Boston Scientific is advancing its Farapulse pulse field ablation (PFA) system for atrial fibrillation (AFib) treatment, resuming a key trial and reporting positive data from another. The company's efforts aim to establish PFA as a safe and effective option for both first-line and drug-resistant AFib patients.
Avant Guard Trial Resumes
Boston Scientific has resumed enrollment in its Avant Guard trial, a prospective, randomized, multi-center, global study comparing PFA to anti-arrhythmic drug (AAD) therapy as a first-line treatment for persistent AFib. The trial had been paused to assess unanticipated observations, but resumed following review by the data monitoring committee. The Avant Guard trial utilizes the Farapulse PFA system, employing the Farawave PFA catheter to ablate heart tissue for pulmonary vein isolation and posterior wall isolation. For every three study participants, two will receive PFA first and the third will get AAD (including Flecainide, Sotalol, Propafenone, Dofetilide and Dronedarone). All study participants will have LUX-Dx insertable cardiac monitors (ICMs) implanted to monitor heart activity.
The trial aims to enroll a diverse patient population, with goals to include 12-15% persons of color and 43-45% women. According to Boston Scientific, this focus on diversity is crucial due to increased AFib risk factors and differences in management and treatment techniques among underrepresented ethnic and racial groups.
Advantage AF Trial Shows Promise
In addition to resuming the Avant Guard trial, Boston Scientific announced positive results from the Advantage AF trial, which evaluated the Farapulse system in patients with persistent AFib who did not respond well to drug therapy. The single-arm trial included 260 patients at 43 U.S. and global sites. The results, presented at the annual AF Symposium, demonstrated that the study met its primary safety endpoint with a 2.3% rate of major events, significantly below the 12% performance goal. Notably, there were no reports of stroke in the study.
The primary effectiveness rate was 63.5%, surpassing the study's acceptance criteria of 40%. Furthermore, over 85% of patients remained free from recurrent symptoms during the one-year follow-up period, with significant improvements in quality of life reported. According to Brad Sutton, Boston Scientific’s chief medical officer for atrial fibrillation solutions, the safety endpoints were largely unrelated to the ablation energy.
Path to Expanded Indication
Boston Scientific plans to use the Advantage AF data to support an FDA submission for an expanded indication for Farapulse in persistent AFib. The company anticipates receiving the label expansion by the end of this year. Currently, Farapulse is approved for treating paroxysmal (intermittent) AFib in patients who do not respond well to antiarrhythmic drugs. The persistent form of AFib represents approximately 25% of all AFib cases, marking a significant potential market for the expanded indication.
With Medtronic and Johnson & Johnson also launching competing PFA systems, the field is becoming increasingly competitive. However, Boston Scientific's Farapulse has gained rapid acceptance among physicians since its launch in January 2024, boosting the company's electrophysiology device sales.
