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.