Boston Scientific Corp. (BSX) has reported promising three-year primary endpoint results from the OPTION global clinical trial involving the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device. This device has shown to significantly lower the risk of bleeding compared to oral anticoagulation therapies following cardiac ablation procedures.
The trial's data revealed that the stroke risk reduction efficacy of the device is comparable to that of oral anticoagulants for atrial fibrillation patients who have undergone cardiac ablation.
The company highlighted that the trial successfully met the primary safety endpoint concerning non-procedural major bleeding or clinically relevant non-major bleeding over a 36-month period. The WATCHMAN FLX device proved to be superior to oral anticoagulants in this regard. The primary efficacy endpoint, which included all-cause death, stroke, or systemic embolism, also showed the device's non-inferiority compared to oral anticoagulants over the same duration. Additional outcomes indicated that the WATCHMAN FLX device achieved non-inferiority for the combined secondary endpoint of procedural and non-procedural major bleeding at 36 months.
Recently, there has been a notable increase in the number of patients with atrial fibrillation undergoing cardiac ablation to manage symptoms. Current guidelines suggest that such patients with multiple stroke risk factors should continue using oral anticoagulants long-term to mitigate stroke risk. However, while symptom relief might lead patients to discontinue their blood thinners, potentially increasing stroke risk, the protracted use of oral anticoagulants can result in severe bleeding concerns.
The company further noted that the randomized, controlled OPTION trial involved 1,600 participants across 114 sites in the United States, Europe, and Australia, showcasing high procedural success rates. In about 60% of the trial participants, the WATCHMAN FLX device was implanted between 90 to 180 days post-ablation. The remaining participants underwent the device implantation concurrently with the ablation procedure.