Oussama Wazni, MD, MBA: OPTION Trial and the Role of LAAC in Atrial Fibrillation

Results of the OPTION trial, which examined use of the WATCHMAN FLX device for left atrial appendage closure (LAAC) as part of a standard post-ablation strategy in atrial fibrillation, indicate the study met both its primary safety and efficacy endpoint, with the WATCHMAN FLX device demonstrating superiority to OAC for bleeding events and noninferiority for a composite of all-cause mortality, stroke, and systemic embolism at 36 months.¹

"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 principal investigator Oussama Wazni, MD, vice chairman of Cardiovascular Medicine and section head, Cardiac Electrophysiology, Cleveland Clinic.² "Notably, we found high rates of procedural success in patients who had a WATCHMAN FLX implant after an ablation, and of patient adherence to their prescribed medication regimen following the procedures, which likely reinforced positive outcomes such as the low rates of ischemic and hemorrhagic stroke within the trial population."

The trial, which was presented at the American Heart Association (AHA) Annual Scientific Sessions 2024, included 1600 patients. For inclusion patients needed to have atrial fibrillation, an elevated CHA2DS2-VASc scale, and have undergone catheter ablation. These patients were randomized in a 1:1 ratio to undergo LAAC or receive oral anticoagulation, with 803 patients randomized to LAAC and 797 randomized to anticoagulant therapy. The study cohort had a mean age of 69.6 (SD, 7.7) years, 34.1% were female, the mean CHA2DS2-VASc scale score was 3.5 (SD, 1.3).¹

The primary safety endpoint of the trial, which was tested for superiority was non-procedure-related major bleeding or clinically relevant nonmajor bleeding. The trial’s primary efficacy endpoint, which was tested for noninferiority, was a composite of all-cause mortality, stroke, or systemic embolism at 36 months.¹

Upon analysis, results indicated a primary safety endpoint event had occurred among 8.5% of the LAAC group and 18.1% of the anticoagulation group (P <.001 for superiority) at 36 months. Analysis of the primary efficacy endpoint suggested events occurred among 5.3% of the LAAC group and 5.8% of the anticoagulation group (P <.001 for noninferiority).¹

Since the trial was debuted at AHA 2024, it has been the subject of wide-reaching praise and criticisms, with some calling attention to the trial’s limitations, including a small sample size, use of a noninferiority endpoint, and leveraging an intention-to-treat analysis. For more on the results and his perspective on the trial's critiques, the HCPLive Cardiology editorial team caught up with Wazni on-site at AHA 2024.

Relevant disclosures for Wazni include Boston Scientific.

References:

1. Wazni OM. Randomized Comparison of Left Atrial Appendage Closure with Oral Anticoagulation after Catheter Ablation for Atrial Fibrillation. Paper presented at: American Heart Association Scientific Sessions 2024; November 15 - 18; Chicago, Il. Accessed November 16, 2024.
2. Boston Scientific Corporation. Boston Scientific Watchman FLXTM left atrial appendage closure device demonstrates superior bleeding risk reduction to oral anticoagulation following a cardiac ablation in the option clinical trial. Boston Scientific. November 16, 2024. Accessed November 17, 2024. https://news.bostonscientific.com/2024-11-16-Boston-Scientific-WATCHMAN-FLX-TM-Left-Atrial-Appendage-Closure-Device-Demonstrates-Superior-Bleeding-Risk-Reduction-to-Oral-Anticoagulation-Following-a-Cardiac-Ablation-in-the-OPTION-Clinical-Trial.