Noninferiority established through high
treatment success, low adverse event rates
Findings presented at ESC Congress 2023 and
simultaneously published in The New England Journal of
Medicine
MARLBOROUGH, Mass. and AMSTERDAM, Aug. 27,
2023 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) today announced positive 12-month results from the
pivotal ADVENT clinical trial of the FARAPULSE™ Pulsed Field
Ablation (PFA) System*, a nonthermal treatment in which electric
fields selectively ablate heart tissue in patients with atrial
fibrillation (AF). The study is the first randomized clinical trial
to directly compare the efficacy and safety of the FARAPULSE PFA
System against standard-of-care ablation – either radiofrequency or
cryoablation – for the treatment of patients with paroxysmal, or
intermittent, AF. Findings were presented at ESC Congress 2023, the
annual meeting of the European Society of Cardiology, and
simultaneously published in The New England Journal of
Medicine.
Data demonstrated the FARAPULSE PFA System was noninferior to
standard-of-care therapies, meeting the primary efficacy and safety
endpoints, despite the vast majority of physicians having prior
experience solely with thermal ablation.** Of note:
- Through 12 months, the single-procedure, off-drug treatment
success was 73.3% in the PFA arm of the study and 71.3% in the
thermal arm, which met the primary efficacy endpoint.
- The primary composite safety endpoint – defined as acute and
chronic device- and procedure-related serious adverse events within
seven days of the procedure – was met with a comparably low adverse
event rate of 2.1% (six events) in the PFA arm and 1.5% (four
events) in the thermal arm.
- Results demonstrated superiority of the FARAPULSE PFA System in
the study's secondary safety endpoint with significantly less
post-ablation narrowing of the pulmonary veins at three months
(0.9%) compared to the thermal ablation arm (12%).
- There were statistically shorter ablation times and less
variability with the FARAPULSE PFA System within the PFA arm of the
study (mean of 29.2 minutes with a standard deviation of 14.3
minutes) compared to the thermal arm (mean of 50.0 minutes with a
standard deviation of 24.6 minutes).
"Excellent overall clinical performance of the FARAPULSE PFA
System was seen in this study, particularly the high rate of
freedom from atrial arrhythmias and the very low rate of safety
events, which is impressive given the rigor of the trial design and
monitoring protocols utilized," said Vivek
Reddy, M.D., study principal investigator and
electrophysiologist at Mount Sinai Hospital, New York. "These highly anticipated findings,
together with extensive prior data from Europe, solidify PFA therapy with this system
as a preferred ablative treatment modality."
In this multicenter, prospective and randomized controlled
trial, 607 patients in the U.S. with paroxysmal AF who had
previously been unsuccessfully treated with at least one
anti-arrhythmic drug were enrolled.
"These data underscore the superior procedural efficiency of
this novel technology, and real-world use continues to yield strong
safety and efficacy outcomes," said Kenneth
Stein, M.D., senior vice president and global chief medical
officer, Boston Scientific. "The performance of the FARAPULSE PFA
System in this trial is an encouraging sign of the potential
utilization of the device in the U.S. and we look forward to
further studying the system for the treatment of patients with
persistent AF in the ADVANTAGE AF clinical trial, which began
enrollment earlier this year."
The FARAPULSE PFA System received CE Mark in 2021 and has been
used to treat more than 25,000 patients globally to date.
More information on the ADVENT clinical trial is available
here.
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 and Facebook.
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the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements may be identified by words like
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CONTACTS:
Steve Bailey
Media Relations
(651) 582-4343 (office)
Steve.Bailey@bsci.com
Lauren Tengler
Investor Relations
(508) 683-4479
BSXInvestorRelations@bsci.com
*Caution: Investigational Device. Limited by Federal (or US)
law to investigational use only. Not available for sale.
**ADVENT trial endpoints were analyzed using Bayesian
statistical methods.
***Dr. Vivek Reddy 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