Boston Scientific WATCHMAN FLX™ Left Atrial Appendage Closure Device Demonstrates Superior Bleeding Risk Reduction to Oral Anticoagulation Following a Cardiac Ablation in the OPTION Clinical Trial

Clinical Trial Results - The WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device demonstrated superiority to oral anticoagulation (OAC) in reducing non-procedural major bleeding or clinically relevant non-major bleeding at 36 months (8.5% vs. 18.1%; P<0.0001) [2] - The device showed non-inferiority to OAC for the primary efficacy endpoint of all-cause death, stroke, or systemic embolism at 36 months (5.4% vs. 5.8%; P<0.0001) [2] - The WATCHMAN FLX device also demonstrated non-inferiority for the combined secondary endpoint of procedural and non-procedural major bleeding at 36 months (3.9% vs. 5.0%; P<0.0001) [2] Patient Population and Procedure Details - The OPTION trial included 1,600 patients across 114 sites in the United States, Europe, and Australia [4] - Approximately 60% of device patients had their WATCHMAN FLX implant 90-180 days following their ablation procedure, while nearly 40% had the two procedures performed concomitantly [4] - The trial focused on patients with non-valvular atrial fibrillation following a cardiac ablation, comparing the device to first-line OAC, including direct oral anticoagulants (DOAC) (95%) and warfarin (5%) [1] Clinical Implications - The OPTION trial data suggest that LAAC with the WATCHMAN FLX device is not only as safe but superior to OAC therapy for reducing the risk of long-term bleeding events in patients who have undergone an ablation [4] - High rates of procedural success and patient adherence to prescribed medication regimens were observed, contributing to low rates of ischemic and hemorrhagic stroke within the trial population [4] - The trial results indicate potential for the WATCHMAN FLX platform to become a frontline therapy for patients receiving cardiac ablation for atrial fibrillation to reduce stroke risk [5] Ongoing and Future Research - The WATCHMAN technology is being evaluated against DOAC as a first-line therapy in lower-risk patients within the CHAMPION-AF randomized trial [5] - The latest-generation WATCHMAN FLX™ Pro LAAC Device, approved in the United States in 2023, is being studied in several clinical trials, including the SIMPLAAFY randomized controlled trial [5] Company Background - Boston Scientific Corporation is a global medical technology leader with over 45 years of experience, providing solutions for cardiovascular, respiratory, digestive, oncological, neurological, and urological diseases [7] - The company aims to improve patient health and reduce healthcare costs through innovative medical technologies [7]