Boston Scientific announces AVENT study met primary, safety endpoints

Boston Scientific announced 12-month results from the pivotal ADVENT clinical trial of the Farapulse Pulsed Field Ablation, or PFA, System, a nonthermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation, or 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. 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% in the PFA arm and 1.5% 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 compared to the thermal ablation arm. There were statistically shorter ablation times and less variability with the Farapulse PFA System within the PFA arm of the study compared to the thermal arm. 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.