Sam Brusco, Associate Editor08.28.23
Boston Scientific released positive 12-month results from its pivotal, 607-patient ADVENT clinical trial of the FARAPULSE pulsed field ablation (PFA) system for paroxysmal AFib at this year’s European Society of Cardiology Congress.
FARAPULSE is a nonthermal treatment in which electric fields selectively ablate heart tissue in AFib patients. According to Boston Scientific, the study is the first randomized clinical trial to compare safety and efficacy of FARAPULSE against standard-of-care ablation—radiofrequency or cryoablation—to treat paroxysmal (intermittent) AFib.
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, meeting the primary efficacy endpoint. Procedure-related serious adverse events within seven days of the procedure were 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 also showed superiority of FARAPULSE in the study's secondary safety endpoint with “significantly less” post-ablation narrowing of the pulmonary veins at three months (0.9%) compared to thermal ablation (12%). There were “statistically shorter” ablation times and less variability with the FARAPULSE PFA System in the PFA arm (mean of 29.2 minutes with a standard deviation of 14.3 minutes) compared to the thermal arm (mean of 50 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," Vivek Reddy, MD, study principal investigator and electrophysiologist at Mount Sinai Hospital, told the press. "These highly anticipated findings, together with extensive prior data from Europe, solidify PFA therapy with this system as a preferred ablative treatment modality."
FARAPULSE earned CE mark approval in 2021, and Boston Scientific acquired the technology in 2021 as well.
"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."
FARAPULSE is a nonthermal treatment in which electric fields selectively ablate heart tissue in AFib patients. According to Boston Scientific, the study is the first randomized clinical trial to compare safety and efficacy of FARAPULSE against standard-of-care ablation—radiofrequency or cryoablation—to treat paroxysmal (intermittent) AFib.
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, meeting the primary efficacy endpoint. Procedure-related serious adverse events within seven days of the procedure were 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 also showed superiority of FARAPULSE in the study's secondary safety endpoint with “significantly less” post-ablation narrowing of the pulmonary veins at three months (0.9%) compared to thermal ablation (12%). There were “statistically shorter” ablation times and less variability with the FARAPULSE PFA System in the PFA arm (mean of 29.2 minutes with a standard deviation of 14.3 minutes) compared to the thermal arm (mean of 50 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," Vivek Reddy, MD, study principal investigator and electrophysiologist at Mount Sinai Hospital, told the press. "These highly anticipated findings, together with extensive prior data from Europe, solidify PFA therapy with this system as a preferred ablative treatment modality."
FARAPULSE earned CE mark approval in 2021, and Boston Scientific acquired the technology in 2021 as well.
"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."