Boston Scientific said that the OPTION trial of WATCHMAN FLX Left Atrial Appendage Closure (LAAC) device has demonstrated its effectiveness in reducing bleeding risks for patients with non-valvular atrial fibrillation following cardiac ablation.
The finding is part of the three-year results from the global clinical trial, which evaluated the WATCHMAN FLX LAAC device for reducing stroke risk in patients with non-valvular atrial fibrillation after cardiac ablation.
The results, presented at the American Heart Association’s Scientific Sessions 2024 and published in The New England Journal of Medicine, indicate the device’s effectiveness in reducing bleeding risks compared to first-line oral anticoagulation (OAC) therapies.
The OPTION trial assessed the WATCHMAN FLX device against OAC, including direct oral anticoagulants (DOACs) and warfarin, in a study involving 1,600 patients across 114 sites in the US, Europe, and Australia.
Results showed the device achieved the primary safety endpoint, reducing rates of non-procedural major bleeding or clinically relevant non-major bleeding over 36 months.
The WATCHMAN FLX also met the primary efficacy endpoint of all-cause death, stroke, or systemic embolism within 36 months, demonstrating non-inferiority to OAC. The device showed non-inferiority for a secondary combined endpoint, which included both procedural and non-procedural major bleeding.
Approximately 60% of patients in the OPTION trial had the WATCHMAN FLX implant procedure 90–180 days after their cardiac ablation. In contrast, nearly 40% underwent the device implantation concomitantly with the ablation procedure. Across all cases, the trial reported high procedural success rates.
Boston Scientific atrial fibrillation solutions chief medical officer Brad Sutton said: “The OPTION trial is the first large, randomised trial to rigorously evaluate LAAC as a safe and effective stroke risk reduction treatment following a cardiac ablation in a head-to-head fashion against commonly used oral anticoagulants, including DOAC.
“These positive primary outcomes mean that patients receiving the WATCHMAN FLX device were able to eliminate long-term medication use while maintaining stroke protection. With this data, we see potential to both expand the indication for the WATCHMAN FLX platform and ultimately elevate it to become a frontline therapy for patients receiving cardiac ablation for atrial fibrillation to reduce their risk of stroke.”
Boston Scientific is also exploring the WATCHMAN technology in other clinical settings. The CHAMPION-AF trial is evaluating the device as a first-line therapy against DOACs in lower-risk patients.
Additionally, the WATCHMAN FLX Pro LAAC device, approved in the US in 2023, is undergoing trials like SIMPLAAFY, which examines the efficacy of a single-drug alternative to dual antiplatelet therapy after implantation.
In a separate development, Boston Scientific completed its previously announced $3.7bn acquisition of Axonics, a medical technology company specialising in urinary and bowel dysfunction treatments.
Under the terms of the deal announced in January 2024, shareholders of the Nasdaq-listed Axonics are entitled to receive $71 in cash per share.
Axonics’ product portfolio includes the Axonics R20 and F15 Systems, which deliver sacral neuromodulation (SNM) therapy.
SNM therapy, a minimally invasive procedure, helps treat overactive bladder (OAB) and faecal incontinence by sending mild electrical pulses to the sacral nerve, restoring communication between the brain and bladder.
