New data from the OPTION trial reveals that the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device from Boston Scientific offers a superior bleeding risk reduction compared to oral anticoagulants (OAC) in patients with non-valvular atrial fibrillation following cardiac ablation. The study, presented at the American Heart Association's Scientific Sessions 2024 and published in The New England Journal of Medicine, highlights the potential for patients to discontinue long-term OAC use while maintaining stroke protection.
OPTION Trial Results
The OPTION trial, a randomized controlled study involving 1,600 patients across 114 sites, compared the WATCHMAN FLX device to first-line OAC, including direct oral anticoagulants (DOAC) (95%) and warfarin (5%). The trial met its primary safety endpoint, demonstrating the WATCHMAN FLX device's superiority to OAC in non-procedural major bleeding or clinically relevant non-major bleeding at 36 months (8.5% vs. 18.1%; P<0.0001). It also met the primary efficacy endpoint, showing non-inferiority of the device to OAC for all-cause death, stroke, or systemic embolism at 36 months (5.4% vs. 5.8%; P<0.0001).
Additional findings included non-inferiority of the WATCHMAN FLX device for the combined secondary endpoint of procedural and non-procedural major bleeding at 36 months (3.9% vs. 5.0%; P<0.0001).
Clinical Implications
"The OPTION trial data provide clinical evidence indicating that, among patients who have undergone an ablation, 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," said Dr. Oussama Wazni, vice chairman of Cardiovascular Medicine and section head, Cardiac Electrophysiology, Cleveland Clinic, and principal investigator of the OPTION trial.
With the growing number of atrial fibrillation patients undergoing cardiac ablation to manage symptoms, the OPTION trial offers a promising alternative to long-term OAC, which carries a risk of serious bleeding. The trial demonstrated high procedural success rates, with approximately 60% of device patients receiving their WATCHMAN FLX implant 90-180 days post-ablation, and nearly 40% undergoing concomitant procedures.
Future Directions
"These positive primary outcomes mean that patients receiving the WATCHMAN FLX device were able to eliminate long-term medication use while maintaining stroke protection. With this data, we see potential to both expand the indication for the WATCHMAN FLX platform and ultimately elevate it to become a frontline therapy for patients receiving cardiac ablation for atrial fibrillation to reduce their risk of stroke," said Brad Sutton, M.D., chief medical officer, Atrial Fibrillation Solutions, Boston Scientific.
Boston Scientific is further evaluating the WATCHMAN technology against DOAC as a first-line therapy in lower-risk patients in the CHAMPION-AF trial. The latest-generation WATCHMAN FLX Pro LAAC Device is also being studied in trials like SIMPLAAFY, assessing single-drug alternatives to dual anti-platelet therapy post-procedure.
