Late-breaking data presented at AF Symposium 2025 highlight key Boston Scientific therapies for management of patients with atrial fibrillation
Boston Scientific (BSX) announced positive clinical data for two key atrial fibrillation therapies at AF Symposium 2025. The ADVANTAGE AF trial for the FARAPULSE™ PFA System met its primary endpoints, showing a 2.3% safety event rate and 63.5% effectiveness rate in treating persistent AF patients, with an 85.3% symptomatic AF recurrence-free rate.
A sub-analysis of the OPTION trial demonstrated that the WATCHMAN FLX™ device significantly reduced bleeding outcomes compared to oral anticoagulants. Concomitant procedures showed a 44% reduction (8.0% vs. 13.3%) while sequential procedures demonstrated a 62% reduction (8.8% vs. 21.5%) in non-procedural bleeding at 36 months. Both approaches maintained similar efficacy outcomes and stroke protection compared to oral anticoagulants.
Boston Scientific (BSX) ha annunciato dati clinici positivi per due importanti terapie per la fibrillazione atriale durante l'AF Symposium 2025. Lo studio ADVANTAGE AF per il sistema FARAPULSE™ PFA ha raggiunto i suoi obiettivi primari, mostrando un tasso di eventi avversi del 2,3% e un tasso di efficacia del 63,5% nel trattamento dei pazienti con AF persistente, con una percentuale del 85,3% di pazienti senza recidiva di AF sintomatica.
Un'analisi secondaria dello studio OPTION ha dimostrato che il dispositivo WATCHMAN FLX™ ha significativamente ridotto gli esiti emorragici rispetto agli anticoagulanti orali. Le procedure concomitanti hanno mostrato una riduzione del 44% (8,0% vs. 13,3%), mentre le procedure sequenziali hanno dimostrato una riduzione del 62% (8,8% vs. 21,5%) delle emorragie non procedure al termine di 36 mesi. Entrambi gli approcci hanno mantenuto risultati di efficacia simili e protezione contro l'ictus rispetto agli anticoagulanti orali.
Boston Scientific (BSX) anunció datos clínicos positivos para dos terapias clave de fibrilación auricular durante el AF Symposium 2025. El ensayo ADVANTAGE AF para el sistema FARAPULSE™ PFA cumplió con sus objetivos primarios, mostrando una tasa de eventos adversos del 2,3% y una tasa de efectividad del 63,5% en el tratamiento de pacientes con FA persistente, con una tasa libre de recurrencias sintomáticas de FA del 85,3%.
Un subanálisis del ensayo OPTION demostró que el dispositivo WATCHMAN FLX™ redujo significativamente los resultados hemorrágicos en comparación con los anticoagulantes orales. Los procedimientos concomitantes mostraron una reducción del 44% (8,0% frente a 13,3%), mientras que los procedimientos secuenciales demostraron una reducción del 62% (8,8% frente a 21,5%) en las hemorragias no procedimentales a los 36 meses. Ambos enfoques mantuvieron resultados de eficacia similares y protección contra accidentes cerebrovasculares en comparación con los anticoagulantes orales.
Boston Scientific (BSX)는 AF Symposium 2025에서 두 가지 주요 심방 세동 치료법에 대한 긍정적인 임상 데이터를 발표했습니다. FARAPULSE™ PFA 시스템을 위한 ADVANTAGE AF 시험이 주요 목표를 달성하여 지속적인 AF 환자 치료에서 2.3%의 안전성 사건 비율과 63.5%의 효과성 비율을 보였으며, 85.3%의 증상성 AF 재발 없는 비율을 기록했습니다.
OPTION 시험의 하위 분석 결과 WATCHMAN FLX™ 장치가 경구 항응고제에 비해 출혈 결과를 상당히 감소시킨 것으로 나타났습니다. 동시 시술은 비절차적 출혈에서 44% 감소(8.0% vs. 13.3%)를 보였고, 순차적 시술은 36개월간 62% 감소(8.8% vs. 21.5%)를 보여주었습니다. 두 접근 모두 경구 항응고제에 비해 유사한 효능 결과와 뇌졸중 보호 효과를 유지했습니다.
Boston Scientific (BSX) a annoncé des données cliniques positives pour deux thérapies clés de fibrillation atriale lors du symposium AF 2025. L'essai ADVANTAGE AF pour le système FARAPULSE™ PFA a atteint ses objectifs principaux, montrant un taux d'événements indésirables de 2,3% et un taux d'efficacité de 63,5% dans le traitement des patients atteints de FA persistante, avec un taux sans récidive symptomatique de FA de 85,3%.
Une sous-analyse de l'essai OPTION a démontré que le dispositif WATCHMAN FLX™ réduisait significativement les résultats hémorragiques par rapport aux anticoagulants oraux. Les procédures concomitantes ont montré une réduction de 44% (8,0% contre 13,3%) tandis que les procédures séquentielles ont démontré une réduction de 62% (8,8% contre 21,5%) des hémorragies non procédurales après 36 mois. Les deux approches ont conservé des résultats d'efficacité similaires et une protection contre les AVC par rapport aux anticoagulants oraux.
Boston Scientific (BSX) gab beim AF Symposium 2025 positive klinische Daten zu zwei wichtigen Therapien für Vorhofflimmern bekannt. Die ADVANTAGE AF-Studie für das FARAPULSE™ PFA-System erreichte ihre primären Endpunkte und zeigte eine Sicherheitsereignisrate von 2,3% sowie eine Wirksamkeitsrate von 63,5% bei der Behandlung von Patienten mit persistierendem Vorhofflimmern, wobei eine Rückfallrate von 85,3% ohne Symptome beobachtet wurde.
