Boston Scientific Corporation unveiled promising outcomes from the OPTION global clinical study involving the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device, sharing three years of primary endpoint results. The study, which contrasted the device with initial oral anticoagulation (OAC) treatments like direct oral anticoagulants (DOAC) (95%) and warfarin (5%) for stroke risk reduction in patients with non-valvular atrial fibrillation post-cardiac ablation, was introduced in a recent groundbreaking science presentation at the American Heart Association’s 2024 Scientific Sessions and was concurrently published in The New England Journal of Medicine.
The trial reached the primary safety goal concerning major bleeding incidents or clinically relevant non-major bleeds at 36 months. The WATCHMAN FLX device demonstrated better performance than OAC (8.5% vs. 18.1%; P<0.0001). Furthermore, it achieved the primary efficacy goal of all-cause death, stroke, or systemic embolism at 36 months, revealing non-inferiority compared to OAC (5.4% vs. 5.8%; P<0.0001). Other notable results involved the WATCHMAN FLX device's non-inferiority in the combined secondary endpoint for procedural and non-procedural major bleeding at 36 months (3.9% vs. 5.0%; P<0.0001). The prevalence of atrial fibrillation patients undergoing cardiac ablation to alleviate symptoms has risen significantly in recent years. Since atrial fibrillation recurrence after ablation poses a risk, current guidelines suggest long-term OAC use for patients with multiple stroke risk factors. Despite this, many patients achieve symptomatic relief and discontinue blood thinners, heightening the stroke risk. Moreover, prolonged OAC use is associated with potential severe bleeding risks. "The findings from the OPTION trial furnish medical evidence indicating that LAAC with the WATCHMAN FLX device is not only safe but surpasses OAC therapy in reducing long-term bleeding risk in post-ablation patients," stated Dr. Oussama Wazni, vice chairman of cardiovascular medicine and section head of Cardiac Electrophysiology at Cleveland Clinic, as well as the principal investigator for the OPTION trial. * "Remarkably, patients who received a WATCHMAN FLX implant after ablation manifested high procedural success rates and adhered steadfastly to their prescribed medications, likely contributing to the trial's encouraging outcomes, such as reduced rates of ischemic and hemorrhagic stroke." The randomized, controlled OPTION trial enlisted 1,600 patients across 114 locations in the U.S., Europe, and Australia, yielding high procedural success rates. Notably, around 60% of the participants had their WATCHMAN FLX implant installed 90-180 days post-ablation, while nearly 40% underwent both procedures concurrently, with the WATCHMAN FLX implant following the ablation. "The OPTION trial stands as the first extensive, randomized study to thoroughly assess LAAC as a secure and effective stroke risk mitigation treatment post-cardiac ablation directly against widely used oral anticoagulants, including DOAC," expressed Brad Sutton, M.D., chief medical officer of Atrial Fibrillation Solutions at Boston Scientific. "The positive primary results indicate that patients equipped with the WATCHMAN FLX device could forgo long-term medication while retaining stroke protection. This data reveals avenues to broaden the WATCHMAN FLX platform's use and potentially establish it as a primary therapy for patients undergoing cardiac ablation to mitigate stroke risk." Besides the OPTION trial, WATCHMAN technology is being evaluated against DOACs as a primary therapy within the lower-risk patient segment in the CHAMPION-AF randomized trial. Concurrently, the latest WATCHMAN FLX Pro LAAC Device—approved in the U.S. in 2023—is undergoing scrutiny in various clinical investigations, including the SIMPLAAFY randomized controlled trial, which is examining a single-drug alternative to dual antiplatelet therapy as a post-procedural regimen. Boston Scientific is devoted to enhancing patient lives through trailblazing medical technology that elevates global health standards. A premier leader in medical technology for over 45 years, we are committed to advancing life by delivering a wide variety of high-performing solutions that address unmet patient demands and optimize healthcare cost efficiency.