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
Boston Scientific News
Boston Scientific Corporation announced data supporting the use of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device during a late-breaking science session at AF Symposium 2025.
A prespecified sub-analysis from the OPTION clinical trial built upon the positive primary endpoint results presented at the American Heart Association 2024 meeting and published in The New England Journal of Medicine.1 In line with the overall 36-month outcomes from this first head-to-head study of the WATCHMAN FLX device and direct oral anticoagulants (95% DOAC, 5% warfarin), the sub-analysis of 1,600 patients with atrial fibrillation who underwent a device implantation either concomitantly or sequentially (90-180 days post ablation) demonstrated:
- 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% 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, MD, 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."
More information on the the OPTION trial is availabe here.
1Wazni 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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