Boston Scientific announced data supporting the use of the Farapulse pulsed field ablation (PFA) system and the Watchman FLX left atrial appendage closure (LAAC) device, respectively, during a late-breaking science session at the 30th annual AF symposium (16–18 January 2025, Boston, USA).
While the Farapulse PFA system is currently approved for pulmonary vein isolation (PVI) in patients who have paroxysmal atrial fibrillation (AF), Boston Scientific’s ADVANTAGE AF study examined use of the system for both PVI and posterior wall ablation (PWA) in patients who have persistent AF. The prospective, single-arm trial included 260 patients enrolled at 43 global sites who were intolerant to at least one Class I/III anti-arrhythmic drug (AAD).
Key findings from the study through 12 months included:
- The primary safety endpoint—defined as serious adverse events related to either the use of an ablation catheter or the ablation procedure within seven days of the primary procedure, and pulmonary vein stenosis or atrio-oesophageal fistula out to 12 months—being met with a 2.3% event rate
- The primary effectiveness endpoint—defined as freedom from AF, atrial flutter, atrial tachycardia, re-ablation, cardioversion, and use of a new or escalated dose of Class I/III AAD or amiodarone—being met at a rate of 63.5%
- A symptomatic AF recurrence-free rate of 85.3% that, observationally, among physicians that performed three or more procedures, increased to 91.8%
- No reported incidences of stroke, pulmonary vein stenosis, atrio-oesophageal fistula or major access complications
“In addition to the positive safety and efficacy outcomes achieved in the ADVANTAGE AF study, a significant number of patients were able to discontinue AADs as well as see greater improvements in quality of daily life,” said Vivek Reddy (Mount Sinai Fuster Heart Hospital, New York, USA), study principal investigator. “As the population of patients living with AF continues to grow, data from trials such as ADVANTAGE AF further support the paradigm shift to PFA as a treatment for patients who are living with persistent and other complex forms of AF.”
The late-breaking session at the AF symposium also included a prespecified sub-analysis from the OPTION clinical trial, building upon the positive primary endpoint results presented at last year’s American Heart Association (AHA) Scientific Sessions (16–18 November 2024, Chicago, USA) and published in the New England Journal of Medicine.
In line with the overall 36-month outcomes from this first head-to-head study of the Watchman FLX device and direct oral anticoagulants (DOACs), the sub-analysis of 1,600 patients with AF who underwent a device implantation either concomitantly or sequentially (90–180 days post-ablation) found that:
- Consistent with the previously presented primary safety and efficacy endpoint data, concomitant LAAC with the Watchman FLX device following an ablation demonstrated a statistically significant 44% reduction in non-procedural bleeding outcomes compared to OAC at 36 months (8% vs 13.3%, p=0.02) and similar efficacy outcomes (7% vs 6.7%, p=0.91), with the primary efficacy endpoint defined as all-cause death, stroke or systemic embolism
- Also consistent with the previously presented data, sequential LAAC with the Watchman FLX device following an ablation demonstrated a statistically significant 62% reduction in non-procedural bleeding outcomes compared to OAC at 36 months (8.8% vs 21.5%, p<0.0001) and similar efficacy outcomes (4.2% vs 5.3%, p=0.45)
- There were similar outcomes in terms of stroke protection with the Watchman FLX device compared to OAC, irrespective of concomitant (2.3% vs 2.5% rates of all strokes) or sequential (1.1% vs 1.6%) implantation
“These late-breaking studies provide valuable clinical evidence supporting our ablation and stroke prevention technologies that are designed to improve long-term outcomes for patients with atrial fibrillation,” said Brad Sutton, chief medical officer, Atrial Fibrillation Solutions, Boston Scientific. “The positive findings support our focus on expanding the number of patients who can benefit from these life-changing therapies, which we will continue to advance through future clinical trials and product development.”