Eine Subanalyse der OPTION-Studie zeigte, dass das WATCHMAN FLX™-Gerät die Blutungsergebnisse im Vergleich zu oralen Antikoagulanzien erheblich reduzierte. Bei den gleichzeitigen Verfahren wurde eine Reduktion von 44% (8,0% vs. 13,3%) beobachtet, während bei den sequentiellen Verfahren eine Reduktion von 62% (8,8% vs. 21,5%) bei nicht-prozeduralen Blutungen nach 36 Monaten festgestellt wurde. Beide Ansätze erhielten ähnliche Wirksamkeits- und Schlaganfallschutz-Ergebnisse im Vergleich zu oralen Antikoagulanzien.
- FARAPULSE PFA System achieved primary safety endpoint with low 2.3% event rate
- 85.3% symptomatic AF recurrence-free rate in ADVANTAGE AF trial
- WATCHMAN FLX device showed 44% reduction in bleeding outcomes for concomitant procedures
- 62% reduction in bleeding outcomes for sequential procedures with WATCHMAN FLX
- Similar efficacy outcomes and stroke protection compared to oral anticoagulants
- Primary effectiveness endpoint of 63.5% indicates treatment failure in 36.5% of cases
Insights
The late-breaking clinical trial results for Boston Scientific's FARAPULSE PFA System and WATCHMAN FLX Device represent significant clinical milestones with substantial market implications. The ADVANTAGE AF trial's success in treating persistent AF patients - representing 25% of all AF cases - opens a major new market opportunity beyond the current paroxysmal AF indication.
Key performance metrics are impressive: 85.3% symptomatic AF recurrence-free rate, improving to 91.8% with experienced operators, coupled with a low 2.3% adverse event rate. These outcomes position BSX competitively in the growing PFA market segment.
The OPTION trial sub-analysis reinforces WATCHMAN FLX's clinical value, demonstrating a 44% reduction in bleeding events for concomitant procedures and 62% for sequential procedures versus oral anticoagulants, while maintaining comparable stroke protection. This data strengthens the device's market position against both pharmaceutical alternatives and competing devices.
This data release strengthens Boston Scientific's competitive position in two key growth markets: cardiac ablation and left atrial appendage closure. The expanded indication potential for FARAPULSE in persistent AF patients could unlock a substantial revenue opportunity, considering these patients often require more complex and higher-priced procedures.
The WATCHMAN FLX data is particularly valuable as it supports both immediate post-ablation and delayed device implantation strategies, giving clinicians flexibility in treatment planning. This versatility, combined with superior bleeding risk reduction, should support continued market share gains in the LAAC segment, where BSX already holds a dominant position.
The timing of these presentations at AF Symposium 2025 is strategically important, as it allows BSX to showcase its innovation leadership to key opinion leaders and practitioners, potentially accelerating adoption rates for both technologies.
First phase of ADVANTAGE AF clinical trial achieves safety and effectiveness endpoints for treatment of drug-resistant, symptomatic, persistent atrial fibrillation with the FARAPULSE™ Pulsed Field Ablation System
Sub-analysis from OPTION clinical trial highlights consistent safety and efficacy outcomes with the WATCHMAN FLX™ Left Atrial Appendage Closure Device post cardiac ablation in both concomitant and sequential procedures
ADVANTAGE AF clinical study
Currently, the FARAPULSE PFA System is approved for pulmonary vein isolation (PVI) in patients who have paroxysmal AF, an irregular heartbeat that occurs occasionally and typically spontaneously resolves back to normal rhythm. The ADVANTAGE AF study examined use of the FARAPULSE PFA System for both PVI and posterior wall ablation (PWA) in patients who have persistent AF, where individuals experience an irregular or rapid heartbeat that lasts longer than seven days and which represent
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-esophageal fistula out to 12 months – was 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 – was met at
63.5% . - The symptomatic AF recurrence-free rate was
85.3% and observationally, among physicians that performed three or more procedures, the symptomatic recurrence-free rate increased to91.8% . - There were no reported incidences of stroke, pulmonary vein stenosis, atrio-esophageal 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, M.D.**, director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York and 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."
OPTION trial sub-analysis
The late-breaking session also included a prespecified sub-analysis from the OPTION clinical trial that built upon the positive primary endpoint results presented at the American Heart Association 2024 meeting and published in The New England Journal of Medicine.2 In line with the overall 36-month outcomes from this first head-to-head study of the WATCHMAN FLX device and direct oral anticoagulants (
- Consistent with the previously presented primary safety and efficacy endpoint data presented in November 2024, 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 (8.0% vs.13.3% ; p=0.02) and similar efficacy outcomes (7.0% 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 primary safety and efficacy endpoint 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). - Similar stroke protection with the WATCHMAN FLX device compared to OAC irrespective of concomitant (
2.3% vs.2.5% rates of all stroke) or sequential (1.1% vs1.6% ) 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 Dr. Brad
More information on the ADVANTAGE AF study is available here and on the OPTION trial here.***
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.
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*CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Ablation beyond pulmonary vein isolation is outside the use of labeled indication of the FARAWAVE PFA Catheter with the FARAPULSE PFA System.
**Dr. Vivek Reddy is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.
*** The FARAPULSE PFA System was not commercially available at the time of the OPTION trial initiation and was not included in the trial design.
1Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014;6:213-220. doi: 10.2147/CLEP.S47385
2 Wazni OM, Saliba WI, Nair DG, et al. Left atrial appendage closure after ablation for atrial fibrillation. N Engl J Med. 2024 Nov 16. doi:10.1056/NEJMoa2408308
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FAQ
What were the key results of BSX's ADVANTAGE AF trial for the FARAPULSE PFA System?
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