FARAPULSE™ Pulsed Field Ablation (PFA) System* and the
WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device,
respectively, during a late-breaking science session at AF
Symposium 2025.
ADVANTAGE AF clinical study
Currently, the FARAPULSE PFA System is approved for pulmonary
vein isolation (PVI) in patients who have paroxysmal AF, an
irregular heartbeat that occurs occasionally and typically
spontaneously resolves back to normal rhythm. The ADVANTAGE AF
study examined use of the FARAPULSE PFA System for both PVI and
posterior wall ablation (PWA) in patients who have persistent AF,
where individuals experience an irregular or rapid heartbeat that
lasts longer than seven days and which represent 25% of all AF
cases.1 The prospective, single arm trial included 260
patients enrolled at 43 global sites who were drug intolerant to at
least one Class I/III anti-arrhythmic drug (AAD).
Key findings from the study through 12 months included:
- The primary safety endpoint – defined as serious adverse events
related to either the use of an ablation catheter or the ablation
procedure within seven days of the primary procedure and pulmonary
vein stenosis or atrio-esophageal fistula out to 12 months – was
met with a 2.3% event rate.
- The primary effectiveness endpoint – defined as freedom from
AF, atrial flutter, atrial tachycardia, re-ablation, cardioversion
and use of a new or escalated dose of Class I/III AAD or amiodarone
– was met at 63.5%.
- The symptomatic AF recurrence-free rate was 85.3% and
observationally, among physicians that performed three or more
procedures, the symptomatic recurrence-free rate increased to
91.8%.
- There were no reported incidences of stroke, pulmonary vein
stenosis, atrio-esophageal fistula or major access
complications.
"In addition to the positive safety and efficacy outcomes
achieved in the ADVANTAGE AF study, a significant number of
patients were able to discontinue AADs as well as see greater
improvements in quality of daily life," said Vivek Reddy, M.D.**, director of
electrophysiology, Mount Sinai Fuster Heart Hospital, New York
and study principal investigator. "As the population of patients
living with AF continues to grow, data from trials such as
ADVANTAGE AF further support the paradigm shift to PFA as a
treatment for patients who are living with persistent and other
complex forms of AF."
OPTION trial sub-analysis
The late-breaking session also included a prespecified
sub-analysis from the OPTION clinical trial that built upon the
positive primary endpoint results presented at the American Heart
Association 2024 meeting and published in The New England
Journal of Medicine.2 In line with the overall
36-month outcomes from this first head-to-head study of the
WATCHMAN FLX device and direct oral anticoagulants (95% DOAC, 5%
warfarin), the sub-analysis of 1,600 patients with atrial
fibrillation who underwent a device implantation either
concomitantly or sequentially (90-180 days post ablation)
demonstrated:
- Consistent with the previously presented primary safety and
efficacy endpoint data presented in November
2024, concomitant LAAC with the WATCHMAN FLX device
following an ablation demonstrated a statistically significant 44%
reduction in non-procedural bleeding outcomes compared to OAC at 36
months (8.0% vs. 13.3%; p=0.02) and similar efficacy outcomes (7.0%
vs. 6.7% p=0.91), with the primary efficacy endpoint defined as
all-cause death, stroke or systemic embolism.
- Also consistent with the previously presented primary safety
and efficacy endpoint data, sequential LAAC with the WATCHMAN FLX
device following an ablation demonstrated a statistically
significant 62% reduction in non-procedural bleeding outcomes
compared to OAC at 36 months (8.8% vs. 21.5%; p<0.0001) and
similar efficacy outcomes (4.2% vs. 5.3%; p=0.45).
- Similar stroke protection with the WATCHMAN FLX device compared
to OAC irrespective of concomitant (2.3% vs. 2.5% rates of all
stroke) or sequential (1.1% vs 1.6%) implantation.
"These late-breaking studies provide valuable clinical evidence
supporting our ablation and stroke prevention technologies that are
designed to improve long-term outcomes for patients with atrial
fibrillation," said Dr. Brad Sutton,
M.D., chief medical officer, Atrial Fibrillation Solutions, Boston
Scientific. "The positive findings support our focus on expanding
the number of patients who can benefit from these life-changing
therapies, which we will continue to advance through future
clinical trials and product development."
More information on the ADVANTAGE AF study is available here and
on the OPTION trial here.***
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
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the meaning of Section 27A of the Securities Act of 1933 and
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CONTACTS:
Becca Johnson
Media Relations
+1 (952) 994-8526
Rebecca.Johnson@bsci.com
Jon Monson
Investor Relations
+1 (508) 683-5450
BSXInvestorRelations@bsci.com
*CAUTION: Investigational Device. Limited by Federal (or US) law
to investigational use only. Ablation beyond pulmonary vein
isolation is outside the use of labeled indication of the FARAWAVE
PFA Catheter with the FARAPULSE PFA System.
**Dr. Vivek Reddy is a paid consultant of Boston
Scientific Corporation. He has not been compensated in connection
with this press release.
*** The FARAPULSE PFA System was not commercially
available at the time of the OPTION trial initiation and was not
included in the trial design.
1Zoni-Berisso M, Lercari F, Carazza T,
Domenicucci S. Epidemiology of atrial fibrillation: European
perspective. Clin Epidemiol. 2014;6:213-220. doi:
10.2147/CLEP.S47385
2 Wazni OM, Saliba WI, Nair DG, et al. Left
atrial appendage closure after ablation for atrial fibrillation.
N Engl J Med. 2024 Nov 16. doi:10.1056/NEJMoa2408308
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