OPTION Trial Sub-Analysis Reveals Promising Outcomes
The AF Symposium 2025 showcased a prespecified sub-analysis from the OPTION clinical trial, building upon the positive primary endpoint results previously presented. This analysis focused on 1,600 patients with atrial fibrillation who underwent device implantation either concomitantly or sequentially post-ablation.
Key Findings:
- Concomitant LAAC with WATCHMAN FLX Device: Demonstrated a statistically significant 44% reduction in non-procedural bleeding outcomes compared to oral anticoagulants (OAC) at 36 months (8.0% vs. 13.3%; p=0.02), with similar efficacy outcomes (7.0% vs. 6.7%; p=0.91).
- Sequential LAAC with WATCHMAN FLX Device: Showed a 62% reduction in non-procedural bleeding outcomes compared to OAC at 36 months (8.8% vs. 21.5%; p<0.0001), with similar efficacy outcomes (4.2% vs. 5.3%; p=0.45).
- Stroke Protection: The WATCHMAN FLX device provided similar stroke protection compared to OAC, irrespective of concomitant or sequential implantation.
Expert Commentary
Dr. Brad Sutton, M.D., chief medical officer of Atrial Fibrillation Solutions at Boston Scientific, emphasized the importance of these findings: "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."
Looking Ahead
These results not only validate the efficacy and safety of the WATCHMAN FLX device but also highlight the potential for expanding the patient population that can benefit from these therapies. Future clinical trials and product development efforts will continue to build on these promising outcomes.
For more detailed information on the ADVANTAGE AF study and the OPTION trial, interested readers are encouraged to visit the provided links.
